Trial Outcomes & Findings for A Study of Avastin (Bevacizumab) in Combination Chemotherapy in Patients With Metastatic Cancer of the Colon or Rectum (NCT NCT01131078)
NCT ID: NCT01131078
Last Updated: 2015-06-04
Results Overview
Disease progression was defined according to National Cancer Institute (NCI) guidelines and best clinical practices.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
306 participants
Primary outcome timeframe
Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death
Results posted on
2015-06-04
Participant Flow
Participant milestones
| Measure |
Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2)
Bevacizumab was administered as a 7.5 milligrams per kilogram (mg/kg) intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 milligrams per meter squared (mg/m\^2) intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m\^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or stable disease (SD) were treated with bevacizumab alone until unacceptable toxicity, progressive disease (PD), or participant withdrawal.
|
Bevacizumab + Capecitabine (1250 mg/m^2)
Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle in combination with capecitabine administered orally at 1250 mg/m\^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
|
Bevacizumab + Capecitabine (650 mg/m^2)
Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 Week cycle in combination with capecitabine administered orally at 650 mg/m\^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of capecitabine treatment without interruptions. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.
|
|---|---|---|---|
|
Overall Study
STARTED
|
101
|
102
|
103
|
|
Overall Study
COMPLETED
|
0
|
1
|
1
|
|
Overall Study
NOT COMPLETED
|
101
|
101
|
102
|
Reasons for withdrawal
| Measure |
Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2)
Bevacizumab was administered as a 7.5 milligrams per kilogram (mg/kg) intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 milligrams per meter squared (mg/m\^2) intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m\^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or stable disease (SD) were treated with bevacizumab alone until unacceptable toxicity, progressive disease (PD), or participant withdrawal.
|
Bevacizumab + Capecitabine (1250 mg/m^2)
Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle in combination with capecitabine administered orally at 1250 mg/m\^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
|
Bevacizumab + Capecitabine (650 mg/m^2)
Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 Week cycle in combination with capecitabine administered orally at 650 mg/m\^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of capecitabine treatment without interruptions. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
22
|
12
|
17
|
|
Overall Study
Progressive Disease
|
58
|
77
|
71
|
|
Overall Study
Protocol Violation
|
1
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
4
|
3
|
|
Overall Study
Non-compliance
|
3
|
0
|
0
|
|
Overall Study
Physician Decision
|
10
|
6
|
8
|
|
Overall Study
Death
|
4
|
0
|
2
|
|
Overall Study
Other
|
0
|
1
|
0
|
Baseline Characteristics
A Study of Avastin (Bevacizumab) in Combination Chemotherapy in Patients With Metastatic Cancer of the Colon or Rectum
Baseline characteristics by cohort
| Measure |
Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2)
n=101 Participants
Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 mg/m\^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m\^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
|
Bevacizumab + Capecitabine (1250 mg/m^2)
n=102 Participants
Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle in combination with capecitabine administered orally at 1250 mg/m\^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
|
Bevacizumab + Capecitabine (650 mg/m^2)
n=103 Participants
Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 Week cycle in combination with capecitabine administered orally at 650 mg/m\^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of capecitabine treatment without interruptions. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.
|
Total
n=306 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
61.60 years
STANDARD_DEVIATION 9.35 • n=39 Participants
|
61.46 years
STANDARD_DEVIATION 10.22 • n=41 Participants
|
61.01 years
STANDARD_DEVIATION 10.10 • n=35 Participants
|
61.36 years
STANDARD_DEVIATION 9.86 • n=31 Participants
|
|
Sex: Female, Male
Female
|
58 Participants
n=39 Participants
|
53 Participants
n=41 Participants
|
63 Participants
n=35 Participants
|
174 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
43 Participants
n=39 Participants
|
49 Participants
n=41 Participants
|
40 Participants
n=35 Participants
|
132 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or DeathPopulation: ITT Population;
Disease progression was defined according to National Cancer Institute (NCI) guidelines and best clinical practices.
Outcome measures
| Measure |
Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2)
n=101 Participants
Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 mg/m\^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m\^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
|
Bevacizumab + Capecitabine (1250 mg/m^2)
n=102 Participants
Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 1250 mg/m\^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
|
Bevacizumab + Capecitabine (650 mg/m^2)
n=103 Participants
Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 650 mg/m\^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of continuous capecitabine treatment. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.
|
|---|---|---|---|
|
Percentage of Participants With Disease Progression or Death
|
86.14 percentage of participants
|
90.20 percentage of participants
|
88.35 percentage of participants
|
PRIMARY outcome
Timeframe: Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or DeathPopulation: ITT Population; only those participants with an event of disease progression or death were included in the analysis
TTP is defined as the time from date of randomization until objective tumor progression or death due to any cause. It includes deaths and thus can be correlated to overall survival.
Outcome measures
| Measure |
Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2)
n=87 Participants
Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 mg/m\^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m\^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
|
Bevacizumab + Capecitabine (1250 mg/m^2)
n=92 Participants
Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 1250 mg/m\^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
|
Bevacizumab + Capecitabine (650 mg/m^2)
n=91 Participants
Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 650 mg/m\^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of continuous capecitabine treatment. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.
|
|---|---|---|---|
|
Time to Progression (TTP)
|
8.35 months
Interval 7.23 to 9.6
|
8.15 months
Interval 6.74 to 8.75
|
7.27 months
Interval 4.57 to 8.98
|
SECONDARY outcome
Timeframe: Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or DeathPopulation: ITT Population
Overall survival is defined as the time from date of randomization until death from any cause
Outcome measures
| Measure |
Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2)
n=101 Participants
Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 mg/m\^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m\^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
|
Bevacizumab + Capecitabine (1250 mg/m^2)
n=102 Participants
Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 1250 mg/m\^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
|
Bevacizumab + Capecitabine (650 mg/m^2)
n=103 Participants
Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 650 mg/m\^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of continuous capecitabine treatment. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.
|
|---|---|---|---|
|
Percentage of Participants Who Died
|
67.33 percentage of participants
|
71.57 percentage of participants
|
73.79 percentage of participants
|
SECONDARY outcome
Timeframe: Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or DeathPopulation: ITT Population; Only participants with an event (death) were included in the analysis.
Overall survival is defined as the time from date of randomization until death from any cause; Kaplan-Meier estimates were used for analysis.
Outcome measures
| Measure |
Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2)
n=68 Participants
Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 mg/m\^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m\^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
|
Bevacizumab + Capecitabine (1250 mg/m^2)
n=73 Participants
Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 1250 mg/m\^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
|
Bevacizumab + Capecitabine (650 mg/m^2)
n=76 Participants
Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 650 mg/m\^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of continuous capecitabine treatment. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.
|
|---|---|---|---|
|
Overall Survival
|
22.75 months
Interval 18.94 to 26.63
|
19.76 months
Interval 18.38 to 24.0
|
18.02 months
Interval 14.76 to 20.61
|
SECONDARY outcome
Timeframe: Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or DeathPopulation: ITT Population
Treatment failure is defined as discontinuation of treatment for any reason, including disease progression, death, treatment toxicity, insufficient therapeutic response, failure to return, refusing treatment, being unwilling to cooperate and withdrawing consent.
Outcome measures
| Measure |
Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2)
n=101 Participants
Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 mg/m\^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m\^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
|
Bevacizumab + Capecitabine (1250 mg/m^2)
n=102 Participants
Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 1250 mg/m\^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
|
Bevacizumab + Capecitabine (650 mg/m^2)
n=103 Participants
Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 650 mg/m\^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of continuous capecitabine treatment. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.
|
|---|---|---|---|
|
Percentage of Participants With Treatment Failure
|
100.0 percentage of participants
|
99.02 percentage of participants
|
99.03 percentage of participants
|
SECONDARY outcome
Timeframe: Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or DeathPopulation: ITT Population; only participants with a treatment failure event were included in the analysis.
Time to treatment failure is defined as a composite endpoint measuring time from date of randomization to discontinuation of treatment for any reason, including disease progression, death, treatment toxicity, insufficient therapeutic response, failure to return, refusing treatment, being unwilling to cooperate and withdrawing consent. Analysis was performed using Kaplan-Meier estimates.
Outcome measures
| Measure |
Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2)
n=101 Participants
Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 mg/m\^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m\^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
|
Bevacizumab + Capecitabine (1250 mg/m^2)
n=101 Participants
Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 1250 mg/m\^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
|
Bevacizumab + Capecitabine (650 mg/m^2)
n=102 Participants
Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 650 mg/m\^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of continuous capecitabine treatment. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.
|
|---|---|---|---|
|
Time to Treatment Failure
|
6.67 months
Interval 5.82 to 7.56
|
6.87 months
Interval 5.49 to 8.38
|
5.75 months
Interval 4.34 to 7.27
|
SECONDARY outcome
Timeframe: Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or DeathPopulation: ITT Population
The failure event was defined as tumor progression excluding deaths due to any reason.
Outcome measures
| Measure |
Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2)
n=101 Participants
Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 mg/m\^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m\^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
|
Bevacizumab + Capecitabine (1250 mg/m^2)
n=102 Participants
Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 1250 mg/m\^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
|
Bevacizumab + Capecitabine (650 mg/m^2)
n=103 Participants
Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 650 mg/m\^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of continuous capecitabine treatment. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.
|
|---|---|---|---|
|
Percentage of Participants With Progression Excluding Deaths
|
71.29 percentage of participants
|
81.37 percentage of participants
|
75.73 percentage of participants
|
SECONDARY outcome
Timeframe: Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or DeathPopulation: ITT Population; Only participants with a time to progression event (excluding deaths) were included in the analysis.
The failure event was defined as tumor progression excluding deaths due to any reason. Kaplan-Meier estimates were used for analysis.
Outcome measures
| Measure |
Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2)
n=72 Participants
Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 mg/m\^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m\^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
|
Bevacizumab + Capecitabine (1250 mg/m^2)
n=83 Participants
Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 1250 mg/m\^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
|
Bevacizumab + Capecitabine (650 mg/m^2)
n=78 Participants
Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 650 mg/m\^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of continuous capecitabine treatment. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.
|
|---|---|---|---|
|
Time to Progression Excluding Deaths
|
8.81 months
Interval 7.66 to 10.82
|
8.48 months
Interval 6.9 to 8.84
|
7.40 months
Interval 4.87 to 9.17
|
SECONDARY outcome
Timeframe: Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or DeathPopulation: ITT Population
The failure event was defined as tumor progression excluding only deaths not related to underlying cancer.
Outcome measures
| Measure |
Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2)
n=101 Participants
Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 mg/m\^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m\^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
|
Bevacizumab + Capecitabine (1250 mg/m^2)
n=102 Participants
Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 1250 mg/m\^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
|
Bevacizumab + Capecitabine (650 mg/m^2)
n=103 Participants
Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 650 mg/m\^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of continuous capecitabine treatment. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.
|
|---|---|---|---|
|
Percentage of Participants With Progression Excluding Deaths Not Related to Underlying Cancer
|
81.19 percentage of participants
|
90.20 percentage of participants
|
85.44 percentage of participants
|
SECONDARY outcome
Timeframe: Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or DeathPopulation: ITT Population; only participants with a time to progression event (excluding deaths not related to underlying cancer) were included in the analysis.
The failure event was defined as tumor progression excluding only deaths not related to underlying cancer. Kaplan-Meier estimates were used for analysis.
Outcome measures
| Measure |
Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2)
n=82 Participants
Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 mg/m\^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m\^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
|
Bevacizumab + Capecitabine (1250 mg/m^2)
n=92 Participants
Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 1250 mg/m\^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
|
Bevacizumab + Capecitabine (650 mg/m^2)
n=88 Participants
Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 650 mg/m\^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of continuous capecitabine treatment. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.
|
|---|---|---|---|
|
Time to Progression Excluding Deaths Not Related to Underlying Cancer
|
8.68 months
Interval 7.59 to 9.9
|
8.32 months
Interval 6.74 to 8.75
|
7.27 months
Interval 4.57 to 9.11
|
SECONDARY outcome
Timeframe: Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or DeathPopulation: ITT Population; All participants with evaluable data were included in the analysis
Best overall response is defined as the best response recorded from the date of randomization until disease progression or recurrence. Complete response (CR): at least 2 determinations of CR at least 4 weeks apart before progression; Partial response (PR): at least 2 determinations of PR at least 4 weeks apart before progression; Stable disease (SD): at least one SD assessment; Progressive Disease (PD): Disease progression or death due to underlying cancer. CR: Complete disappearance of all target lesions; PR: At least 30% decrease in the sum of the longest diameter of all target lesions taking as reference the baseline sum of all target lesions; PD: At least 20% decrease in the sum of the longest diameter of all target lesions taking as reference the baseline sum of longest diameter of all target lesions or the appearance of one or more new lesions; SD: Neither sufficient shrinkage to qualify for CR or PR or increase in lesions;
Outcome measures
| Measure |
Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2)
n=91 Participants
Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 mg/m\^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m\^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
|
Bevacizumab + Capecitabine (1250 mg/m^2)
n=92 Participants
Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 1250 mg/m\^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
|
Bevacizumab + Capecitabine (650 mg/m^2)
n=94 Participants
Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 650 mg/m\^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of continuous capecitabine treatment. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.
|
|---|---|---|---|
|
Percentage of Participants by Best Overall Response
CR
|
5.49 percentage of participants
|
1.09 percentage of participants
|
5.32 percentage of participants
|
|
Percentage of Participants by Best Overall Response
PR
|
46.15 percentage of participants
|
32.61 percentage of participants
|
28.72 percentage of participants
|
|
Percentage of Participants by Best Overall Response
SD
|
39.56 percentage of participants
|
52.17 percentage of participants
|
45.74 percentage of participants
|
|
Percentage of Participants by Best Overall Response
PD
|
8.79 percentage of participants
|
14.13 percentage of participants
|
20.21 percentage of participants
|
SECONDARY outcome
Timeframe: Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or DeathPopulation: ITT Population; All participants with evaluable data were included in the analysis
CR: Complete disappearance of all target lesions; PR: At least 30% decrease in the sum of the longest diameter of all target lesions taking as reference the baseline sum of all target lesions;
Outcome measures
| Measure |
Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2)
n=91 Participants
Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 mg/m\^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m\^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
|
Bevacizumab + Capecitabine (1250 mg/m^2)
n=92 Participants
Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 1250 mg/m\^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
|
Bevacizumab + Capecitabine (650 mg/m^2)
n=94 Participants
Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 650 mg/m\^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of continuous capecitabine treatment. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.
|
|---|---|---|---|
|
Percentage of Participants With a Best Overall Response of CR or PR
|
52.0 percentage of participants
Interval 41.0 to 62.0
|
34.0 percentage of participants
Interval 24.0 to 44.0
|
34.0 percentage of participants
Interval 25.0 to 45.0
|
SECONDARY outcome
Timeframe: Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or DeathPopulation: ITT Population; All participants with evaluable data were included in the analysis
Stable disease rate was the proportion of participants who achieved CR, PR, or SD.
Outcome measures
| Measure |
Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2)
n=91 Participants
Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 mg/m\^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m\^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
|
Bevacizumab + Capecitabine (1250 mg/m^2)
n=92 Participants
Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 1250 mg/m\^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
|
Bevacizumab + Capecitabine (650 mg/m^2)
n=94 Participants
Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 650 mg/m\^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of continuous capecitabine treatment. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.
|
|---|---|---|---|
|
Percentage of Participants With Stable Disease
|
91.0 percentage of participants
Interval 83.0 to 96.0
|
86.0 percentage of participants
Interval 77.0 to 92.0
|
80.0 percentage of participants
Interval 70.0 to 87.0
|
SECONDARY outcome
Timeframe: Randomization, Weeks 3, 6 and 9, and 12Population: ITT Population; All participants with evaluable data were included in the analysis.
Early progression was the proportion of participants with progressive disease within 12 weeks from the start of treatment.
Outcome measures
| Measure |
Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2)
n=91 Participants
Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 mg/m\^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m\^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
|
Bevacizumab + Capecitabine (1250 mg/m^2)
n=92 Participants
Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 1250 mg/m\^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
|
Bevacizumab + Capecitabine (650 mg/m^2)
n=94 Participants
Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 650 mg/m\^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of continuous capecitabine treatment. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.
|
|---|---|---|---|
|
Percentage of Participants With Progressive Disease Within 12 Weeks From Start of Treatment
|
9.0 percentage of participants
Interval 4.0 to 17.0
|
13.0 percentage of participants
Interval 7.0 to 22.0
|
18.0 percentage of participants
Interval 11.0 to 27.0
|
SECONDARY outcome
Timeframe: Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or DeathPopulation: ITT Population; only participants with a best overall response of CR or PR were included in the analysis.
Duration of overall response included participants who achieved a CR or PR.
Outcome measures
| Measure |
Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2)
n=47 Participants
Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 mg/m\^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m\^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
|
Bevacizumab + Capecitabine (1250 mg/m^2)
n=31 Participants
Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 1250 mg/m\^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
|
Bevacizumab + Capecitabine (650 mg/m^2)
n=32 Participants
Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 650 mg/m\^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of continuous capecitabine treatment. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.
|
|---|---|---|---|
|
Duration of Overall Response
|
6.51 months
Interval 5.36 to 8.35
|
6.61 months
Interval 6.15 to 8.28
|
9.12 months
Interval 6.48 to 16.08
|
SECONDARY outcome
Timeframe: Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or DeathPopulation: ITT Population; Only participants with a best overall response of CR, PR, or SD were included in the analysis.
Duration of SD was calculated as the number of months the participants remained in CR, PR or SD. Kaplan-Meier estimates were used for analysis.
Outcome measures
| Measure |
Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2)
n=83 Participants
Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 mg/m\^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m\^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
|
Bevacizumab + Capecitabine (1250 mg/m^2)
n=79 Participants
Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 1250 mg/m\^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
|
Bevacizumab + Capecitabine (650 mg/m^2)
n=75 Participants
Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 650 mg/m\^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of continuous capecitabine treatment. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.
|
|---|---|---|---|
|
Duration of Stable Disease (SD)
|
8.81 months
Interval 7.86 to 10.55
|
8.65 months
Interval 7.99 to 9.34
|
8.98 months
Interval 7.3 to 9.99
|
SECONDARY outcome
Timeframe: Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 yearsPopulation: ITT Population; Only participants with a best overall response were included in the analysis.
Duration of complete response was calculated as the time in months from the date of randomization to the date of first documentation of CR. Kaplan-Meier estimates were used for analysis.
Outcome measures
| Measure |
Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2)
n=5 Participants
Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 mg/m\^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m\^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
|
Bevacizumab + Capecitabine (1250 mg/m^2)
n=1 Participants
Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 1250 mg/m\^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
|
Bevacizumab + Capecitabine (650 mg/m^2)
n=5 Participants
Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 650 mg/m\^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of continuous capecitabine treatment. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.
|
|---|---|---|---|
|
Duration of Overall Complete Response
|
8.35 months
Interval 5.16 to
Upper limit of the 95% confidence interval was not estimable as the duration of follow-up was not sufficient.
|
6.05 months
Number of participants analyzed for this parameter in this treatment group was 1, therefore 95% CI could not be determined.
|
12.89 months
Interval 7.63 to 33.04
|
Adverse Events
Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2)
Serious events: 38 serious events
Other events: 95 other events
Deaths: 0 deaths
Bevacizumab + Capecitabine (1250 mg/m^2)
Serious events: 21 serious events
Other events: 88 other events
Deaths: 0 deaths
Bevacizumab + Capecitabine (650 mg/m^2)
Serious events: 20 serious events
Other events: 85 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2)
n=100 participants at risk
Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 mg/m\^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m\^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
|
Bevacizumab + Capecitabine (1250 mg/m^2)
n=99 participants at risk
Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle in combination with capecitabine administered orally at 1250 mg/m\^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
|
Bevacizumab + Capecitabine (650 mg/m^2)
n=102 participants at risk
Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 Week cycle in combination with capecitabine administered orally at 650 mg/m\^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of capecitabine treatment without interruptions. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
3.0%
3/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.0%
1/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Gastrointestinal disorders
Diarrhoea
|
7.0%
7/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
1.0%
1/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.98%
1/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
6.0%
6/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
2.0%
2/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Gastrointestinal disorders
Vomiting
|
1.0%
1/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
1.0%
1/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
1.0%
1/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Blood and lymphatic system disorders
Leukopenia
|
2.0%
2/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
1.0%
1/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
1.0%
1/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.98%
1/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.98%
1/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Cardiac disorders
Myocardial infarction
|
2.0%
2/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Cardiac disorders
Myocardial ischemia
|
0.00%
0/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
1.0%
1/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Cardiac disorders
Supraventricular tachycardia
|
1.0%
1/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Gastrointestinal disorders
Abdominal haematoma
|
0.00%
0/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
1.0%
1/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.0%
1/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
2.0%
2/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
2.0%
2/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
1.0%
1/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Gastrointestinal disorders
Intestinal haemorrhage
|
0.00%
0/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.98%
1/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Gastrointestinal disorders
Intestinal prolapse
|
1.0%
1/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Gastrointestinal disorders
Nausea
|
1.0%
1/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.98%
1/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
1.0%
1/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Gastrointestinal disorders
Subileus
|
0.00%
0/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
1.0%
1/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Gastrointestinal disorders
Swollen tongue
|
0.00%
0/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
1.0%
1/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
General disorders
Chest pain
|
1.0%
1/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
General disorders
Disease progression
|
0.00%
0/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
1.0%
1/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
2.0%
2/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
General disorders
General physical health deterioration
|
1.0%
1/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
1.0%
1/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
1.0%
1/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
General disorders
Pyrexia
|
3.0%
3/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
1.0%
1/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.98%
1/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
General disorders
Sudden death
|
1.0%
1/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.00%
0/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.98%
1/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Infections and infestations
Central line infection
|
0.00%
0/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
1.0%
1/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Infections and infestations
Infection
|
0.00%
0/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.98%
1/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Infections and infestations
Septic shock
|
2.0%
2/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Infections and infestations
Tuberculosis
|
0.00%
0/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
1.0%
1/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Injury, poisoning and procedural complications
Device migration
|
1.0%
1/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
1.0%
1/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.98%
1/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.0%
1/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.0%
1/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung squamous cell carcinoma stage unspecified
|
1.0%
1/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
1.0%
1/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Nervous system disorders
Dizziness
|
2.0%
2/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
1.0%
1/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Nervous system disorders
Syncope
|
1.0%
1/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
1.0%
1/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Renal and urinary disorders
Calculus urinary
|
0.00%
0/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
1.0%
1/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Renal and urinary disorders
Hydronephrosis
|
1.0%
1/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.00%
0/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.98%
1/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Renal and urinary disorders
Renal failure
|
1.0%
1/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.98%
1/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Renal and urinary disorders
Renal vein thrombosis
|
0.00%
0/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.98%
1/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal oedema
|
0.00%
0/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
1.0%
1/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.0%
1/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
1.0%
1/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.98%
1/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary artery thrombosis
|
0.00%
0/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
1.0%
1/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.0%
2/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
2.0%
2/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary microemboll
|
0.00%
0/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.98%
1/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.98%
1/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Surgical and medical procedures
Toe amputation
|
0.00%
0/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
1.0%
1/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Vascular disorders
Deep vein thrombosis
|
2.0%
2/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
3.0%
3/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Vascular disorders
Embolism
|
0.00%
0/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.98%
1/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Vascular disorders
Hypertension
|
0.00%
0/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.98%
1/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
Other adverse events
| Measure |
Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2)
n=100 participants at risk
Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 mg/m\^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m\^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
|
Bevacizumab + Capecitabine (1250 mg/m^2)
n=99 participants at risk
Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle in combination with capecitabine administered orally at 1250 mg/m\^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
|
Bevacizumab + Capecitabine (650 mg/m^2)
n=102 participants at risk
Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 Week cycle in combination with capecitabine administered orally at 650 mg/m\^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of capecitabine treatment without interruptions. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.
|
|---|---|---|---|
|
Vascular disorders
Hypertension
|
28.0%
28/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
29.3%
29/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
18.6%
19/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
3.0%
3/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
1.0%
1/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Blood and lymphatic system disorders
Granulocytopenia
|
1.0%
1/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
1.0%
1/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
1.0%
1/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.98%
1/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
2.0%
2/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.98%
1/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
1.0%
1/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Cardiac disorders
Arrhythmia
|
1.0%
1/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Cardiac disorders
Atrial tachycardia
|
0.00%
0/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.98%
1/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
1.0%
1/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Cardiac disorders
Bradycardia
|
1.0%
1/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Cardiac disorders
Cyanosis
|
1.0%
1/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
2.0%
2/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.98%
1/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
1.0%
1/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Cardiac disorders
Extrasystoles
|
1.0%
1/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Blood and lymphatic system disorders
Anaemia
|
18.0%
18/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
7.1%
7/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
5.9%
6/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Blood and lymphatic system disorders
Leukopenia
|
7.0%
7/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
2.0%
2/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
2.0%
2/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Blood and lymphatic system disorders
Neutropenia
|
33.0%
33/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
5.1%
5/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
5.9%
6/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
5.0%
5/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
1.0%
1/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
2.0%
2/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Eye disorders
Conjunctivitis
|
1.0%
1/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
6.1%
6/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
2.0%
2/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Gastrointestinal disorders
Abdominal pain
|
21.0%
21/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
11.1%
11/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
20.6%
21/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
13.0%
13/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
8.1%
8/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
7.8%
8/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Gastrointestinal disorders
Constipation
|
12.0%
12/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
10.1%
10/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
7.8%
8/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Gastrointestinal disorders
Diarrhoea
|
56.0%
56/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
34.3%
34/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
27.5%
28/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Gastrointestinal disorders
Nausea
|
35.0%
35/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
16.2%
16/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
25.5%
26/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Gastrointestinal disorders
Stomatitis
|
6.0%
6/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
10.1%
10/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
2.0%
2/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Gastrointestinal disorders
Vomiting
|
23.0%
23/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
13.1%
13/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
5.9%
6/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
General disorders
Asthenia
|
16.0%
16/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
17.2%
17/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
19.6%
20/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
General disorders
Fatigue
|
14.0%
14/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
12.1%
12/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
15.7%
16/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
General disorders
Mucosal inflammation
|
13.0%
13/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
9.1%
9/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
6.9%
7/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
General disorders
Pyrexia
|
30.0%
30/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
17.2%
17/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
14.7%
15/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
10.0%
10/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
22.2%
22/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
25.5%
26/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Investigations
Alanine aminotransferase increased
|
7.0%
7/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
9.1%
9/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
11.8%
12/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Investigations
Aspartate aminotransferase increased
|
6.0%
6/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
8.1%
8/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
10.8%
11/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Investigations
Blood alkaline phosphatase increased
|
6.0%
6/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
4.0%
4/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
3.9%
4/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Metabolism and nutrition disorders
Anorexia
|
9.0%
9/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
5.1%
5/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
4.9%
5/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.0%
5/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
4.0%
4/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
3.9%
4/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.0%
5/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
2.0%
2/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
3.9%
4/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Nervous system disorders
Headache
|
4.0%
4/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
7.1%
7/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
4.9%
5/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Nervous system disorders
Cholinergic syndrome
|
5.0%
5/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.0%
5/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
3.0%
3/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
5.9%
6/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
4.0%
4/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
5.1%
5/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
5.9%
6/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
14.0%
14/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
6.1%
6/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
6.9%
7/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
22.0%
22/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
2.0%
2/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
2.9%
3/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
5.0%
5/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.98%
1/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
16.0%
16/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
40.4%
40/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
38.2%
39/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
1.0%
1/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.98%
1/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Ear and labyrinth disorders
Vertigo
|
1.0%
1/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
2.0%
2/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
2.9%
3/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
1.0%
1/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Eye disorders
Conjunctival haemorrhage
|
2.0%
2/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Eye disorders
Diplopia
|
0.00%
0/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
1.0%
1/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Eye disorders
Eye inflammation
|
0.00%
0/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.98%
1/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Eye disorders
Glaucoma
|
0.00%
0/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.98%
1/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Eye disorders
Ocular discomfort
|
1.0%
1/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Eye disorders
Ocular icterus
|
0.00%
0/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
1.0%
1/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Eye disorders
Vision blurred
|
0.00%
0/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
1.0%
1/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
1.0%
1/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.98%
1/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Gastrointestinal disorders
Anal discomfort
|
1.0%
1/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.98%
1/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Gastrointestinal disorders
Ano-rectal ulcer
|
0.00%
0/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
1.0%
1/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
1.0%
1/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.98%
1/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Gastrointestinal disorders
Cheilitis
|
1.0%
1/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Gastrointestinal disorders
Dry mouth
|
2.0%
2/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Gastrointestinal disorders
Dyspepsia
|
4.0%
4/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
3.0%
3/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
3.9%
4/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.98%
1/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Gastrointestinal disorders
Flatulence
|
2.0%
2/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
1.0%
1/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
1.0%
1/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
2.0%
2/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Gastrointestinal disorders
Gingivitis
|
1.0%
1/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.98%
1/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Gastrointestinal disorders
Haematochezia
|
3.0%
3/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
1.0%
1/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.98%
1/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Gastrointestinal disorders
Haemorrhoids
|
3.0%
3/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
2.0%
2/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
2.0%
2/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
1.0%
1/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Gastrointestinal disorders
Mesenteric vein thrombosis
|
0.00%
0/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.98%
1/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
0.00%
0/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.98%
1/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
3.0%
3/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Gastrointestinal disorders
Oral discomfort
|
1.0%
1/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Gastrointestinal disorders
Oedema peripheral
|
2.0%
2/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
1.0%
1/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.98%
1/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Gastrointestinal disorders
Periodontitis
|
1.0%
1/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Gastrointestinal disorders
Polyp colorectal
|
0.00%
0/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
1.0%
1/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
1.0%
1/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
2.0%
2/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Gastrointestinal disorders
Proctitis
|
2.0%
2/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
1.0%
1/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.98%
1/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
1.0%
1/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
2.0%
2/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
2.0%
2/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Gastrointestinal disorders
Toothache
|
1.0%
1/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
2.0%
2/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
General disorders
Catheter site related reaction
|
1.0%
1/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
General disorders
Chest discomfort
|
0.00%
0/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
1.0%
1/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.98%
1/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
General disorders
Chest pain
|
1.0%
1/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
3.0%
3/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
3.9%
4/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
General disorders
Facial pain
|
1.0%
1/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
General disorders
General physical health deterioration
|
1.0%
1/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
1.0%
1/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
2.0%
2/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
General disorders
Influenza-like illness
|
1.0%
1/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
3.0%
3/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.98%
1/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
General disorders
Local swelling
|
1.0%
1/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
General disorders
Malaise
|
0.00%
0/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
1.0%
1/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.98%
1/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
General disorders
Oedema peripheral
|
2.0%
2/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
1.0%
1/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.98%
1/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
General disorders
Pain
|
0.00%
0/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
2.0%
2/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.98%
1/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.98%
1/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Hepatobiliary disorders
Hepatic pain
|
1.0%
1/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Hepatobiliary disorders
Hepatotoxicity
|
1.0%
1/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.98%
1/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Hepatobiliary disorders
Jaundice
|
3.0%
3/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
2.0%
2/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Infections and infestations
Abdominal wall infection
|
0.00%
0/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
1.0%
1/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Infections and infestations
Bacteriuria
|
0.00%
0/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
1.0%
1/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
2.0%
2/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
2.0%
2/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
1.0%
1/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Infections and infestations
Cystitis
|
1.0%
1/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
4.0%
4/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.98%
1/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Infections and infestations
Dental caries
|
0.00%
0/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.98%
1/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Infections and infestations
Ear infection
|
0.00%
0/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.98%
1/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.98%
1/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Infections and infestations
Folliculitis
|
1.0%
1/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
1.0%
1/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Infections and infestations
Herpes zoster
|
2.0%
2/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.98%
1/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Infections and infestations
Influenza
|
3.0%
3/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
4.0%
4/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
4.9%
5/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Infections and infestations
Nail infection
|
0.00%
0/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
1.0%
1/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Infections and infestations
Paronychia
|
0.00%
0/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.98%
1/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Infections and infestations
Perianal abscess
|
0.00%
0/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
1.0%
1/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.98%
1/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Infections and infestations
Relapsing fever
|
0.00%
0/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.98%
1/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
1.0%
1/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
1.0%
1/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Infections and infestations
Tooth abscess
|
3.0%
3/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
1.0%
1/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
2.0%
2/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
2.9%
3/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Infections and infestations
Vaginal infection
|
1.0%
1/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Injury, poisoning and procedural complications
Intestinal stoma complication
|
1.0%
1/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
1.0%
1/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.98%
1/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
1.0%
1/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Injury, poisoning and procedural complications
Wound
|
1.0%
1/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
1.0%
1/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Investigations
Blood alkaline phosphatase
|
1.0%
1/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Investigations
Blood bilirubin
|
0.00%
0/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.98%
1/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Investigations
Blood calcium decreased
|
1.0%
1/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Investigations
Blood calcium increased
|
1.0%
1/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Investigations
Blood creatine increased
|
1.0%
1/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
1.0%
1/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Investigations
Blood creatinine increased
|
1.0%
1/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
4.0%
4/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
2.0%
2/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Investigations
Blood glucose increased
|
2.0%
2/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
1.0%
1/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.98%
1/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Investigations
Blood lactate dehydrogenase increased
|
2.0%
2/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
2.0%
2/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.98%
1/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Investigations
Blood sodium increased
|
1.0%
1/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Investigations
Coagulation test abnormal
|
1.0%
1/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
1.0%
1/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.98%
1/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Investigations
Haematocrit decreased
|
1.0%
1/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.98%
1/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Investigations
Platelet count increased
|
0.00%
0/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.98%
1/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Investigations
Prothrombin time shortened
|
1.0%
1/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Investigations
Transaminases increased
|
0.00%
0/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
3.0%
3/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Investigations
Weight decreased
|
1.0%
1/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
2.0%
2/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.0%
1/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
1.0%
1/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.98%
1/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Metabolism and nutrition disorders
Gout
|
1.0%
1/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
1.0%
1/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.98%
1/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
2.0%
2/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
1.0%
1/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
2.0%
2/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.98%
1/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
1.0%
1/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.98%
1/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
2.0%
2/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
1.0%
1/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
2.9%
3/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
1.0%
1/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
2.0%
2/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.98%
1/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
3.0%
3/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
1.0%
1/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
2.0%
2/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.98%
1/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
3.0%
3/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.98%
1/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Musculoskeletal and connective tissue disorders
Buttock pain
|
0.00%
0/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.98%
1/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
0.00%
0/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
2.0%
2/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.98%
1/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
2.0%
2/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
1.0%
1/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
1.0%
1/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.0%
1/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
2.0%
2/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.98%
1/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
2.0%
2/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
2.9%
3/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.0%
2/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
2.0%
2/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
4.9%
5/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.00%
0/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
1.0%
1/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Musculoskeletal and connective tissue disorders
Sacral pain
|
0.00%
0/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
1.0%
1/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Musculoskeletal and connective tissue disorders
Shoulder pain
|
3.0%
3/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
2.0%
2/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
2.0%
2/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
1.0%
1/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
1.0%
1/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Nervous system disorders
Coordination abnormal
|
0.00%
0/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
1.0%
1/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Nervous system disorders
Dizziness
|
3.0%
3/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.98%
1/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Nervous system disorders
Dysaesthesia
|
0.00%
0/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
1.0%
1/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Nervous system disorders
Dysguesia
|
1.0%
1/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.98%
1/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Nervous system disorders
Migraine without aura
|
2.0%
2/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Nervous system disorders
Neuropathy
|
3.0%
3/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.98%
1/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Nervous system disorders
Paraesthesia
|
4.0%
4/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
3.0%
3/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
4.9%
5/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Nervous system disorders
Sciatica
|
1.0%
1/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
3.0%
3/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
2.0%
2/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
1.0%
1/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Nervous system disorders
Syncope
|
2.0%
2/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
3.0%
3/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.98%
1/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Psychiatric disorders
Confusional state
|
1.0%
1/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.98%
1/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Psychiatric disorders
Depression
|
1.0%
1/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
1.0%
1/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
2.9%
3/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Psychiatric disorders
Insomnia
|
2.0%
2/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
2.0%
2/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.98%
1/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Psychiatric disorders
Mood altered
|
0.00%
0/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
1.0%
1/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.98%
1/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.98%
1/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Psychiatric disorders
Restlessness
|
1.0%
1/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Renal and urinary disorders
Bladder spasm
|
1.0%
1/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Renal and urinary disorders
Dysuria
|
2.0%
2/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Renal and urinary disorders
Nocturia
|
1.0%
1/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.98%
1/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.98%
1/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Renal and urinary disorders
Proteinuria
|
4.0%
4/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
4.0%
4/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
3.9%
4/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.98%
1/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Renal and urinary disorders
Renal failure acute
|
1.0%
1/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Renal and urinary disorders
Ureteric obstruction
|
0.00%
0/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
1.0%
1/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Renal and urinary disorders
Ureteric stenosis
|
0.00%
0/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
1.0%
1/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Reproductive system and breast disorders
Female genital-digestive tract fistula
|
1.0%
1/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Reproductive system and breast disorders
Pelvic pain
|
1.0%
1/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Reproductive system and breast disorders
Penis disorder
|
0.00%
0/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
3.0%
3/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.98%
1/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
2.0%
2/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
1.0%
1/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
2.0%
2/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
1.0%
1/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
4.0%
4/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
3.0%
3/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.98%
1/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
1.0%
1/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
1.0%
1/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Reproductive system and breast disorders
Rhinorrhoea
|
0.00%
0/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
1.0%
1/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
1.0%
1/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
2.0%
2/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.98%
1/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
0.00%
0/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.98%
1/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Skin and subcutaneous tissue disorders
Nail dystrophy
|
0.00%
0/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.98%
1/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Skin and subcutaneous tissue disorders
Onycholysis
|
0.00%
0/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
2.0%
2/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.00%
0/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.98%
1/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
1.0%
1/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
2.0%
2/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.0%
3/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
1.0%
1/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
2.9%
3/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.98%
1/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.98%
1/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
0.00%
0/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
2.0%
2/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
1.0%
1/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
1.0%
1/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Surgical and medical procedures
Cataract operation
|
0.00%
0/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
1.0%
1/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Surgical and medical procedures
Inguinal hernia repair
|
0.00%
0/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.98%
1/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Surgical and medical procedures
Stent placement
|
1.0%
1/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Surgical and medical procedures
Tooth extraction
|
0.00%
0/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
1.0%
1/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Vascular disorders
Axillary vein thrombosis
|
0.00%
0/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.98%
1/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Vascular disorders
Deep vein thrombosis
|
3.0%
3/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
1.0%
1/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.98%
1/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.98%
1/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Vascular disorders
Hypotension
|
1.0%
1/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
1.0%
1/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Vascular disorders
Phlebitis
|
1.0%
1/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
|
Vascular disorders
Thrombosis
|
2.0%
2/100 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.00%
0/99 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
0.98%
1/102 • Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
|
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 after the first publication or presentation that involves the overall study. Sponsor may request that confidential information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER