Trial Outcomes & Findings for Efficacy and Safety of Simtuzumab (SIM) With FOLFIRI as Second Line Treatment in Colorectal Adenocarcinoma (NCT NCT01479465)
NCT ID: NCT01479465
Last Updated: 2019-04-17
Results Overview
The PFS was defined as the time from the date of randomization to the earliest event time of: a) death regardless of cause, or b) first indication of disease progression. PFS was analyzed using Kaplan-Meier (KM) estimates.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
266 participants
Primary outcome timeframe
Randomization up to 27 months
Results posted on
2019-04-17
Participant Flow
Participants were enrolled at study sites in the United States, Russia, and Europe. The first participant was screened on 15 December 2011. The last study visit occurred on 27 February 2015.
358 participants were screened.
Participant milestones
| Measure |
FOLFIRI + SIM 700 mg (Part A)
Participants received simtuzumab (SIM) 700 mg via intravenous infusion followed by leucovorin (folinic acid), irinotecan, and fluorouracil (FOLFIRI; l-leucovorin 200 mg/m\^2 or dl-leucovorin 400 mg/m\^2 administered via intravenous infusion over 2 hours and irinotecan 180 mg/m\^2 administered via intravenous infusion over 90 minutes, followed by fluorouracil 400 mg/m\^2 administered via intravenous bolus and 2400 mg/m\^2 via intravenous infusion over 46 hours) on Days 1 and 15 of each 28-day treatment cycles for approximately 10 months.
|
FOLFIRI + Placebo (Part B)
Participants received placebo to match SIM via intravenous infusion followed by FOLFIRI via intravenous infusion on Days 1 and 15 of each 28-day treatment cycles for approximately 27 months.
|
FOLFIRI + SIM 200 mg (Part B)
Participants received SIM 200 mg via intravenous infusion followed by FOLFIRI via intravenous infusion on Days 1 and 15 of each 28-day treatment cycles for approximately 21 months.
|
FOLFIRI + SIM 700 mg (Part B)
Participants received SIM 700 mg via intravenous infusion followed by FOLFIRI via intravenous infusion on Days 1 and 15 of each 28-day treatment cycles for approximately 19 months.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
11
|
84
|
86
|
85
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
11
|
84
|
86
|
85
|
Reasons for withdrawal
| Measure |
FOLFIRI + SIM 700 mg (Part A)
Participants received simtuzumab (SIM) 700 mg via intravenous infusion followed by leucovorin (folinic acid), irinotecan, and fluorouracil (FOLFIRI; l-leucovorin 200 mg/m\^2 or dl-leucovorin 400 mg/m\^2 administered via intravenous infusion over 2 hours and irinotecan 180 mg/m\^2 administered via intravenous infusion over 90 minutes, followed by fluorouracil 400 mg/m\^2 administered via intravenous bolus and 2400 mg/m\^2 via intravenous infusion over 46 hours) on Days 1 and 15 of each 28-day treatment cycles for approximately 10 months.
|
FOLFIRI + Placebo (Part B)
Participants received placebo to match SIM via intravenous infusion followed by FOLFIRI via intravenous infusion on Days 1 and 15 of each 28-day treatment cycles for approximately 27 months.
|
FOLFIRI + SIM 200 mg (Part B)
Participants received SIM 200 mg via intravenous infusion followed by FOLFIRI via intravenous infusion on Days 1 and 15 of each 28-day treatment cycles for approximately 21 months.
|
FOLFIRI + SIM 700 mg (Part B)
Participants received SIM 700 mg via intravenous infusion followed by FOLFIRI via intravenous infusion on Days 1 and 15 of each 28-day treatment cycles for approximately 19 months.
|
|---|---|---|---|---|
|
Overall Study
Disease Progression
|
9
|
61
|
65
|
70
|
|
Overall Study
Study Discontinued by Sponsor
|
0
|
7
|
5
|
3
|
|
Overall Study
Adverse Event
|
0
|
3
|
6
|
4
|
|
Overall Study
Investigator Discretion
|
1
|
4
|
2
|
4
|
|
Overall Study
Subject Request
|
1
|
3
|
4
|
2
|
|
Overall Study
Subject Withdrew Consent
|
0
|
5
|
2
|
1
|
|
Overall Study
Protocol Violation
|
0
|
1
|
1
|
0
|
|
Overall Study
Death
|
0
|
0
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Participants in Full Analysis Set were analyzed.
Baseline characteristics by cohort
| Measure |
FOLFIRI + SIM 700 mg (Part A)
n=11 Participants
Participants received SIM 700 mg via intravenous infusion followed by FOLFIRI via intravenous infusion on Days 1 and 15 of each 28-day treatment cycles for approximately 10 months.
|
FOLFIRI + Placebo (Part B)
n=84 Participants
Participants received placebo to match SIM via intravenous infusion followed by FOLFIRI via intravenous infusion on Days 1 and 15 of each 28-day treatment cycles for approximately 27 months.
|
FOLFIRI + SIM 200 mg (Part B)
n=86 Participants
Participants received SIM 200 mg via intravenous infusion followed by FOLFIRI via intravenous infusion on Days 1 and 15 of each 28-day treatment cycles for approximately 21 months.
|
FOLFIRI + SIM 700 mg (Part B)
n=85 Participants
Participants received SIM 700 mg via intravenous infusion followed by FOLFIRI via intravenous infusion on Days 1 and 15 of each 28-day treatment cycles for approximately 19 months.
|
Total
n=266 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
Between 18 and 65 years
|
7 Participants
n=11 Participants • Participants in Full Analysis Set were analyzed.
|
57 Participants
n=80 Participants • Participants in Full Analysis Set were analyzed.
|
49 Participants
n=85 Participants • Participants in Full Analysis Set were analyzed.
|
56 Participants
n=84 Participants • Participants in Full Analysis Set were analyzed.
|
169 Participants
n=260 Participants • Participants in Full Analysis Set were analyzed.
|
|
Age, Customized
≥ 65 years
|
4 Participants
n=11 Participants • Participants in Full Analysis Set were analyzed.
|
23 Participants
n=80 Participants • Participants in Full Analysis Set were analyzed.
|
36 Participants
n=85 Participants • Participants in Full Analysis Set were analyzed.
|
28 Participants
n=84 Participants • Participants in Full Analysis Set were analyzed.
|
91 Participants
n=260 Participants • Participants in Full Analysis Set were analyzed.
|
|
Sex: Female, Male
Female
|
6 Participants
n=11 Participants • Participants in Full Analysis Set were analyzed.
|
41 Participants
n=80 Participants • Participants in Full Analysis Set were analyzed.
|
32 Participants
n=85 Participants • Participants in Full Analysis Set were analyzed.
|
48 Participants
n=84 Participants • Participants in Full Analysis Set were analyzed.
|
127 Participants
n=260 Participants • Participants in Full Analysis Set were analyzed.
|
|
Sex: Female, Male
Male
|
5 Participants
n=11 Participants • Participants in Full Analysis Set were analyzed.
|
39 Participants
n=80 Participants • Participants in Full Analysis Set were analyzed.
|
53 Participants
n=85 Participants • Participants in Full Analysis Set were analyzed.
|
36 Participants
n=84 Participants • Participants in Full Analysis Set were analyzed.
|
133 Participants
n=260 Participants • Participants in Full Analysis Set were analyzed.
|
|
Race/Ethnicity, Customized
Race · White
|
8 Participants
n=11 Participants • Participants in Full Analysis Set were analyzed.
|
67 Participants
n=80 Participants • Participants in Full Analysis Set were analyzed.
|
74 Participants
n=85 Participants • Participants in Full Analysis Set were analyzed.
|
71 Participants
n=84 Participants • Participants in Full Analysis Set were analyzed.
|
220 Participants
n=260 Participants • Participants in Full Analysis Set were analyzed.
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
2 Participants
n=11 Participants • Participants in Full Analysis Set were analyzed.
|
8 Participants
n=80 Participants • Participants in Full Analysis Set were analyzed.
|
5 Participants
n=85 Participants • Participants in Full Analysis Set were analyzed.
|
7 Participants
n=84 Participants • Participants in Full Analysis Set were analyzed.
|
22 Participants
n=260 Participants • Participants in Full Analysis Set were analyzed.
|
|
Race/Ethnicity, Customized
Race · Asian
|
1 Participants
n=11 Participants • Participants in Full Analysis Set were analyzed.
|
1 Participants
n=80 Participants • Participants in Full Analysis Set were analyzed.
|
5 Participants
n=85 Participants • Participants in Full Analysis Set were analyzed.
|
1 Participants
n=84 Participants • Participants in Full Analysis Set were analyzed.
|
8 Participants
n=260 Participants • Participants in Full Analysis Set were analyzed.
|
|
Race/Ethnicity, Customized
Race · Native Hawaiian or Pacific Islander
|
0 Participants
n=11 Participants • Participants in Full Analysis Set were analyzed.
|
1 Participants
n=80 Participants • Participants in Full Analysis Set were analyzed.
|
0 Participants
n=85 Participants • Participants in Full Analysis Set were analyzed.
|
1 Participants
n=84 Participants • Participants in Full Analysis Set were analyzed.
|
2 Participants
n=260 Participants • Participants in Full Analysis Set were analyzed.
|
|
Race/Ethnicity, Customized
Race · Not Permitted
|
0 Participants
n=11 Participants • Participants in Full Analysis Set were analyzed.
|
3 Participants
n=80 Participants • Participants in Full Analysis Set were analyzed.
|
1 Participants
n=85 Participants • Participants in Full Analysis Set were analyzed.
|
3 Participants
n=84 Participants • Participants in Full Analysis Set were analyzed.
|
7 Participants
n=260 Participants • Participants in Full Analysis Set were analyzed.
|
|
Race/Ethnicity, Customized
Race · Missing
|
0 Participants
n=11 Participants • Participants in Full Analysis Set were analyzed.
|
0 Participants
n=80 Participants • Participants in Full Analysis Set were analyzed.
|
0 Participants
n=85 Participants • Participants in Full Analysis Set were analyzed.
|
1 Participants
n=84 Participants • Participants in Full Analysis Set were analyzed.
|
1 Participants
n=260 Participants • Participants in Full Analysis Set were analyzed.
|
|
Race/Ethnicity, Customized
Ethnicity · Non-Hispanic/Latino
|
8 Participants
n=11 Participants • Participants in Full Analysis Set were analyzed.
|
70 Participants
n=80 Participants • Participants in Full Analysis Set were analyzed.
|
75 Participants
n=85 Participants • Participants in Full Analysis Set were analyzed.
|
73 Participants
n=84 Participants • Participants in Full Analysis Set were analyzed.
|
226 Participants
n=260 Participants • Participants in Full Analysis Set were analyzed.
|
|
Race/Ethnicity, Customized
Ethnicity · Hispanic/Latino
|
3 Participants
n=11 Participants • Participants in Full Analysis Set were analyzed.
|
5 Participants
n=80 Participants • Participants in Full Analysis Set were analyzed.
|
7 Participants
n=85 Participants • Participants in Full Analysis Set were analyzed.
|
8 Participants
n=84 Participants • Participants in Full Analysis Set were analyzed.
|
23 Participants
n=260 Participants • Participants in Full Analysis Set were analyzed.
|
|
Race/Ethnicity, Customized
Ethnicity · Not Permitted
|
0 Participants
n=11 Participants • Participants in Full Analysis Set were analyzed.
|
5 Participants
n=80 Participants • Participants in Full Analysis Set were analyzed.
|
3 Participants
n=85 Participants • Participants in Full Analysis Set were analyzed.
|
3 Participants
n=84 Participants • Participants in Full Analysis Set were analyzed.
|
11 Participants
n=260 Participants • Participants in Full Analysis Set were analyzed.
|
|
Region of Enrollment
United States
|
11 Participants
n=11 Participants
|
45 Participants
n=84 Participants
|
47 Participants
n=86 Participants
|
45 Participants
n=85 Participants
|
148 Participants
n=266 Participants
|
|
Region of Enrollment
Poland
|
0 Participants
n=11 Participants
|
5 Participants
n=84 Participants
|
7 Participants
n=86 Participants
|
5 Participants
n=85 Participants
|
17 Participants
n=266 Participants
|
|
Region of Enrollment
Italy
|
0 Participants
n=11 Participants
|
7 Participants
n=84 Participants
|
7 Participants
n=86 Participants
|
4 Participants
n=85 Participants
|
18 Participants
n=266 Participants
|
|
Region of Enrollment
France
|
0 Participants
n=11 Participants
|
4 Participants
n=84 Participants
|
1 Participants
n=86 Participants
|
3 Participants
n=85 Participants
|
8 Participants
n=266 Participants
|
|
Region of Enrollment
Germany
|
0 Participants
n=11 Participants
|
5 Participants
n=84 Participants
|
4 Participants
n=86 Participants
|
7 Participants
n=85 Participants
|
16 Participants
n=266 Participants
|
|
Region of Enrollment
Spain
|
0 Participants
n=11 Participants
|
9 Participants
n=84 Participants
|
13 Participants
n=86 Participants
|
8 Participants
n=85 Participants
|
30 Participants
n=266 Participants
|
|
Region of Enrollment
Russia
|
0 Participants
n=11 Participants
|
9 Participants
n=84 Participants
|
7 Participants
n=86 Participants
|
13 Participants
n=85 Participants
|
29 Participants
n=266 Participants
|
PRIMARY outcome
Timeframe: Randomization up to 27 monthsPopulation: Full Analysis Set included participants who were randomized and received at least 1 dose of study drug.
The PFS was defined as the time from the date of randomization to the earliest event time of: a) death regardless of cause, or b) first indication of disease progression. PFS was analyzed using Kaplan-Meier (KM) estimates.
Outcome measures
| Measure |
FOLFIRI + SIM 700 mg (Part A)
n=11 Participants
Participants received SIM 700 mg via intravenous infusion followed by FOLFIRI via intravenous infusion on Days 1 and 15 of each 28-day treatment cycles for approximately 10 months.
|
FOLFIRI + Placebo (Part B)
n=80 Participants
Participants received placebo to match SIM via intravenous infusion followed by FOLFIRI via intravenous infusion on Days 1 and 15 of each 28-day treatment cycles for approximately 27 months.
|
FOLFIRI + SIM 200 mg (Part B)
n=85 Participants
Participants received SIM 200 mg via intravenous infusion followed by FOLFIRI via intravenous infusion on Days 1 and 15 of each 28-day treatment cycles for approximately 21 months.
|
FOLFIRI + SIM 700 mg (Part B)
n=84 Participants
Participants received SIM 700 mg via intravenous infusion followed by FOLFIRI via intravenous infusion on Days 1 and 15 of each 28-day treatment cycles for approximately 19 months.
|
|---|---|---|---|---|
|
Progression Free Survival (PFS)
|
5.7 months
Interval 1.8 to 10.0
|
5.8 months
Interval 4.9 to 9.0
|
5.4 months
Interval 3.4 to 5.6
|
5.5 months
Interval 4.0 to 7.1
|
SECONDARY outcome
Timeframe: Randomization up to 33 monthsPopulation: Participants in the Full Analysis Set were analyzed.
The OS is measured as time from date of randomization to death regardless of cause. The OS was analyzed using KM estimates.
Outcome measures
| Measure |
FOLFIRI + SIM 700 mg (Part A)
n=11 Participants
Participants received SIM 700 mg via intravenous infusion followed by FOLFIRI via intravenous infusion on Days 1 and 15 of each 28-day treatment cycles for approximately 10 months.
|
FOLFIRI + Placebo (Part B)
n=80 Participants
Participants received placebo to match SIM via intravenous infusion followed by FOLFIRI via intravenous infusion on Days 1 and 15 of each 28-day treatment cycles for approximately 27 months.
|
FOLFIRI + SIM 200 mg (Part B)
n=85 Participants
Participants received SIM 200 mg via intravenous infusion followed by FOLFIRI via intravenous infusion on Days 1 and 15 of each 28-day treatment cycles for approximately 21 months.
|
FOLFIRI + SIM 700 mg (Part B)
n=84 Participants
Participants received SIM 700 mg via intravenous infusion followed by FOLFIRI via intravenous infusion on Days 1 and 15 of each 28-day treatment cycles for approximately 19 months.
|
|---|---|---|---|---|
|
Overall Survival (OS)
|
9.8 months
Interval 3.5 to 22.3
|
16.3 months
Interval 12.0 to 19.5
|
10.5 months
Interval 9.2 to 12.6
|
11.4 months
Interval 9.7 to 15.6
|
SECONDARY outcome
Timeframe: Randomization up to 27 monthsPopulation: Participants in the Full Analysis Set were analyzed.
Objective response was assessed using the Response Evaluation Criteria in Solid Tumors (RECIST) criteria (version 1.1) as Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD). The ORR was defined as the percentage of participants who achieved a CR or PR.
Outcome measures
| Measure |
FOLFIRI + SIM 700 mg (Part A)
n=11 Participants
Participants received SIM 700 mg via intravenous infusion followed by FOLFIRI via intravenous infusion on Days 1 and 15 of each 28-day treatment cycles for approximately 10 months.
|
FOLFIRI + Placebo (Part B)
n=80 Participants
Participants received placebo to match SIM via intravenous infusion followed by FOLFIRI via intravenous infusion on Days 1 and 15 of each 28-day treatment cycles for approximately 27 months.
|
FOLFIRI + SIM 200 mg (Part B)
n=85 Participants
Participants received SIM 200 mg via intravenous infusion followed by FOLFIRI via intravenous infusion on Days 1 and 15 of each 28-day treatment cycles for approximately 21 months.
|
FOLFIRI + SIM 700 mg (Part B)
n=84 Participants
Participants received SIM 700 mg via intravenous infusion followed by FOLFIRI via intravenous infusion on Days 1 and 15 of each 28-day treatment cycles for approximately 19 months.
|
|---|---|---|---|---|
|
Objective Response Rate (ORR)
|
9.1 percentage of participants
Interval 0.2 to 41.3
|
10.0 percentage of participants
Interval 4.4 to 18.8
|
5.9 percentage of participants
Interval 1.9 to 13.2
|
11.9 percentage of participants
Interval 5.9 to 20.8
|
Adverse Events
FOLFIRI + SIM 700 mg (Part A)
Serious events: 4 serious events
Other events: 11 other events
Deaths: 0 deaths
FOLFIRI + Placebo (Part B)
Serious events: 27 serious events
Other events: 76 other events
Deaths: 0 deaths
FOLFIRI + SIM 200 mg (Part B)
Serious events: 24 serious events
Other events: 80 other events
Deaths: 0 deaths
FOLFIRI + SIM 700 mg (Part B)
Serious events: 17 serious events
Other events: 79 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
FOLFIRI + SIM 700 mg (Part A)
n=11 participants at risk
Participants received SIM 700 mg via intravenous infusion followed by FOLFIRI via intravenous infusion on Days 1 and 15 of each 28-day treatment cycles for approximately 10 months.
|
FOLFIRI + Placebo (Part B)
n=80 participants at risk
Participants received placebo to match SIM via intravenous infusion followed by FOLFIRI via intravenous infusion on Days 1 and 15 of each 28-day treatment cycles for approximately 27 months.
|
FOLFIRI + SIM 200 mg (Part B)
n=85 participants at risk
Participants received SIM 200 mg via intravenous infusion followed by FOLFIRI via intravenous infusion on Days 1 and 15 of each 28-day treatment cycles for approximately 21 months.
|
FOLFIRI + SIM 700 mg (Part B)
n=84 participants at risk
Participants received SIM 700 mg via intravenous infusion followed by FOLFIRI via intravenous infusion on Days 1 and 15 of each 28-day treatment cycles for approximately 19 months.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Subileus
|
0.00%
0/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
2.5%
2/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
3.8%
3/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
2.4%
2/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
1.2%
1/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
General disorders
Asthenia
|
0.00%
0/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
1.2%
1/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
General disorders
Death
|
0.00%
0/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
1.2%
1/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
General disorders
General physical health deterioration
|
0.00%
0/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
1.2%
1/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
General disorders
Pyrexia
|
0.00%
0/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
2.4%
2/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
1.2%
1/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
1.2%
1/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Infections and infestations
Device related infection
|
0.00%
0/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
1.2%
1/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
1.2%
1/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
1.2%
1/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
2.5%
2/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
1.2%
1/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
1.2%
1/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Infections and infestations
Influenza
|
0.00%
0/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
1.2%
1/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Infections and infestations
Klebsiella infection
|
0.00%
0/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
1.2%
1/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Infections and infestations
Lung infection
|
0.00%
0/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
1.2%
1/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
2.5%
2/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
1.2%
1/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
1.2%
1/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
1.2%
1/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Infections and infestations
Sepsis
|
9.1%
1/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
1.2%
1/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
3.6%
3/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
1.2%
1/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
1.2%
1/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
1.2%
1/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
1.2%
1/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
1.2%
1/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
1.2%
1/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
1.2%
1/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
1.2%
1/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Investigations
Urine output decreased
|
0.00%
0/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
1.2%
1/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
2.5%
2/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
1.2%
1/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
9.1%
1/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
9.1%
1/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
1.2%
1/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
1.2%
1/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
1.2%
1/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
1.2%
1/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
1.2%
1/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
1.2%
1/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant ascites
|
0.00%
0/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
1.2%
1/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
1.2%
1/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour thrombosis
|
0.00%
0/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
1.2%
1/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
1.2%
1/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
1.2%
1/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
1.2%
1/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
1.2%
1/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
1.2%
1/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
1.2%
1/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
1.2%
1/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Renal and urinary disorders
Renal failure acute
|
9.1%
1/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
1.2%
1/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Renal and urinary disorders
Urinary tract disorder
|
0.00%
0/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
1.2%
1/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
9.1%
1/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Respiratory, thoracic and mediastinal disorders
Lower respiratory tract inflammation
|
0.00%
0/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
1.2%
1/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
1.2%
1/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
5.0%
4/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
2.4%
2/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
2.4%
2/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary infarction
|
0.00%
0/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
1.2%
1/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
1.2%
1/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
1.2%
1/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
1.2%
1/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Vascular disorders
Superior vena cava occlusion
|
0.00%
0/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
1.2%
1/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Vascular disorders
Venous thrombosis
|
0.00%
0/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
1.2%
1/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Blood and lymphatic system disorders
Anaemia
|
9.1%
1/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
1.2%
1/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
3.6%
3/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
2.5%
2/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
3.5%
3/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
1.2%
1/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
1.2%
1/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
1.2%
1/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
3.8%
3/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
1.2%
1/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
2.4%
2/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
1.2%
1/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
1.2%
1/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
1.2%
1/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Cardiac disorders
Atrial fibrillation
|
9.1%
1/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
1.2%
1/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
1.2%
1/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
1.2%
1/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Gastrointestinal disorders
Abdominal pain
|
9.1%
1/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
2.5%
2/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
1.2%
1/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Gastrointestinal disorders
Anal fistula
|
0.00%
0/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
1.2%
1/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
1.2%
1/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
3.5%
3/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
1.2%
1/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
1.2%
1/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
2.4%
2/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
1.2%
1/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.00%
0/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
1.2%
1/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
1.2%
1/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
2.5%
2/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
1.2%
1/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
1.2%
1/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
1.2%
1/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
Other adverse events
| Measure |
FOLFIRI + SIM 700 mg (Part A)
n=11 participants at risk
Participants received SIM 700 mg via intravenous infusion followed by FOLFIRI via intravenous infusion on Days 1 and 15 of each 28-day treatment cycles for approximately 10 months.
|
FOLFIRI + Placebo (Part B)
n=80 participants at risk
Participants received placebo to match SIM via intravenous infusion followed by FOLFIRI via intravenous infusion on Days 1 and 15 of each 28-day treatment cycles for approximately 27 months.
|
FOLFIRI + SIM 200 mg (Part B)
n=85 participants at risk
Participants received SIM 200 mg via intravenous infusion followed by FOLFIRI via intravenous infusion on Days 1 and 15 of each 28-day treatment cycles for approximately 21 months.
|
FOLFIRI + SIM 700 mg (Part B)
n=84 participants at risk
Participants received SIM 700 mg via intravenous infusion followed by FOLFIRI via intravenous infusion on Days 1 and 15 of each 28-day treatment cycles for approximately 19 months.
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
12.5%
10/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
5.9%
5/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
4.8%
4/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
18.2%
2/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
1.2%
1/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
1.2%
1/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
1.2%
1/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Blood and lymphatic system disorders
Anaemia
|
27.3%
3/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
23.8%
19/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
27.1%
23/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
21.4%
18/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Blood and lymphatic system disorders
Leukopenia
|
9.1%
1/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
11.2%
9/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
15.3%
13/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
15.5%
13/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Blood and lymphatic system disorders
Neutropenia
|
54.5%
6/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
43.8%
35/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
49.4%
42/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
47.6%
40/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
7.5%
6/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
11.8%
10/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
13.1%
11/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Cardiac disorders
Arrhythmia
|
9.1%
1/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Cardiac disorders
Atrial fibrillation
|
9.1%
1/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Cardiac disorders
Cardiac failure congestive
|
9.1%
1/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Cardiac disorders
Palpitations
|
9.1%
1/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Eye disorders
Eye pain
|
9.1%
1/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Eye disorders
Ocular hyperaemia
|
9.1%
1/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
1.2%
1/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
9.1%
1/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
2.5%
2/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
2.4%
2/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Gastrointestinal disorders
Abdominal distension
|
18.2%
2/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
5.0%
4/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
2.4%
2/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
1.2%
1/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Gastrointestinal disorders
Abdominal pain
|
36.4%
4/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
22.5%
18/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
18.8%
16/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
26.2%
22/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
6.2%
5/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
2.4%
2/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
18.2%
2/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
7.5%
6/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
9.4%
8/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
7.1%
6/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Gastrointestinal disorders
Constipation
|
36.4%
4/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
21.2%
17/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
21.2%
18/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
25.0%
21/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Gastrointestinal disorders
Diarrhoea
|
81.8%
9/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
53.8%
43/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
42.4%
36/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
50.0%
42/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Gastrointestinal disorders
Dry mouth
|
9.1%
1/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
8.8%
7/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
2.4%
2/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
3.6%
3/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Gastrointestinal disorders
Dyspepsia
|
27.3%
3/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
8.8%
7/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
4.7%
4/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
4.8%
4/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Gastrointestinal disorders
Dysphagia
|
18.2%
2/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
5.0%
4/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
1.2%
1/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
18.2%
2/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
3.8%
3/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
3.5%
3/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
1.2%
1/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Gastrointestinal disorders
Haematochezia
|
9.1%
1/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
2.5%
2/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
1.2%
1/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Gastrointestinal disorders
Nausea
|
81.8%
9/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
46.2%
37/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
44.7%
38/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
50.0%
42/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Gastrointestinal disorders
Oral mucosal erythema
|
9.1%
1/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Gastrointestinal disorders
Oral pain
|
9.1%
1/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
2.5%
2/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
3.5%
3/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
1.2%
1/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
18.2%
2/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
1.2%
1/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Gastrointestinal disorders
Stomatitis
|
9.1%
1/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
21.2%
17/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
16.5%
14/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
10.7%
9/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Gastrointestinal disorders
Vomiting
|
45.5%
5/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
31.2%
25/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
24.7%
21/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
27.4%
23/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
General disorders
Asthenia
|
18.2%
2/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
15.0%
12/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
15.3%
13/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
14.3%
12/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
General disorders
Axillary pain
|
9.1%
1/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
General disorders
Catheter site pain
|
9.1%
1/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
1.2%
1/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
1.2%
1/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
General disorders
Catheter site rash
|
9.1%
1/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
1.2%
1/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
General disorders
Chest discomfort
|
9.1%
1/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
1.2%
1/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
1.2%
1/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
General disorders
Chest pain
|
0.00%
0/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
3.8%
3/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
1.2%
1/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
6.0%
5/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
General disorders
Fatigue
|
81.8%
9/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
42.5%
34/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
44.7%
38/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
51.2%
43/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
General disorders
Feeling abnormal
|
9.1%
1/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
1.2%
1/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
General disorders
Feeling jittery
|
9.1%
1/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
General disorders
Malaise
|
9.1%
1/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
1.2%
1/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
1.2%
1/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
6.0%
5/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
General disorders
Mucosal inflammation
|
27.3%
3/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
12.5%
10/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
16.5%
14/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
8.3%
7/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
General disorders
Oedema peripheral
|
0.00%
0/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
5.0%
4/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
16.5%
14/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
11.9%
10/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
General disorders
Pyrexia
|
9.1%
1/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
13.8%
11/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
11.8%
10/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
13.1%
11/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Infections and infestations
Infection
|
9.1%
1/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
1.2%
1/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Infections and infestations
Nasopharyngitis
|
9.1%
1/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
1.2%
1/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
2.4%
2/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
2.4%
2/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Infections and infestations
Pneumonia
|
9.1%
1/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
2.5%
2/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
2.4%
2/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Infections and infestations
Respiratory tract infection
|
9.1%
1/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
1.2%
1/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
1.2%
1/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
6.2%
5/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
4.7%
4/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
2.4%
2/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
7.5%
6/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
5.9%
5/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
10.7%
9/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
5.0%
4/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
4.7%
4/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
6.0%
5/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
6.2%
5/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
7.1%
6/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
4.8%
4/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Investigations
Blood alkaline phosphatase increased
|
9.1%
1/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
7.5%
6/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
4.7%
4/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
4.8%
4/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Investigations
International normalised ratio increased
|
9.1%
1/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
2.5%
2/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
2.4%
2/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
1.2%
1/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
6.2%
5/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
3.5%
3/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
3.6%
3/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Investigations
Weight decreased
|
9.1%
1/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
8.8%
7/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
10.6%
9/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
7.1%
6/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Investigations
White blood cell count increased
|
9.1%
1/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
45.5%
5/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
27.5%
22/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
16.5%
14/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
25.0%
21/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Metabolism and nutrition disorders
Dehydration
|
27.3%
3/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
5.0%
4/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
5.9%
5/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
7.1%
6/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
9.1%
1/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
2.5%
2/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
4.7%
4/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
3.6%
3/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
9.1%
1/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
1.2%
1/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
1.2%
1/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
9.1%
1/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
2.4%
2/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
10.0%
8/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
9.4%
8/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
11.9%
10/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
6.2%
5/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
2.4%
2/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
3.6%
3/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
9.1%
1/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
1.2%
1/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
2.4%
2/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
2.4%
2/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.1%
1/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
5.0%
4/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
4.7%
4/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
6.0%
5/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
27.3%
3/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
7.5%
6/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
10.6%
9/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
10.7%
9/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
9.1%
1/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
2.5%
2/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
2.4%
2/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Musculoskeletal and connective tissue disorders
Muscle atrophy
|
9.1%
1/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
9.1%
1/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
6.2%
5/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
6.0%
5/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
9.1%
1/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
18.2%
2/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
2.4%
2/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
9.1%
1/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
3.8%
3/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
1.2%
1/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
6.0%
5/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
9.1%
1/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
3.8%
3/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
1.2%
1/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
7.1%
6/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Nervous system disorders
Dizziness
|
9.1%
1/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
8.8%
7/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
10.6%
9/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
15.5%
13/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Nervous system disorders
Dizziness postural
|
9.1%
1/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
1.2%
1/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Nervous system disorders
Dysgeusia
|
9.1%
1/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
7.5%
6/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
7.1%
6/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
9.5%
8/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Nervous system disorders
Headache
|
9.1%
1/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
5.0%
4/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
3.5%
3/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
7.1%
6/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Nervous system disorders
Neuropathy peripheral
|
18.2%
2/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
6.2%
5/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
8.2%
7/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
8.3%
7/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Nervous system disorders
Parosmia
|
9.1%
1/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
1.2%
1/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
1.2%
1/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
9.1%
1/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
5.0%
4/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
2.4%
2/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
3.6%
3/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Nervous system disorders
VIIth nerve paralysis
|
9.1%
1/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Psychiatric disorders
Agitation
|
9.1%
1/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Psychiatric disorders
Anger
|
9.1%
1/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Psychiatric disorders
Anxiety
|
27.3%
3/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
6.2%
5/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
5.9%
5/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
4.8%
4/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Psychiatric disorders
Depression
|
9.1%
1/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
2.5%
2/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
3.5%
3/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
3.6%
3/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Psychiatric disorders
Insomnia
|
45.5%
5/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
11.2%
9/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
5.9%
5/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
9.5%
8/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Psychiatric disorders
Mood swings
|
9.1%
1/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
6.2%
5/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
3.5%
3/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Renal and urinary disorders
Micturition urgency
|
9.1%
1/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
1.2%
1/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Renal and urinary disorders
Nocturia
|
9.1%
1/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
9.1%
1/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.1%
1/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
12.5%
10/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
11.8%
10/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
16.7%
14/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
12.5%
10/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
10.6%
9/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
13.1%
11/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
9.1%
1/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
3.5%
3/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
9.1%
1/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
3.8%
3/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
9.5%
8/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
9.1%
1/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
2.5%
2/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
2.4%
2/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
4.8%
4/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Respiratory, thoracic and mediastinal disorders
Throat tightness
|
9.1%
1/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
54.5%
6/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
26.2%
21/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
23.5%
20/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
26.2%
22/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
6.2%
5/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
2.4%
2/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
6.0%
5/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
9.1%
1/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
3.8%
3/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
2.4%
2/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
3.6%
3/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
5.0%
4/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
1.2%
1/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
3.6%
3/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Skin and subcutaneous tissue disorders
Rash
|
9.1%
1/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
3.8%
3/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
4.7%
4/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
3.6%
3/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
9.1%
1/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
9.1%
1/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
1.2%
1/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
2.4%
2/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
2.4%
2/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Skin and subcutaneous tissue disorders
Skin wrinkling
|
9.1%
1/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
9.1%
1/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
1.2%
1/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Vascular disorders
Flushing
|
18.2%
2/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
2.4%
2/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Vascular disorders
Hypotension
|
9.1%
1/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
3.8%
3/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
2.4%
2/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
4.8%
4/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
|
Vascular disorders
Peripheral coldness
|
9.1%
1/11 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/80 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/85 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
0.00%
0/84 • Randomization up to 33 months
Safety Analysis Set included all participants in the Full Analysis Set grouped for analyses with treatment assignments designated according to the actual study drug received.
|
Additional Information
Gilead Clinical Study Information Center
Gilead Sciences
Phone: 1-833-445-3230 (GILEAD-0)
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: * The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or * The study has been completed at all study sites for at least 2 years
- Publication restrictions are in place
Restriction type: OTHER