Trial Outcomes & Findings for Study Evaluating the Efficacy and Safety of Idelalisib in Combination With Bendamustine and Rituximab for Previously Treated Chronic Lymphocytic Leukemia (CLL) (Tugela ) (NCT NCT01569295)
NCT ID: NCT01569295
Last Updated: 2020-03-10
Results Overview
PFS was defined as the interval from randomization to the earlier of the first documentation of definitive disease progression or death from any cause. PFS (months) = (minimum (date of disease progression, date of death) - date of randomization + 1)/30.4375.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
416 participants
Primary outcome timeframe
Up to 84 months
Results posted on
2020-03-10
Participant Flow
Participants were enrolled at a total of 110 sites in Australia, New Zealand, Europe, Asia and North America. The first participant was screened on 15 June 2012. The last study visit occurred on 10 June 2019.
540 participants were screened.
Participant milestones
| Measure |
Idelalisib + Bendamustine + Rituximab
Idelalisib 150 mg tablet administered orally twice daily (until the earliest of participant withdrawal from study, definitive progression of chronic lymphocytic leukemia (CLL), intolerable toxicity, pregnancy, substantial noncompliance with study procedures, or study discontinuation) + rituximab 375 mg/m\^2 on Day 1, then 500 mg/m\^2 every 28 days administered intravenously for a total of 6 infusions + bendamustine 70 mg/mg\^2/infusion on days 1 and 2 of each 28 day cycle, administered intravenously for a total of 6 cycles (12 infusions).
|
Placebo + Bendamustine + Rituximab
Placebo to match idelalisib administered orally twice daily + rituximab 375 mg/m\^2 on Day 1, then 500 mg/ m\^2 every 28 days administered intravenously for a total of 6 infusions + bendamustine 70 mg/m\^2/infusion on days 1 and 2 of each 28 day cycle administered intravenously for a total of 6 cycles (12 infusions).
|
|---|---|---|
|
Overall Study
STARTED
|
207
|
209
|
|
Overall Study
Long-Term Follow-up
|
109
|
161
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
207
|
209
|
Reasons for withdrawal
| Measure |
Idelalisib + Bendamustine + Rituximab
Idelalisib 150 mg tablet administered orally twice daily (until the earliest of participant withdrawal from study, definitive progression of chronic lymphocytic leukemia (CLL), intolerable toxicity, pregnancy, substantial noncompliance with study procedures, or study discontinuation) + rituximab 375 mg/m\^2 on Day 1, then 500 mg/m\^2 every 28 days administered intravenously for a total of 6 infusions + bendamustine 70 mg/mg\^2/infusion on days 1 and 2 of each 28 day cycle, administered intravenously for a total of 6 cycles (12 infusions).
|
Placebo + Bendamustine + Rituximab
Placebo to match idelalisib administered orally twice daily + rituximab 375 mg/m\^2 on Day 1, then 500 mg/ m\^2 every 28 days administered intravenously for a total of 6 infusions + bendamustine 70 mg/m\^2/infusion on days 1 and 2 of each 28 day cycle administered intravenously for a total of 6 cycles (12 infusions).
|
|---|---|---|
|
Overall Study
Progressive Disease
|
75
|
139
|
|
Overall Study
Adverse Event
|
39
|
14
|
|
Overall Study
Withdrawal by Subject
|
25
|
12
|
|
Overall Study
Death
|
19
|
15
|
|
Overall Study
Physician Decision
|
13
|
18
|
|
Overall Study
Study Terminated by Sponsor
|
24
|
2
|
|
Overall Study
Other Reason not Specified
|
3
|
5
|
|
Overall Study
Non-Compliance with Study Drug
|
6
|
1
|
|
Overall Study
Other Anticancer/Experimental Therapy
|
2
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
Baseline Characteristics
Study Evaluating the Efficacy and Safety of Idelalisib in Combination With Bendamustine and Rituximab for Previously Treated Chronic Lymphocytic Leukemia (CLL) (Tugela )
Baseline characteristics by cohort
| Measure |
Idelalisib + Bendamustine + Rituximab
n=207 Participants
Idelalisib 150 mg tablet administered orally twice daily (until the earliest of participant withdrawal from study, definitive progression of CLL, intolerable toxicity, pregnancy, substantial noncompliance with study procedures, or study discontinuation) + rituximab 375 mg/m\^2 on Day 1, then 500 mg/m\^2 every 28 days administered intravenously for a total of 6 infusions + bendamustine 70 mg/mg\^2/infusion on days 1 and 2 of each 28 day cycle, administered intravenously for a total of 6 cycles (12 infusions).
|
Placebo + Bendamustine + Rituximab
n=209 Participants
Placebo to match idelalisib administered orally twice daily + rituximab 375 mg/m\^2 on Day 1, then 500 mg/ m\^2 every 28 days administered intravenously for a total of 6 infusions + bendamustine 70 mg/m\^2/infusion on days 1 and 2 of each 28 day cycle administered intravenously for a total of 6 cycles (12 infusions).
|
Total
n=416 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62 years
STANDARD_DEVIATION 9.2 • n=99 Participants
|
63 years
STANDARD_DEVIATION 9.8 • n=107 Participants
|
62 years
STANDARD_DEVIATION 9.5 • n=206 Participants
|
|
Sex: Female, Male
Female
|
47 Participants
n=99 Participants
|
53 Participants
n=107 Participants
|
100 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
160 Participants
n=99 Participants
|
156 Participants
n=107 Participants
|
316 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
187 Participants
n=99 Participants
|
190 Participants
n=107 Participants
|
377 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
6 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · Not Permitted
|
10 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Hispanic or Latino
|
4 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Not Hispanic or Latino
|
191 Participants
n=99 Participants
|
188 Participants
n=107 Participants
|
379 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Not Permitted
|
12 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Missing
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Region of Enrollment
Romania
|
5 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Region of Enrollment
Hungary
|
24 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
44 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
37 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
70 Participants
n=206 Participants
|
|
Region of Enrollment
Czechia
|
9 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Region of Enrollment
United Kingdom
|
27 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
56 Participants
n=206 Participants
|
|
Region of Enrollment
Portugal
|
1 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Region of Enrollment
Russia
|
22 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
36 Participants
n=206 Participants
|
|
Region of Enrollment
Spain
|
14 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
|
Region of Enrollment
Greece
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Region of Enrollment
Canada
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Region of Enrollment
Turkey
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Region of Enrollment
Belgium
|
3 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Region of Enrollment
Ireland
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Region of Enrollment
Poland
|
17 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
39 Participants
n=206 Participants
|
|
Region of Enrollment
Italy
|
10 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Region of Enrollment
Australia
|
8 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Region of Enrollment
France
|
13 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
|
Region of Enrollment
Croatia
|
5 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Region of Enrollment
New Zealand
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Up to 84 monthsPopulation: The intent-to-treat (ITT) Analysis Set included all participants randomised in the study regardless of whether study drug was administered and with treatment group designated according to initial randomisation.
PFS was defined as the interval from randomization to the earlier of the first documentation of definitive disease progression or death from any cause. PFS (months) = (minimum (date of disease progression, date of death) - date of randomization + 1)/30.4375.
Outcome measures
| Measure |
Idelalisib + Bendamustine + Rituximab
n=207 Participants
Idelalisib 150 mg tablet administered orally twice daily (until the earliest of participant withdrawal from study, definitive progression of chronic lymphocytic leukemia (CLL), intolerable toxicity, pregnancy, substantial noncompliance with study procedures, or study discontinuation) + rituximab 375 mg/m\^2 on Day 1, then 500 mg/m\^2 every 28 days administered intravenously for a total of 6 infusions + bendamustine 70 mg/mg\^2/infusion on days 1 and 2 of each 28 day cycle, administered intravenously for a total of 6 cycles (12 infusions).
|
Placebo + Bendamustine + Rituximab
n=209 Participants
Placebo to match idelalisib administered orally twice daily + rituximab 375 mg/m\^2 on Day 1, then 500 mg/ m\^2 every 28 days administered intravenously for a total of 6 infusions + bendamustine 70 mg/m\^2/infusion on days 1 and 2 of each 28 day cycle administered intravenously for a total of 6 cycles (12 infusions).
|
|---|---|---|
|
Progression-Free Survival (PFS)
|
21.8 months
Interval 16.5 to 27.8
|
11.1 months
Interval 8.9 to 11.1
|
SECONDARY outcome
Timeframe: Up to 84 monthsPopulation: Participants in the ITT Analysis Set were analyzed.
ORR was the percentage of participants who achieved a complete response (CR), CR with incomplete marrow recovery (CRi,) or partial response (PR) and maintained the response for at least 12 weeks. CR was defined as no lymphadenopathy, hepatomegaly, splenomegaly; normal complete blood count; confirmed by bone marrow aspirate \& biopsy. PR was defined as \>1 of the following criteria: a 50% decrease in peripheral blood lymphocytes, lymphadenopathy, liver size, spleen size; plus ≥ 1 of the following: ≥ 1500/μL absolute neutrophil count, \> 100000/μL platelets, \> 11.0 g/dL hemoglobin or 50% improvement for either of these parameters without transfusions or growth factors. CRi was defined as all criteria for CR met but with persistent anemia, thrombocytopenia, neutropenia or a hypocellular bone marrow.
Outcome measures
| Measure |
Idelalisib + Bendamustine + Rituximab
n=207 Participants
Idelalisib 150 mg tablet administered orally twice daily (until the earliest of participant withdrawal from study, definitive progression of chronic lymphocytic leukemia (CLL), intolerable toxicity, pregnancy, substantial noncompliance with study procedures, or study discontinuation) + rituximab 375 mg/m\^2 on Day 1, then 500 mg/m\^2 every 28 days administered intravenously for a total of 6 infusions + bendamustine 70 mg/mg\^2/infusion on days 1 and 2 of each 28 day cycle, administered intravenously for a total of 6 cycles (12 infusions).
|
Placebo + Bendamustine + Rituximab
n=209 Participants
Placebo to match idelalisib administered orally twice daily + rituximab 375 mg/m\^2 on Day 1, then 500 mg/ m\^2 every 28 days administered intravenously for a total of 6 infusions + bendamustine 70 mg/m\^2/infusion on days 1 and 2 of each 28 day cycle administered intravenously for a total of 6 cycles (12 infusions).
|
|---|---|---|
|
Overall Response Rate (ORR)
|
70.0 percentage of participants
Interval 63.3 to 76.2
|
45.5 percentage of participants
Interval 38.6 to 52.5
|
SECONDARY outcome
Timeframe: Up to 84 monthsPopulation: Participants in the ITT Analysis Set with available data were analyzed.
Lymph node response rate was defined as the percentage of participants who achieved a ≥ 50% decrease from baseline in the sum of the products of the greatest perpendicular diameters (SPD) of index lesions.
Outcome measures
| Measure |
Idelalisib + Bendamustine + Rituximab
n=192 Participants
Idelalisib 150 mg tablet administered orally twice daily (until the earliest of participant withdrawal from study, definitive progression of chronic lymphocytic leukemia (CLL), intolerable toxicity, pregnancy, substantial noncompliance with study procedures, or study discontinuation) + rituximab 375 mg/m\^2 on Day 1, then 500 mg/m\^2 every 28 days administered intravenously for a total of 6 infusions + bendamustine 70 mg/mg\^2/infusion on days 1 and 2 of each 28 day cycle, administered intravenously for a total of 6 cycles (12 infusions).
|
Placebo + Bendamustine + Rituximab
n=197 Participants
Placebo to match idelalisib administered orally twice daily + rituximab 375 mg/m\^2 on Day 1, then 500 mg/ m\^2 every 28 days administered intravenously for a total of 6 infusions + bendamustine 70 mg/m\^2/infusion on days 1 and 2 of each 28 day cycle administered intravenously for a total of 6 cycles (12 infusions).
|
|---|---|---|
|
Lymph Node Response Rate
|
96.9 percentage of particpants
Interval 93.3 to 98.8
|
60.9 percentage of particpants
Interval 53.7 to 67.8
|
SECONDARY outcome
Timeframe: Up to 84 monthsPopulation: Participants in the ITT Analysis Set were analyzed.
Overall survival (OS) was defined as the interval from randomization to death from any cause. Overall survival (months) = (date of death - date of randomization + 1)/30.4375.
Outcome measures
| Measure |
Idelalisib + Bendamustine + Rituximab
n=207 Participants
Idelalisib 150 mg tablet administered orally twice daily (until the earliest of participant withdrawal from study, definitive progression of chronic lymphocytic leukemia (CLL), intolerable toxicity, pregnancy, substantial noncompliance with study procedures, or study discontinuation) + rituximab 375 mg/m\^2 on Day 1, then 500 mg/m\^2 every 28 days administered intravenously for a total of 6 infusions + bendamustine 70 mg/mg\^2/infusion on days 1 and 2 of each 28 day cycle, administered intravenously for a total of 6 cycles (12 infusions).
|
Placebo + Bendamustine + Rituximab
n=209 Participants
Placebo to match idelalisib administered orally twice daily + rituximab 375 mg/m\^2 on Day 1, then 500 mg/ m\^2 every 28 days administered intravenously for a total of 6 infusions + bendamustine 70 mg/m\^2/infusion on days 1 and 2 of each 28 day cycle administered intravenously for a total of 6 cycles (12 infusions).
|
|---|---|---|
|
Overall Survival
|
56.2 months
Interval 40.1 to
Upper CI was not reached due to the low number of deaths by the time of study closure.
|
42.6 months
Interval 35.3 to 54.8
|
SECONDARY outcome
Timeframe: Up to 84 monthsPopulation: Participants in the ITT Analysis Set were analyzed.
Complete response (CR) rate was defined as the percentage of participants who achieved a CR.
Outcome measures
| Measure |
Idelalisib + Bendamustine + Rituximab
n=207 Participants
Idelalisib 150 mg tablet administered orally twice daily (until the earliest of participant withdrawal from study, definitive progression of chronic lymphocytic leukemia (CLL), intolerable toxicity, pregnancy, substantial noncompliance with study procedures, or study discontinuation) + rituximab 375 mg/m\^2 on Day 1, then 500 mg/m\^2 every 28 days administered intravenously for a total of 6 infusions + bendamustine 70 mg/mg\^2/infusion on days 1 and 2 of each 28 day cycle, administered intravenously for a total of 6 cycles (12 infusions).
|
Placebo + Bendamustine + Rituximab
n=209 Participants
Placebo to match idelalisib administered orally twice daily + rituximab 375 mg/m\^2 on Day 1, then 500 mg/ m\^2 every 28 days administered intravenously for a total of 6 infusions + bendamustine 70 mg/m\^2/infusion on days 1 and 2 of each 28 day cycle administered intravenously for a total of 6 cycles (12 infusions).
|
|---|---|---|
|
Complete Response Rate
|
4.3 percentage of participants
Interval 2.0 to 8.1
|
0.5 percentage of participants
Interval 0.0 to 2.6
|
Adverse Events
Idelalisib + Bendamustine + Rituximab
Serious events: 152 serious events
Other events: 199 other events
Deaths: 89 deaths
Placebo + Bendamustine + Rituximab
Serious events: 94 serious events
Other events: 196 other events
Deaths: 106 deaths
Serious adverse events
| Measure |
Idelalisib + Bendamustine + Rituximab
n=207 participants at risk
Idelalisib 150 mg tablet administered orally twice daily (until the earliest of participant withdrawal from study, definitive progression of CLL, intolerable toxicity, pregnancy, substantial noncompliance with study procedures, or study discontinuation) + rituximab 375 mg/m\^2 on Day 1, then 500 mg/m\^2 every 28 days administered intravenously for a total of 6 infusions + bendamustine 70 mg/mg\^2/infusion on days 1 and 2 of each 28 day cycle, administered intravenously for a total of 6 cycles (12 infusions).
|
Placebo + Bendamustine + Rituximab
n=209 participants at risk
Placebo to match idelalisib administered orally twice daily + rituximab 375 mg/m\^2 on Day 1, then 500 mg/ m\^2 every 28 days administered intravenously for a total of 6 infusions + bendamustine 70 mg/m\^2/infusion on days 1 and 2 of each 28 day cycle administered intravenously for a total of 6 cycles (12 infusions).
|
|---|---|---|
|
Nervous system disorders
Post herpetic neuralgia
|
0.00%
0/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.48%
1/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Nervous system disorders
Seizure
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Nervous system disorders
Syncope
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.48%
1/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Psychiatric disorders
Confusional state
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Psychiatric disorders
Delusion
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.48%
1/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Psychiatric disorders
Mood swings
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Psychiatric disorders
Panic attack
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Psychiatric disorders
Personality change
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.48%
1/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Renal and urinary disorders
Calculus urinary
|
0.00%
0/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.48%
1/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Renal and urinary disorders
Haematuria
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Renal and urinary disorders
Renal colic
|
0.97%
2/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.48%
1/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Reproductive system and breast disorders
Cervical polyp
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Reproductive system and breast disorders
Perineal necrosis
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.48%
1/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.48%
1/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.9%
4/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.96%
2/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.9%
4/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
1.4%
3/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.48%
1/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.97%
2/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.00%
0/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.48%
1/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.4%
3/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.9%
4/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.48%
1/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.97%
2/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
2.4%
5/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary pain
|
0.00%
0/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.48%
1/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.97%
2/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Skin and subcutaneous tissue disorders
Dermatitis exfoliative
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Skin and subcutaneous tissue disorders
Dermatitis exfoliative generalised
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Skin and subcutaneous tissue disorders
Drug reaction with eosinophilia and systemic symptoms
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Skin and subcutaneous tissue disorders
Stevens-Johnson syndrome
|
0.97%
2/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Vascular disorders
Deep vein thrombosis
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Vascular disorders
Hypotension
|
0.97%
2/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.96%
2/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Blood and lymphatic system disorders
Agranulocytosis
|
0.00%
0/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.96%
2/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Blood and lymphatic system disorders
Anaemia
|
3.9%
8/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
2.4%
5/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Blood and lymphatic system disorders
Autoimmune haemolytic anaemia
|
0.00%
0/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.96%
2/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
21.7%
45/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
4.8%
10/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Blood and lymphatic system disorders
Haemolytic anaemia
|
0.00%
0/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.48%
1/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Blood and lymphatic system disorders
Immune thrombocytopenic purpura
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.48%
1/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.48%
1/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Blood and lymphatic system disorders
Neutropenia
|
4.3%
9/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
1.4%
3/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.9%
4/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Blood and lymphatic system disorders
Thrombotic thrombocytopenic purpura
|
0.00%
0/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.48%
1/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.96%
2/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Cardiac disorders
Angina pectoris
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Cardiac disorders
Atrial fibrillation
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.48%
1/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Cardiac disorders
Cardiac arrest
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.48%
1/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.48%
1/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Cardiac disorders
Pericardial effusion
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Cardiac disorders
Supraventricular extrasystoles
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Eye disorders
Rhegmatogenous retinal detachment
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Eye disorders
Vision blurred
|
0.00%
0/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.48%
1/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.9%
4/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.96%
2/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.96%
2/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Gastrointestinal disorders
Colitis
|
2.4%
5/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.48%
1/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Gastrointestinal disorders
Colitis microscopic
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Gastrointestinal disorders
Constipation
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Gastrointestinal disorders
Diarrhoea
|
6.8%
14/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.48%
1/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Gastrointestinal disorders
Enterovesical fistula
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.48%
1/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Gastrointestinal disorders
Nausea
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.96%
2/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Gastrointestinal disorders
Neutropenic colitis
|
0.00%
0/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.48%
1/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.97%
2/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Gastrointestinal disorders
Pneumatosis intestinalis
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Gastrointestinal disorders
Pneumoperitoneum
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.96%
2/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
General disorders
Asthenia
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.96%
2/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
General disorders
Chest pain
|
0.00%
0/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.48%
1/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
General disorders
Chills
|
0.97%
2/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
General disorders
Fatigue
|
0.97%
2/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.96%
2/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
General disorders
General physical health deterioration
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.48%
1/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
General disorders
Malaise
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.48%
1/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
General disorders
Pyrexia
|
12.1%
25/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
5.3%
11/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.00%
0/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.48%
1/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Hepatobiliary disorders
Biliary fistula
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.48%
1/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.48%
1/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Hepatobiliary disorders
Hepatitis toxic
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Hepatobiliary disorders
Hepatocellular injury
|
0.97%
2/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Hepatobiliary disorders
Hepatotoxicity
|
0.00%
0/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.48%
1/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Immune system disorders
Drug hypersensitivity
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Immune system disorders
Haemophagocytic lymphohistiocytosis
|
0.00%
0/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.48%
1/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Immune system disorders
Hypersensitivity
|
0.97%
2/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Infections and infestations
Aspergillus infection
|
0.00%
0/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.48%
1/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.48%
1/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Infections and infestations
Bacterial sepsis
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Infections and infestations
Brain abscess
|
0.00%
0/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.48%
1/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Infections and infestations
Bronchitis
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
2.4%
5/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Infections and infestations
Bronchopulmonary aspergillosis
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Infections and infestations
Campylobacter gastroenteritis
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Infections and infestations
Cellulitis
|
1.9%
4/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.48%
1/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Infections and infestations
Conjunctivitis bacterial
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Infections and infestations
Cystitis
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Infections and infestations
Cytomegalovirus chorioretinitis
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.48%
1/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Infections and infestations
Cytomegalovirus colitis
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Infections and infestations
Cytomegalovirus enteritis
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Infections and infestations
Cytomegalovirus infection
|
1.4%
3/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.48%
1/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Infections and infestations
Cytomegalovirus viraemia
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Infections and infestations
Device related infection
|
0.97%
2/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.48%
1/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Infections and infestations
Diverticulitis
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Infections and infestations
Ecthyma
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Infections and infestations
Escherichia bacteraemia
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Infections and infestations
Escherichia sepsis
|
0.97%
2/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Infections and infestations
Eye infection toxoplasmal
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Infections and infestations
Fungal infection
|
0.00%
0/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.48%
1/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Infections and infestations
Gastroenteritis
|
0.97%
2/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Infections and infestations
Gastroenteritis cryptosporidial
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Infections and infestations
H1n1 influenza
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Infections and infestations
Haemophilus infection
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Infections and infestations
Herpes simplex
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Infections and infestations
Herpes zoster
|
1.9%
4/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.48%
1/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Infections and infestations
Human herpesvirus 6 infection
|
0.00%
0/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.48%
1/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Infections and infestations
Impetigo
|
0.00%
0/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.48%
1/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Infections and infestations
Influenza
|
1.4%
3/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.48%
1/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Infections and infestations
Lower respiratory tract infection
|
3.4%
7/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
2.4%
5/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Infections and infestations
Lower respiratory tract infection fungal
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Infections and infestations
Lung infection
|
0.00%
0/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
1.4%
3/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Infections and infestations
Meningitis aseptic
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Infections and infestations
Meningitis bacterial
|
0.00%
0/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.48%
1/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Infections and infestations
Meningitis enteroviral
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Infections and infestations
Neutropenic infection
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Infections and infestations
Neutropenic sepsis
|
1.4%
3/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
2.9%
6/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Infections and infestations
Ophthalmic herpes zoster
|
0.97%
2/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Infections and infestations
Oral herpes
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Infections and infestations
Oropharyngitis fungal
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Infections and infestations
Otitis externa
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Infections and infestations
Otitis media
|
0.00%
0/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.96%
2/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Infections and infestations
Perineal infection
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Infections and infestations
Pharyngeal abscess
|
0.00%
0/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.48%
1/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Infections and infestations
Pneumocystis jirovecii infection
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
1.4%
3/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Infections and infestations
Pneumonia
|
18.4%
38/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
7.7%
16/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.48%
1/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Infections and infestations
Pneumonia cytomegaloviral
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.48%
1/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Infections and infestations
Pneumonia pseudomonal
|
0.97%
2/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Infections and infestations
Pneumonia viral
|
0.00%
0/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.48%
1/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Infections and infestations
Pulmonary mycosis
|
0.00%
0/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.48%
1/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Infections and infestations
Pulmonary sepsis
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Infections and infestations
Respiratory tract infection
|
2.4%
5/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
2.4%
5/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Infections and infestations
Rhinovirus infection
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Infections and infestations
Sepsis
|
5.3%
11/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
1.9%
4/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Infections and infestations
Septic shock
|
2.4%
5/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.48%
1/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Infections and infestations
Sinusitis
|
0.97%
2/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Infections and infestations
Skin infection
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Infections and infestations
Soft tissue infection
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Infections and infestations
Tonsillitis
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Infections and infestations
Tuberculosis
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
1.9%
4/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Infections and infestations
Upper respiratory tract infection bacterial
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Infections and infestations
Urinary tract infection
|
3.4%
7/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
1.4%
3/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.00%
0/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.48%
1/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Infections and infestations
Urosepsis
|
0.97%
2/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.48%
1/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Infections and infestations
Viral infection
|
0.00%
0/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.48%
1/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Injury, poisoning and procedural complications
Eye injury
|
0.00%
0/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.48%
1/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.48%
1/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
1.4%
3/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Injury, poisoning and procedural complications
Periprosthetic fracture
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Investigations
Alanine aminotransferase increased
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Investigations
Anticoagulation drug level above therapeutic
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Investigations
Aspartate aminotransferase increased
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Investigations
Bk polyomavirus test positive
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Investigations
Blood creatinine increased
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.48%
1/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Investigations
Neutrophil count decreased
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Investigations
Streptococcus test positive
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Investigations
Transaminases increased
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Metabolism and nutrition disorders
Cachexia
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.48%
1/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.48%
1/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.48%
1/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.97%
2/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
1.4%
3/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.96%
2/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Chondritis
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Chondrocalcinosis
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Polyarthritis
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Reiter's syndrome
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute leukaemia
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.00%
0/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.96%
2/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
1.4%
3/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen's disease
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.00%
0/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.48%
1/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leiomyosarcoma
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lip squamous cell carcinoma
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.48%
1/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.97%
2/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
1.9%
4/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Nasopharyngeal cancer
|
0.00%
0/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.48%
1/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.97%
2/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal adenocarcinoma
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Salivary gland neoplasm
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
2.4%
5/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of lung
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
1.4%
3/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.96%
2/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
T-cell lymphoma
|
0.00%
0/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.48%
1/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Nervous system disorders
Dizziness
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Nervous system disorders
Headache
|
0.00%
0/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.48%
1/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Nervous system disorders
Ischaemic stroke
|
0.48%
1/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.00%
0/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
Other adverse events
| Measure |
Idelalisib + Bendamustine + Rituximab
n=207 participants at risk
Idelalisib 150 mg tablet administered orally twice daily (until the earliest of participant withdrawal from study, definitive progression of CLL, intolerable toxicity, pregnancy, substantial noncompliance with study procedures, or study discontinuation) + rituximab 375 mg/m\^2 on Day 1, then 500 mg/m\^2 every 28 days administered intravenously for a total of 6 infusions + bendamustine 70 mg/mg\^2/infusion on days 1 and 2 of each 28 day cycle, administered intravenously for a total of 6 cycles (12 infusions).
|
Placebo + Bendamustine + Rituximab
n=209 participants at risk
Placebo to match idelalisib administered orally twice daily + rituximab 375 mg/m\^2 on Day 1, then 500 mg/ m\^2 every 28 days administered intravenously for a total of 6 infusions + bendamustine 70 mg/m\^2/infusion on days 1 and 2 of each 28 day cycle administered intravenously for a total of 6 cycles (12 infusions).
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
26.1%
54/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
23.0%
48/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Blood and lymphatic system disorders
Leukopenia
|
8.2%
17/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
4.8%
10/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Blood and lymphatic system disorders
Neutropenia
|
62.3%
129/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
54.1%
113/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
19.8%
41/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
22.0%
46/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Gastrointestinal disorders
Abdominal pain
|
10.1%
21/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
6.2%
13/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Gastrointestinal disorders
Constipation
|
15.5%
32/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
16.7%
35/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Gastrointestinal disorders
Diarrhoea
|
43.0%
89/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
22.5%
47/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Gastrointestinal disorders
Dyspepsia
|
7.2%
15/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
3.8%
8/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Gastrointestinal disorders
Nausea
|
29.0%
60/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
34.4%
72/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Gastrointestinal disorders
Vomiting
|
16.9%
35/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
14.8%
31/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
General disorders
Asthenia
|
11.6%
24/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
9.6%
20/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
General disorders
Chills
|
10.6%
22/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
6.2%
13/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
General disorders
Fatigue
|
21.7%
45/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
24.9%
52/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
General disorders
Oedema peripheral
|
8.2%
17/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
8.6%
18/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
General disorders
Pyrexia
|
37.7%
78/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
26.3%
55/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Immune system disorders
Hypogammaglobulinaemia
|
5.8%
12/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
4.8%
10/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Infections and infestations
Bronchitis
|
9.7%
20/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
3.8%
8/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Infections and infestations
Herpes zoster
|
5.3%
11/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
2.9%
6/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Infections and infestations
Lower respiratory tract infection
|
6.3%
13/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
4.8%
10/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Infections and infestations
Nasopharyngitis
|
7.7%
16/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
5.3%
11/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Infections and infestations
Pneumonia
|
12.1%
25/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
6.2%
13/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Infections and infestations
Respiratory tract infection
|
3.4%
7/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
5.3%
11/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Infections and infestations
Sinusitis
|
9.2%
19/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
6.2%
13/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Infections and infestations
Upper respiratory tract infection
|
17.9%
37/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
10.0%
21/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
14.0%
29/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
21.5%
45/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Investigations
Alanine aminotransferase increased
|
15.5%
32/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.96%
2/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Investigations
Aspartate aminotransferase increased
|
9.2%
19/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
0.96%
2/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Investigations
Weight decreased
|
12.1%
25/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
5.7%
12/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
11.6%
24/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
7.2%
15/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
10.1%
21/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
7.7%
16/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
13.0%
27/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
7.7%
16/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.2%
17/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
7.2%
15/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Nervous system disorders
Headache
|
9.7%
20/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
10.0%
21/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Psychiatric disorders
Anxiety
|
2.9%
6/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
5.7%
12/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Psychiatric disorders
Insomnia
|
9.2%
19/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
6.2%
13/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.1%
52/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
22.5%
47/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
9.7%
20/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
12.4%
26/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
4.8%
10/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
6.7%
14/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
8.2%
17/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
5.7%
12/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
8.7%
18/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
3.8%
8/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.2%
17/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
5.7%
12/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Skin and subcutaneous tissue disorders
Rash
|
17.4%
36/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
13.4%
28/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Vascular disorders
Hypertension
|
6.3%
13/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
2.4%
5/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
|
Vascular disorders
Hypotension
|
6.8%
14/207 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.
|
6.2%
13/209 • First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
The Safety Analysis Set included all participants who received \>=1 dose of study treatment, with treatment group assignments designated according to the actual treatment 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