Trial Outcomes & Findings for A Randomized, Double-Blind, Placebo-Controlled Study of Idelalisib in Combination With Rituximab for Previously Treated Chronic Lymphocytic Leukemia (CLL) (NCT NCT01539512)
NCT ID: NCT01539512
Last Updated: 2019-05-14
Results Overview
Progression-free survival was defined as the interval from randomization to the earlier of the first documentation of definitive disease progression or death from any cause. Definitive disease progression was CLL progression based on standard criteria (other than lymphocytosis alone) as defined by the 2008 update of the International Workshop on CLL guidelines, ie, appearance of any new lesion; increase by ≥ 50% in the sum of the products of the perpendicular diameters of measured lymph nodes (SPD); new or ≥ 50% enlargement of liver or spleen; transformation to a more aggressive histology (eg, Richter's or prolymphocytic transformation); reduction in the number of blood cells (cytopenia) attributable to CLL.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
220 participants
Primary outcome timeframe
Up to 17 months
Results posted on
2019-05-14
Participant Flow
Participants were enrolled at a total of 53 study sites in the United States and Europe. The first participant was screened on 03 April 2012. The last study visit occurred on 20 April 2014.
Participant milestones
| Measure |
Idelalisib + Rituximab
Idelalisib 150 mg tablet administered orally twice daily plus rituximab (8 intravenous doses through Week 20: Day 1: 375 mg/m\^2, and 500 mg/m\^2 thereafter)
|
Placebo + Rituximab
Placebo to match idelalisib administered orally twice daily plus rituximab (8 intravenous doses through Week 20: Day 1: 375 mg/m\^2, and 500 mg/m\^2 thereafter)
|
|---|---|---|
|
Overall Study
STARTED
|
110
|
110
|
|
Overall Study
COMPLETED
|
87
|
97
|
|
Overall Study
NOT COMPLETED
|
23
|
13
|
Reasons for withdrawal
| Measure |
Idelalisib + Rituximab
Idelalisib 150 mg tablet administered orally twice daily plus rituximab (8 intravenous doses through Week 20: Day 1: 375 mg/m\^2, and 500 mg/m\^2 thereafter)
|
Placebo + Rituximab
Placebo to match idelalisib administered orally twice daily plus rituximab (8 intravenous doses through Week 20: Day 1: 375 mg/m\^2, and 500 mg/m\^2 thereafter)
|
|---|---|---|
|
Overall Study
Adverse Event
|
9
|
7
|
|
Overall Study
Physician Decision
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
12
|
5
|
|
Overall Study
Richter's Transformation
|
1
|
0
|
Baseline Characteristics
A Randomized, Double-Blind, Placebo-Controlled Study of Idelalisib in Combination With Rituximab for Previously Treated Chronic Lymphocytic Leukemia (CLL)
Baseline characteristics by cohort
| Measure |
Idelalisib + Rituximab
n=110 Participants
Idelalisib 150 mg tablet administered orally twice daily plus rituximab (8 intravenous doses through Week 20: Day 1: 375 mg/m\^2, and 500 mg/m\^2 thereafter)
|
Placebo + Rituximab
n=110 Participants
Placebo to match idelalisib administered orally twice daily plus rituximab (8 intravenous doses through Week 20: Day 1: 375 mg/m\^2, and 500 mg/m\^2 thereafter)
|
Total
n=220 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
71 years
STANDARD_DEVIATION 7.7 • n=5 Participants
|
70 years
STANDARD_DEVIATION 8.1 • n=7 Participants
|
71 years
STANDARD_DEVIATION 7.9 • n=5 Participants
|
|
Age, Customized
< 65 years
|
21 participants
n=5 Participants
|
27 participants
n=7 Participants
|
48 participants
n=5 Participants
|
|
Age, Customized
≥ 65 years
|
89 participants
n=5 Participants
|
83 participants
n=7 Participants
|
172 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
76 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
144 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
101 participants
n=5 Participants
|
102 participants
n=7 Participants
|
203 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Permitted
|
5 participants
n=5 Participants
|
7 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
100 participants
n=5 Participants
|
98 participants
n=7 Participants
|
198 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Region of Enrollment
France
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
7 participants
n=5 Participants
|
5 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
2 participants
n=5 Participants
|
5 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
18 participants
n=5 Participants
|
14 participants
n=7 Participants
|
32 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
80 participants
n=5 Participants
|
83 participants
n=7 Participants
|
163 participants
n=5 Participants
|
|
Karnofsky Performance Status
40
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Karnofsky Performance Status
50
|
3 participants
n=5 Participants
|
4 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Karnofsky Performance Status
60
|
6 participants
n=5 Participants
|
5 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
Karnofsky Performance Status
70
|
20 participants
n=5 Participants
|
13 participants
n=7 Participants
|
33 participants
n=5 Participants
|
|
Karnofsky Performance Status
80
|
42 participants
n=5 Participants
|
46 participants
n=7 Participants
|
88 participants
n=5 Participants
|
|
Karnofsky Performance Status
90
|
23 participants
n=5 Participants
|
28 participants
n=7 Participants
|
51 participants
n=5 Participants
|
|
Karnofsky Performance Status
100
|
15 participants
n=5 Participants
|
13 participants
n=7 Participants
|
28 participants
n=5 Participants
|
|
Time Since Diagnosis
|
108.3 months
STANDARD_DEVIATION 62.28 • n=5 Participants
|
106.4 months
STANDARD_DEVIATION 52.73 • n=7 Participants
|
107.4 months
STANDARD_DEVIATION 57.58 • n=5 Participants
|
|
Rai Stage at Screening
Rai Stage 0
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Rai Stage at Screening
Rai Stage 1
|
18 participants
n=5 Participants
|
19 participants
n=7 Participants
|
37 participants
n=5 Participants
|
|
Rai Stage at Screening
Rai Stage 2
|
16 participants
n=5 Participants
|
10 participants
n=7 Participants
|
26 participants
n=5 Participants
|
|
Rai Stage at Screening
Rai Stage 3
|
22 participants
n=5 Participants
|
18 participants
n=7 Participants
|
40 participants
n=5 Participants
|
|
Rai Stage at Screening
Rai Stage 4
|
48 participants
n=5 Participants
|
54 participants
n=7 Participants
|
102 participants
n=5 Participants
|
|
Rai Stage at Screening
Missing
|
6 participants
n=5 Participants
|
8 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Binet Stage at Screening
Binet Stage A
|
7 participants
n=5 Participants
|
4 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
Binet Stage at Screening
Binet Stage B
|
29 participants
n=5 Participants
|
32 participants
n=7 Participants
|
61 participants
n=5 Participants
|
|
Binet Stage at Screening
Binet Stage C
|
63 participants
n=5 Participants
|
60 participants
n=7 Participants
|
123 participants
n=5 Participants
|
|
Binet Stage at Screening
Missing
|
11 participants
n=5 Participants
|
14 participants
n=7 Participants
|
25 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 17 monthsPopulation: Intent-to-Treat (ITT) Analysis Set: randomized participants with treatment group designated according to initial randomization.
Progression-free survival was defined as the interval from randomization to the earlier of the first documentation of definitive disease progression or death from any cause. Definitive disease progression was CLL progression based on standard criteria (other than lymphocytosis alone) as defined by the 2008 update of the International Workshop on CLL guidelines, ie, appearance of any new lesion; increase by ≥ 50% in the sum of the products of the perpendicular diameters of measured lymph nodes (SPD); new or ≥ 50% enlargement of liver or spleen; transformation to a more aggressive histology (eg, Richter's or prolymphocytic transformation); reduction in the number of blood cells (cytopenia) attributable to CLL.
Outcome measures
| Measure |
Idelalisib + Rituximab
n=110 Participants
Idelalisib 150 mg tablet administered orally twice daily plus rituximab (8 intravenous doses through Week 20: Day 1: 375 mg/m\^2, and 500 mg/m\^2 thereafter)
|
Placebo + Rituximab
n=110 Participants
Placebo to match idelalisib administered orally twice daily plus rituximab (8 intravenous doses through Week 20: Day 1: 375 mg/m\^2, and 500 mg/m\^2 thereafter)
|
|---|---|---|
|
Progression-Free Survival
|
NA months
Interval 10.7 to
NA = Not reached due to insufficient number of events
|
5.5 months
Interval 3.8 to 7.1
|
SECONDARY outcome
Timeframe: Up to 17 monthsPopulation: ITT Analysis Set: randomized participants with treatment group designated according to initial randomization.
Overall response rate was defined as the percentage of participants who achieved a best overall response of complete response or partial response. Complete response was defined as no lymphadenopathy, hepatomegaly, splenomegaly; normal complete blood count; confirmed by bone marrow aspirate \& biopsy. Partial response 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.
Outcome measures
| Measure |
Idelalisib + Rituximab
n=110 Participants
Idelalisib 150 mg tablet administered orally twice daily plus rituximab (8 intravenous doses through Week 20: Day 1: 375 mg/m\^2, and 500 mg/m\^2 thereafter)
|
Placebo + Rituximab
n=110 Participants
Placebo to match idelalisib administered orally twice daily plus rituximab (8 intravenous doses through Week 20: Day 1: 375 mg/m\^2, and 500 mg/m\^2 thereafter)
|
|---|---|---|
|
Overall Response Rate
|
74.5 percentage of participants
Interval 65.4 to 82.4
|
14.5 percentage of participants
Interval 8.5 to 22.5
|
SECONDARY outcome
Timeframe: Up to 17 monthsPopulation: ITT Analysis Set: randomized participants with treatment group designated according to initial randomization
Lymph node response rate was defined as the percentage of participants who achieved a ≥ 50% decrease from baseline in the SPD of index lymph nodes.
Outcome measures
| Measure |
Idelalisib + Rituximab
n=110 Participants
Idelalisib 150 mg tablet administered orally twice daily plus rituximab (8 intravenous doses through Week 20: Day 1: 375 mg/m\^2, and 500 mg/m\^2 thereafter)
|
Placebo + Rituximab
n=110 Participants
Placebo to match idelalisib administered orally twice daily plus rituximab (8 intravenous doses through Week 20: Day 1: 375 mg/m\^2, and 500 mg/m\^2 thereafter)
|
|---|---|---|
|
Lymph Node Response Rate
|
92.2 percentage of participants
Interval 85.1 to 96.6
|
5.9 percentage of participants
Interval 2.2 to 12.5
|
SECONDARY outcome
Timeframe: Up to 17 monthsPopulation: ITT Analysis Set: randomized participants with treatment group designated according to initial randomization.
Overall survival was defined as the interval from randomization to death from any cause.
Outcome measures
| Measure |
Idelalisib + Rituximab
n=110 Participants
Idelalisib 150 mg tablet administered orally twice daily plus rituximab (8 intravenous doses through Week 20: Day 1: 375 mg/m\^2, and 500 mg/m\^2 thereafter)
|
Placebo + Rituximab
n=110 Participants
Placebo to match idelalisib administered orally twice daily plus rituximab (8 intravenous doses through Week 20: Day 1: 375 mg/m\^2, and 500 mg/m\^2 thereafter)
|
|---|---|---|
|
Overall Survival
|
NA months
NA = Not reached due to insufficient number of events
|
NA months
Interval 12.8 to
NA = Not reached due to insufficient number of events
|
SECONDARY outcome
Timeframe: Up to 17 monthsPopulation: ITT Analysis Set: randomized participants with treatment group designated according to initial randomization.
Complete response rate was defined as the percentage of participants who achieved a complete response.
Outcome measures
| Measure |
Idelalisib + Rituximab
n=110 Participants
Idelalisib 150 mg tablet administered orally twice daily plus rituximab (8 intravenous doses through Week 20: Day 1: 375 mg/m\^2, and 500 mg/m\^2 thereafter)
|
Placebo + Rituximab
n=110 Participants
Placebo to match idelalisib administered orally twice daily plus rituximab (8 intravenous doses through Week 20: Day 1: 375 mg/m\^2, and 500 mg/m\^2 thereafter)
|
|---|---|---|
|
Complete Response Rate
|
0 percentage of participants
|
0 percentage of participants
|
Adverse Events
Idelalisib + Rituximab
Serious events: 65 serious events
Other events: 103 other events
Deaths: 0 deaths
Placebo + Rituximab
Serious events: 43 serious events
Other events: 102 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Idelalisib + Rituximab
n=110 participants at risk
Idelalisib 150 mg tablet administered orally twice daily plus rituximab (8 intravenous doses through Week 20: Day 1: 375 mg/m\^2, and 500 mg/m\^2 thereafter)
|
Placebo + Rituximab
n=108 participants at risk
Placebo to match idelalisib administered orally twice daily plus rituximab (8 intravenous doses through Week 20: Day 1: 375 mg/m\^2, and 500 mg/m\^2 thereafter)
|
|---|---|---|
|
Nervous system disorders
Lethargy
|
0.91%
1/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
0.00%
0/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Nervous system disorders
Post herpetic neuralgia
|
0.91%
1/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
0.00%
0/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
0.93%
1/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Nervous system disorders
Syncope
|
0.00%
0/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
0.93%
1/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Nervous system disorders
Transient ischaemic attack
|
1.8%
2/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
0.00%
0/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Psychiatric disorders
Agitation
|
0.91%
1/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
0.00%
0/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Psychiatric disorders
Anxiety
|
0.91%
1/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
0.00%
0/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.91%
1/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
0.93%
1/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
4.5%
5/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
5.6%
6/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Blood and lymphatic system disorders
Haemolytic anaemia
|
0.91%
1/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
0.00%
0/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Blood and lymphatic system disorders
Neutropenia
|
2.7%
3/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
0.00%
0/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
0.93%
1/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Blood and lymphatic system disorders
Splenic infarction
|
0.00%
0/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
0.93%
1/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.91%
1/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
0.93%
1/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.91%
1/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
0.00%
0/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
0.93%
1/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.91%
1/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
0.00%
0/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Cardiac disorders
Left ventricular failure
|
0.00%
0/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
0.93%
1/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
0.93%
1/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Cardiac disorders
Right ventricular failure
|
0.91%
1/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
0.00%
0/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Endocrine disorders
Inappropriate antidiuretic hormone secretion
|
0.91%
1/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
0.00%
0/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Eye disorders
Eye pain
|
0.91%
1/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
0.00%
0/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.91%
1/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
0.93%
1/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Gastrointestinal disorders
Colitis
|
3.6%
4/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
0.00%
0/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Gastrointestinal disorders
Constipation
|
0.91%
1/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
0.93%
1/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Gastrointestinal disorders
Diarrhoea
|
7.3%
8/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
0.00%
0/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Gastrointestinal disorders
Gastric mucosa erythema
|
0.91%
1/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
0.00%
0/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Gastrointestinal disorders
Nausea
|
0.91%
1/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
0.00%
0/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Gastrointestinal disorders
Oral pain
|
0.91%
1/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
0.00%
0/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Gastrointestinal disorders
Vomiting
|
0.91%
1/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
0.00%
0/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
General disorders
Asthenia
|
1.8%
2/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
2.8%
3/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
General disorders
Chest pain
|
0.91%
1/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
0.00%
0/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
General disorders
Chills
|
0.00%
0/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
0.93%
1/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
General disorders
Device dislocation
|
0.91%
1/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
0.00%
0/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
General disorders
Fatigue
|
0.00%
0/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
0.93%
1/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
General disorders
General physical health deterioration
|
0.00%
0/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
0.93%
1/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
General disorders
Multi-organ failure
|
0.00%
0/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
0.93%
1/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
General disorders
Non-cardiac chest pain
|
0.91%
1/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
0.93%
1/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
General disorders
Oedema peripheral
|
0.00%
0/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
1.9%
2/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
General disorders
Pyrexia
|
9.1%
10/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
2.8%
3/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Infections and infestations
Abscess limb
|
0.00%
0/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
0.93%
1/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Infections and infestations
Alpha haemolytic streptococcal infection
|
0.91%
1/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
0.00%
0/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
0.93%
1/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Infections and infestations
Bronchitis
|
0.91%
1/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
0.93%
1/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Infections and infestations
Bronchopulmonary aspergillosis
|
0.91%
1/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
0.00%
0/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Infections and infestations
Cellulitis
|
0.91%
1/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
3.7%
4/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Infections and infestations
Diverticulitis
|
0.91%
1/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
0.00%
0/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Infections and infestations
Epididymitis
|
0.91%
1/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
0.00%
0/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Infections and infestations
Fungal oesophagitis
|
0.00%
0/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
0.93%
1/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Infections and infestations
Gastroenteritis
|
0.91%
1/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
0.93%
1/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
0.93%
1/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Infections and infestations
Herpes zoster disseminated
|
0.91%
1/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
0.00%
0/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Infections and infestations
Infection
|
0.91%
1/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
0.00%
0/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Infections and infestations
Listeriosis
|
0.00%
0/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
0.93%
1/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Infections and infestations
Lower respiratory tract infection
|
2.7%
3/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
0.93%
1/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Infections and infestations
Lung infection
|
2.7%
3/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
0.93%
1/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Infections and infestations
Mucosal infection
|
0.00%
0/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
0.93%
1/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Infections and infestations
Neutropenic sepsis
|
1.8%
2/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
0.00%
0/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Infections and infestations
Oral herpes
|
0.91%
1/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
0.00%
0/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
3.6%
4/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
0.93%
1/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Infections and infestations
Pneumonia
|
11.8%
13/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
9.3%
10/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Infections and infestations
Pneumonia fungal
|
1.8%
2/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
0.00%
0/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Infections and infestations
Pneumonia legionella
|
0.00%
0/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
0.93%
1/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Infections and infestations
Pneumonia pseudomonal
|
0.91%
1/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
0.00%
0/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
0.93%
1/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Infections and infestations
Sepsis
|
6.4%
7/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
2.8%
3/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Infections and infestations
Sepsis syndrome
|
1.8%
2/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
0.00%
0/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Infections and infestations
Septic shock
|
0.00%
0/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
1.9%
2/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
0.93%
1/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Infections and infestations
Stenotrophomonas infection
|
0.91%
1/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
0.00%
0/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.91%
1/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
1.9%
2/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Infections and infestations
Urinary tract infection
|
0.91%
1/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
0.93%
1/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Infections and infestations
Urosepsis
|
0.91%
1/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
0.00%
0/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
0.93%
1/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
0.93%
1/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.91%
1/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
1.9%
2/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
1.9%
2/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Investigations
International normalised ratio increased
|
0.00%
0/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
0.93%
1/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Investigations
Neutrophil count decreased
|
0.91%
1/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
0.00%
0/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Investigations
Transaminases increased
|
0.91%
1/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
0.00%
0/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Metabolism and nutrition disorders
Dehydration
|
2.7%
3/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
0.00%
0/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
1.8%
2/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
1.9%
2/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
0.93%
1/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.91%
1/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
0.00%
0/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.91%
1/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
0.00%
0/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
0.91%
1/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
0.93%
1/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.91%
1/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
0.00%
0/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.00%
0/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
0.93%
1/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
0.93%
1/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.91%
1/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
0.00%
0/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.00%
0/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
0.93%
1/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.91%
1/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
0.00%
0/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial carcinoma
|
0.91%
1/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
0.00%
0/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal squamous cell carcinoma
|
0.00%
0/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
0.93%
1/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.91%
1/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
0.00%
0/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Nervous system disorders
Amnesia
|
0.91%
1/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
0.00%
0/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.91%
1/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
0.00%
0/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Nervous system disorders
Convulsion
|
0.91%
1/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
0.00%
0/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Nervous system disorders
Headache
|
0.00%
0/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
0.93%
1/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Nervous system disorders
Iiird nerve disorder
|
0.00%
0/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
0.93%
1/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Psychiatric disorders
Confusional state
|
0.91%
1/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
0.00%
0/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
0.93%
1/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
0.93%
1/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Renal and urinary disorders
Renal failure acute
|
0.91%
1/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
0.00%
0/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.91%
1/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
0.93%
1/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.91%
1/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
0.93%
1/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
0.93%
1/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.8%
2/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
2.8%
3/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.91%
1/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
0.00%
0/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.8%
2/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
0.93%
1/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.8%
2/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
0.93%
1/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
3.6%
4/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
0.93%
1/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.91%
1/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
0.00%
0/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.91%
1/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
0.00%
0/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
1.9%
2/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.91%
1/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
0.00%
0/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Skin and subcutaneous tissue disorders
Dermatitis exfoliative
|
0.91%
1/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
0.00%
0/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
0.93%
1/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
0.93%
1/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.91%
1/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
0.00%
0/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.91%
1/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
0.00%
0/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Vascular disorders
Deep vein thrombosis
|
1.8%
2/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
0.00%
0/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Vascular disorders
Embolism
|
0.00%
0/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
0.93%
1/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Vascular disorders
Hypotension
|
1.8%
2/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
0.93%
1/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
Other adverse events
| Measure |
Idelalisib + Rituximab
n=110 participants at risk
Idelalisib 150 mg tablet administered orally twice daily plus rituximab (8 intravenous doses through Week 20: Day 1: 375 mg/m\^2, and 500 mg/m\^2 thereafter)
|
Placebo + Rituximab
n=108 participants at risk
Placebo to match idelalisib administered orally twice daily plus rituximab (8 intravenous doses through Week 20: Day 1: 375 mg/m\^2, and 500 mg/m\^2 thereafter)
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
11.8%
13/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
10.2%
11/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Blood and lymphatic system disorders
Neutropenia
|
25.5%
28/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
19.4%
21/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
7.3%
8/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
3.7%
4/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Gastrointestinal disorders
Abdominal distension
|
1.8%
2/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
5.6%
6/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Gastrointestinal disorders
Abdominal pain
|
8.2%
9/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
10.2%
11/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
7.3%
8/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
2.8%
3/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Gastrointestinal disorders
Colitis
|
5.5%
6/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
0.93%
1/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Gastrointestinal disorders
Constipation
|
14.5%
16/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
13.9%
15/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Gastrointestinal disorders
Diarrhoea
|
28.2%
31/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
17.6%
19/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
10.0%
11/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
0.00%
0/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Gastrointestinal disorders
Nausea
|
27.3%
30/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
23.1%
25/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Gastrointestinal disorders
Stomatitis
|
6.4%
7/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
0.93%
1/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Gastrointestinal disorders
Vomiting
|
14.5%
16/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
8.3%
9/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
General disorders
Asthenia
|
7.3%
8/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
7.4%
8/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
General disorders
Chills
|
24.5%
27/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
14.8%
16/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
General disorders
Fatigue
|
30.9%
34/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
32.4%
35/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
General disorders
Oedema peripheral
|
10.9%
12/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
9.3%
10/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
General disorders
Pain
|
7.3%
8/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
0.93%
1/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
General disorders
Pyrexia
|
36.4%
40/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
16.7%
18/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Infections and infestations
Bronchitis
|
6.4%
7/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
3.7%
4/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Infections and infestations
Cellulitis
|
6.4%
7/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
1.9%
2/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Infections and infestations
Pneumonia
|
3.6%
4/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
5.6%
6/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Infections and infestations
Sinusitis
|
8.2%
9/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
5.6%
6/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Infections and infestations
Upper respiratory tract infection
|
8.2%
9/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
12.0%
13/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Infections and infestations
Urinary tract infection
|
7.3%
8/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
3.7%
4/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
19.1%
21/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
30.6%
33/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Investigations
Alanine aminotransferase increased
|
7.3%
8/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
0.00%
0/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Investigations
Aspartate aminotransferase increased
|
7.3%
8/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
0.00%
0/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Investigations
Weight decreased
|
10.0%
11/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
8.3%
9/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
16.4%
18/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
11.1%
12/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
7.3%
8/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
5.6%
6/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.2%
9/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
3.7%
4/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.5%
6/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
3.7%
4/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
7.3%
8/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
6.5%
7/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Nervous system disorders
Dizziness
|
6.4%
7/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
8.3%
9/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Nervous system disorders
Headache
|
10.0%
11/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
8.3%
9/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Psychiatric disorders
Anxiety
|
2.7%
3/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
6.5%
7/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Psychiatric disorders
Insomnia
|
9.1%
10/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
6.5%
7/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
24.5%
27/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
31.5%
34/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
15.5%
17/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
20.4%
22/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
5.5%
6/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
3.7%
4/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.5%
6/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
5.6%
6/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
5.5%
6/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
3.7%
4/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
10.9%
12/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
12.0%
13/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.5%
6/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
4.6%
5/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Skin and subcutaneous tissue disorders
Rash
|
14.5%
16/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
3.7%
4/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
2.7%
3/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
6.5%
7/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
|
Vascular disorders
Hypotension
|
3.6%
4/110 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
6.5%
7/108 • During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
|
Additional Information
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