Trial Outcomes & Findings for Efficacy and Safety of Idelalisib in Combination With Bendamustine and Rituximab in Adults With Previously Untreated Chronic Lymphocytic Leukemia (NCT NCT01980888)
NCT ID: NCT01980888
Last Updated: 2018-11-19
Results Overview
Progression-free survival (PFS) is defined as the interval from randomization to the first documentation of definitive disease progression or death from any cause. Definitive disease progression is CLL progression based on standard criteria, excluding lymphocytosis alone. PFS was to be assessed by an independent review committee (IRC).
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
311 participants
Primary outcome timeframe
Up to 22 months
Results posted on
2018-11-19
Participant Flow
Participants were enrolled at study sites in the North America, Australia, and Europe. The first participant was screened on 05 February 2014. The last study visit occurred on 16 June 2016.
392 participants were screened.
Participant milestones
| Measure |
Idelalisib+Bendamustine+Rituximab
Idelalisib (Zydelig®) 150 mg tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m\^2 for up to 6 total cycles) + rituximab (375 mg/m\^2 on Day 1 and 500 mg/m\^2 thereafter for at total of 6 infusions)
|
Placebo+Bendamustine+Rituximab
Placebo tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m\^2 for up to 6 total cycles) + rituximab intravenously (375 mg/m\^2 on Day 1 and 500 mg/m\^2 thereafter for at total of 6 infusions)
|
|---|---|---|
|
Overall Study
STARTED
|
157
|
154
|
|
Overall Study
COMPLETED
|
13
|
21
|
|
Overall Study
NOT COMPLETED
|
144
|
133
|
Reasons for withdrawal
| Measure |
Idelalisib+Bendamustine+Rituximab
Idelalisib (Zydelig®) 150 mg tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m\^2 for up to 6 total cycles) + rituximab (375 mg/m\^2 on Day 1 and 500 mg/m\^2 thereafter for at total of 6 infusions)
|
Placebo+Bendamustine+Rituximab
Placebo tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m\^2 for up to 6 total cycles) + rituximab intravenously (375 mg/m\^2 on Day 1 and 500 mg/m\^2 thereafter for at total of 6 infusions)
|
|---|---|---|
|
Overall Study
Study Terminated by Sponsor
|
116
|
122
|
|
Overall Study
Withdrew Consent
|
17
|
6
|
|
Overall Study
Investigator's Discretion
|
8
|
3
|
|
Overall Study
Non-Compliance with Study Drug
|
3
|
2
|
Baseline Characteristics
Efficacy and Safety of Idelalisib in Combination With Bendamustine and Rituximab in Adults With Previously Untreated Chronic Lymphocytic Leukemia
Baseline characteristics by cohort
| Measure |
Idelalisib+Bendamustine+Rituximab
n=157 Participants
Idelalisib (Zydelig®) 150 mg tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m\^2 for up to 6 total cycles) + rituximab (375 mg/m\^2 on Day 1 and 500 mg/m\^2 thereafter for at total of 6 infusions)
|
Placebo+Bendamustine+Rituximab
n=154 Participants
Placebo tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m\^2 for up to 6 total cycles) + rituximab intravenously (375 mg/m\^2 on Day 1 and 500 mg/m\^2 thereafter for at total of 6 infusions)
|
Total
n=311 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64 years
STANDARD_DEVIATION 8.7 • n=5 Participants
|
63 years
STANDARD_DEVIATION 10.0 • n=7 Participants
|
64 years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
57 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
105 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
100 Participants
n=5 Participants
|
106 Participants
n=7 Participants
|
206 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
152 Participants
n=5 Participants
|
150 Participants
n=7 Participants
|
302 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Permitted
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
11 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
146 Participants
n=5 Participants
|
149 Participants
n=7 Participants
|
295 Participants
n=5 Participants
|
|
Region of Enrollment
Romania
|
4 participants
n=5 Participants
|
1 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Region of Enrollment
Hungary
|
24 participants
n=5 Participants
|
21 participants
n=7 Participants
|
45 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
35 participants
n=5 Participants
|
25 participants
n=7 Participants
|
60 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
7 participants
n=5 Participants
|
13 participants
n=7 Participants
|
20 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
19 participants
n=5 Participants
|
15 participants
n=7 Participants
|
34 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
11 participants
n=5 Participants
|
8 participants
n=7 Participants
|
19 participants
n=5 Participants
|
|
Region of Enrollment
Czech Republic
|
10 participants
n=5 Participants
|
17 participants
n=7 Participants
|
27 participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
15 participants
n=5 Participants
|
18 participants
n=7 Participants
|
33 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
5 participants
n=5 Participants
|
3 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
15 participants
n=5 Participants
|
19 participants
n=7 Participants
|
34 participants
n=5 Participants
|
|
Region of Enrollment
France
|
4 participants
n=5 Participants
|
5 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Region of Enrollment
Croatia
|
5 participants
n=5 Participants
|
6 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
Rai Stage at Screening
Stage I
|
28 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Rai Stage at Screening
Stage II
|
66 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
124 Participants
n=5 Participants
|
|
Rai Stage at Screening
Stage III
|
25 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Rai Stage at Screening
Stage IV
|
38 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
|
IgHV Mutation
Mutated
|
54 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
108 Participants
n=5 Participants
|
|
IgHV Mutation
Unmutated
|
102 Participants
n=5 Participants
|
100 Participants
n=7 Participants
|
202 Participants
n=5 Participants
|
|
IgHV Mutation
Missing
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
17p Deletion in CLL Cells
Absent
|
146 Participants
n=5 Participants
|
145 Participants
n=7 Participants
|
291 Participants
n=5 Participants
|
|
17p Deletion in CLL Cells
Present
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
17p Deletion in CLL Cells
Missing
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 22 monthsPopulation: Intent to Treat (ITT) analysis set: all participants who are randomized in the study with treatment group designated according to initial randomization. Due to early study termination, the prespecified efficacy analyses were not conducted. The PFS data presented are investigator assessments rather than IRC assessments.
Progression-free survival (PFS) is defined as the interval from randomization to the first documentation of definitive disease progression or death from any cause. Definitive disease progression is CLL progression based on standard criteria, excluding lymphocytosis alone. PFS was to be assessed by an independent review committee (IRC).
Outcome measures
| Measure |
Idelalisib+Bendamustine+Rituximab
n=157 Participants
Idelalisib (Zydelig®) 150 mg tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m\^2 for up to 6 total cycles) + rituximab (375 mg/m\^2 on Day 1 and 500 mg/m\^2 thereafter for at total of 6 infusions)
|
Placebo+Bendamustine+Rituximab
n=154 Participants
Placebo tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m\^2 for up to 6 total cycles) + rituximab intravenously (375 mg/m\^2 on Day 1 and 500 mg/m\^2 thereafter for at total of 6 infusions)
|
|---|---|---|
|
Progression-Free Survival
|
NA months
Interval 19.3 to
NA: not reached
|
NA months
Interval 19.6 to
NA: not reached
|
SECONDARY outcome
Timeframe: Up to 22 monthsPopulation: The study was terminated in agreement with the FDA due to urgent safety measures. Complete data were not collected for any participant.
Overall response rate (ORR) is defined as the proportion of participants who achieve a confirmed complete or partial response. ORR was to be assessed by an IRC.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 22 monthsPopulation: The study was terminated in agreement with the FDA due to urgent safety measures. Complete data were not collected for any participant.
Nodal response rate is defined as the proportion of participants who achieve a 50% decrease from baseline in the sum of the products of the greatest perpendicular diameters of index lesions. Nodal response rate was to be assessed by an IRC.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 22 monthsPopulation: The study was terminated in agreement with the FDA due to urgent safety measures. Complete data were not collected for any participant.
Complete response rate is defined as the proportion of participants who achieve a confirmed complete response. Complete response rate was to be assessed by an IRC.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 22 monthsPopulation: The study was terminated in agreement with the FDA due to urgent safety measures. Complete data were not collected for any participant.
Overall survival is defined as the interval from randomization to death from any cause. Overall survival was to be assessed by an IRC.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 22 monthsPopulation: The study was terminated in agreement with the FDA due to urgent safety measures. Complete data were not collected for any participant.
Minimal residual disease (MRD) negativity rate is defined as the proportion of participants with MRD \< 10\^-4 assessed by flow cytometry in bone marrow at Week 36 after therapy initiation or at least 12 weeks after the last dose of rituximab or bendamustine (whichever is later) for participants receiving the final dose of rituximab after the original scheduled date. MRD negativity rate was to be assessed by an IRC.
Outcome measures
Outcome data not reported
Adverse Events
Idelalisib+Bendamustine+Rituximab
Serious events: 113 serious events
Other events: 154 other events
Deaths: 0 deaths
Placebo+Bendamustine+Rituximab
Serious events: 68 serious events
Other events: 150 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Idelalisib+Bendamustine+Rituximab
n=156 participants at risk
Idelalisib (Zydelig®) 150 mg tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m\^2 for up to 6 total cycles) + rituximab (375 mg/m\^2 on Day 1 and 500 mg/m\^2 thereafter for at total of 6 infusions)
|
Placebo+Bendamustine+Rituximab
n=154 participants at risk
Placebo tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m\^2 for up to 6 total cycles) + rituximab intravenously (375 mg/m\^2 on Day 1 and 500 mg/m\^2 thereafter for at total of 6 infusions)
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
5.1%
8/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
1.3%
2/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Blood and lymphatic system disorders
Bone marrow failure
|
0.64%
1/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
0.00%
0/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
18.6%
29/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
10.4%
16/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Blood and lymphatic system disorders
Haemolytic anaemia
|
0.64%
1/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
0.00%
0/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Blood and lymphatic system disorders
Lymphadenopathy mediastinal
|
0.00%
0/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
0.65%
1/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Blood and lymphatic system disorders
Neutropenia
|
4.5%
7/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
0.65%
1/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.3%
2/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
0.65%
1/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
1.3%
2/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
0.65%
1/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Cardiac disorders
Atrial fibrillation
|
2.6%
4/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
1.9%
3/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Cardiac disorders
Cardiac failure
|
0.64%
1/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
1.3%
2/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Cardiac disorders
Cardiac failure chronic
|
0.00%
0/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
0.65%
1/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.64%
1/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
0.00%
0/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.64%
1/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
0.65%
1/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Cardiac disorders
Coronary artery disease
|
0.64%
1/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
0.00%
0/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
0.65%
1/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Cardiac disorders
Supraventricular extrasystoles
|
0.00%
0/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
0.65%
1/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
0.65%
1/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Endocrine disorders
Glucocorticoid deficiency
|
0.00%
0/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
0.65%
1/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Eye disorders
Blindness
|
0.64%
1/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
0.00%
0/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.64%
1/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
0.00%
0/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.64%
1/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
0.00%
0/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Gastrointestinal disorders
Diarrhoea
|
3.8%
6/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
0.65%
1/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Gastrointestinal disorders
Enterocolitis
|
1.3%
2/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
0.00%
0/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
0.65%
1/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
0.65%
1/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.64%
1/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
0.00%
0/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
0.65%
1/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
0.65%
1/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.64%
1/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
0.00%
0/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Gastrointestinal disorders
Vomiting
|
0.64%
1/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
0.65%
1/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
General disorders
Asthenia
|
0.64%
1/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
0.00%
0/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
General disorders
Chest pain
|
0.00%
0/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
0.65%
1/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
General disorders
Influenza like illness
|
0.64%
1/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
0.00%
0/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
General disorders
Mucosal inflammation
|
0.64%
1/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
0.00%
0/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
General disorders
Oedema peripheral
|
0.64%
1/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
0.00%
0/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
General disorders
Pyrexia
|
16.7%
26/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
12.3%
19/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
General disorders
Systemic inflammatory response syndrome
|
0.00%
0/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
0.65%
1/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
General disorders
Unevaluable event
|
0.00%
0/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
0.65%
1/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.64%
1/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
0.00%
0/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
0.65%
1/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Hepatobiliary disorders
Hepatitis
|
0.64%
1/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
0.00%
0/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Immune system disorders
Anaphylactic reaction
|
1.3%
2/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
0.00%
0/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
1.9%
3/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
0.65%
1/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Immune system disorders
Serum sickness
|
0.64%
1/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
0.00%
0/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Infections and infestations
Appendicitis
|
0.64%
1/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
0.00%
0/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Infections and infestations
Bronchitis
|
0.64%
1/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
0.00%
0/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Infections and infestations
Cellulitis
|
0.64%
1/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
0.65%
1/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Infections and infestations
Cytomegalovirus gastritis
|
0.64%
1/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
0.00%
0/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Infections and infestations
Cytomegalovirus infection
|
1.9%
3/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
0.00%
0/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Infections and infestations
Cytomegalovirus viraemia
|
0.64%
1/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
0.00%
0/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Infections and infestations
Device related infection
|
1.3%
2/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
0.00%
0/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Infections and infestations
Gastroenteritis
|
0.64%
1/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
0.00%
0/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Infections and infestations
Gastrointestinal bacterial infection
|
0.64%
1/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
0.00%
0/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Infections and infestations
Herpes simplex
|
0.64%
1/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
0.00%
0/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Infections and infestations
Herpes zoster
|
0.64%
1/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
0.00%
0/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Infections and infestations
Infective exacerbation of chronic obstructive airways disease
|
0.00%
0/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
0.65%
1/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Infections and infestations
Influenza
|
1.3%
2/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
0.00%
0/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Infections and infestations
Lower respiratory tract infection
|
1.3%
2/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
0.65%
1/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Infections and infestations
Myocarditis infectious
|
0.64%
1/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
0.00%
0/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Infections and infestations
Neutropenic sepsis
|
3.2%
5/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
0.65%
1/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.64%
1/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
0.00%
0/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Infections and infestations
Pneumonia
|
7.1%
11/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
3.9%
6/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Infections and infestations
Pneumonia fungal
|
0.64%
1/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
0.00%
0/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Infections and infestations
Respiratory tract infection
|
1.9%
3/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
0.65%
1/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Infections and infestations
Sepsis
|
5.8%
9/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
1.3%
2/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Infections and infestations
Septic shock
|
0.64%
1/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
0.00%
0/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.64%
1/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
0.00%
0/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Infections and infestations
Strongyloidiasis
|
0.00%
0/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
0.65%
1/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
0.65%
1/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.64%
1/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
0.65%
1/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Infections and infestations
Urinary tract infection
|
2.6%
4/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
0.65%
1/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Infections and infestations
Varicella zoster virus infection
|
0.64%
1/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
0.00%
0/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Infections and infestations
Viral infection
|
0.00%
0/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
0.65%
1/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
0.65%
1/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
0.65%
1/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
1.9%
3/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
0.65%
1/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Injury, poisoning and procedural complications
Procedural complication
|
0.00%
0/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
0.65%
1/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Investigations
Alanine aminotransferase increased
|
1.3%
2/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
0.00%
0/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Investigations
Aspartate aminotransferase increased
|
1.3%
2/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
0.00%
0/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Investigations
General physical condition abnormal
|
0.64%
1/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
0.00%
0/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Investigations
Transaminases increased
|
1.3%
2/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
0.00%
0/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.64%
1/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
0.00%
0/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.9%
3/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
0.65%
1/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
0.65%
1/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.64%
1/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
0.00%
0/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
3.2%
5/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
2.6%
4/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Compartment syndrome
|
0.64%
1/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
0.00%
0/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Diabetic amyotrophy
|
0.00%
0/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
0.65%
1/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
0.65%
1/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.00%
0/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
0.65%
1/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant ascites
|
0.00%
0/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
0.65%
1/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.64%
1/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
0.00%
0/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
0.00%
0/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
0.65%
1/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.64%
1/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
0.00%
0/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic squamous cell carcinoma
|
0.64%
1/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
0.00%
0/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin cancer
|
0.64%
1/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
0.00%
0/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.64%
1/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
0.00%
0/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of lung
|
0.00%
0/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
0.65%
1/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
0.65%
1/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Nervous system disorders
Encephalopathy
|
0.64%
1/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
0.00%
0/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Nervous system disorders
Facial paralysis
|
0.00%
0/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
0.65%
1/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
0.65%
1/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Nervous system disorders
Syncope
|
1.3%
2/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
0.00%
0/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Nervous system disorders
Transient ischaemic attack
|
1.3%
2/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
0.00%
0/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Psychiatric disorders
Anxiety
|
0.64%
1/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
0.00%
0/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Psychiatric disorders
Confusional state
|
0.64%
1/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
0.00%
0/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Psychiatric disorders
Depression
|
0.64%
1/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
0.00%
0/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Psychiatric disorders
Hallucination, auditory
|
0.64%
1/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
0.00%
0/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Psychiatric disorders
Mental status changes
|
0.64%
1/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
0.00%
0/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Renal and urinary disorders
Acute kidney injury
|
1.3%
2/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
0.00%
0/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Renal and urinary disorders
Prerenal failure
|
0.64%
1/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
0.00%
0/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Renal and urinary disorders
Renal tubular acidosis
|
0.64%
1/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
0.00%
0/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.64%
1/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
0.00%
0/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
0.65%
1/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.64%
1/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
0.00%
0/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
3.2%
5/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
1.9%
3/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Procedural pneumothorax
|
0.00%
0/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
0.65%
1/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
0.65%
1/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.64%
1/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
0.00%
0/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Skin and subcutaneous tissue disorders
Generalised erythema
|
1.3%
2/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
0.65%
1/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.00%
0/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
0.65%
1/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.6%
4/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
0.65%
1/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.64%
1/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
0.65%
1/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
1.3%
2/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
0.00%
0/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Vascular disorders
Aortitis
|
0.64%
1/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
0.00%
0/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Vascular disorders
Embolism
|
0.64%
1/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
0.00%
0/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Vascular disorders
Haematoma
|
0.64%
1/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
0.00%
0/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Vascular disorders
Peripheral embolism
|
0.64%
1/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
0.00%
0/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
0.65%
1/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.00%
0/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
0.65%
1/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Vascular disorders
Thrombosis
|
0.64%
1/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
0.00%
0/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
Other adverse events
| Measure |
Idelalisib+Bendamustine+Rituximab
n=156 participants at risk
Idelalisib (Zydelig®) 150 mg tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m\^2 for up to 6 total cycles) + rituximab (375 mg/m\^2 on Day 1 and 500 mg/m\^2 thereafter for at total of 6 infusions)
|
Placebo+Bendamustine+Rituximab
n=154 participants at risk
Placebo tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m\^2 for up to 6 total cycles) + rituximab intravenously (375 mg/m\^2 on Day 1 and 500 mg/m\^2 thereafter for at total of 6 infusions)
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
25.6%
40/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
18.8%
29/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Blood and lymphatic system disorders
Neutropenia
|
53.8%
84/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
58.4%
90/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
12.2%
19/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
10.4%
16/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Cardiac disorders
Atrial fibrillation
|
5.1%
8/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
1.9%
3/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Gastrointestinal disorders
Abdominal pain
|
9.0%
14/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
9.1%
14/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Gastrointestinal disorders
Constipation
|
16.7%
26/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
22.1%
34/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Gastrointestinal disorders
Diarrhoea
|
40.4%
63/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
29.9%
46/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Gastrointestinal disorders
Dry mouth
|
7.1%
11/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
2.6%
4/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Gastrointestinal disorders
Dyspepsia
|
9.6%
15/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
7.8%
12/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
5.8%
9/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
2.6%
4/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Gastrointestinal disorders
Nausea
|
39.1%
61/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
40.9%
63/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Gastrointestinal disorders
Stomatitis
|
6.4%
10/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
2.6%
4/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Gastrointestinal disorders
Vomiting
|
23.7%
37/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
14.9%
23/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
General disorders
Asthenia
|
13.5%
21/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
5.8%
9/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
General disorders
Chills
|
13.5%
21/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
9.1%
14/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
General disorders
Fatigue
|
27.6%
43/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
28.6%
44/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
General disorders
Mucosal inflammation
|
9.0%
14/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
0.65%
1/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
General disorders
Oedema peripheral
|
12.2%
19/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
10.4%
16/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
General disorders
Pyrexia
|
45.5%
71/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
24.7%
38/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Immune system disorders
Drug hypersensitivity
|
5.1%
8/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
1.3%
2/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Infections and infestations
Bronchitis
|
3.2%
5/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
5.2%
8/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Infections and infestations
Influenza
|
3.8%
6/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
5.2%
8/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Infections and infestations
Nasopharyngitis
|
5.1%
8/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
9.1%
14/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Infections and infestations
Oral candidiasis
|
5.1%
8/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
2.6%
4/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Infections and infestations
Oral herpes
|
3.2%
5/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
5.2%
8/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Infections and infestations
Pneumonia
|
6.4%
10/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
1.9%
3/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Infections and infestations
Respiratory tract infection
|
5.8%
9/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
2.6%
4/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Infections and infestations
Sinusitis
|
5.8%
9/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
2.6%
4/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Infections and infestations
Upper respiratory tract infection
|
16.0%
25/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
13.6%
21/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Infections and infestations
Urinary tract infection
|
9.6%
15/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
3.9%
6/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
13.5%
21/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
21.4%
33/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Investigations
Alanine aminotransferase increased
|
14.1%
22/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
1.9%
3/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Investigations
Aspartate aminotransferase increased
|
11.5%
18/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
1.3%
2/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Investigations
Neutrophil count decreased
|
5.1%
8/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
1.3%
2/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Investigations
Weight decreased
|
12.2%
19/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
2.6%
4/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
16.7%
26/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
13.6%
21/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Metabolism and nutrition disorders
Dehydration
|
7.7%
12/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
1.3%
2/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
16.0%
25/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
2.6%
4/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
5.8%
9/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
0.00%
0/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.3%
16/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
7.8%
12/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.1%
11/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
11.7%
18/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Nervous system disorders
Dizziness
|
8.3%
13/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
8.4%
13/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Nervous system disorders
Dysgeusia
|
6.4%
10/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
7.1%
11/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Nervous system disorders
Headache
|
10.3%
16/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
16.2%
25/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Psychiatric disorders
Anxiety
|
7.1%
11/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
5.8%
9/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Psychiatric disorders
Depression
|
5.1%
8/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
1.3%
2/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Psychiatric disorders
Insomnia
|
10.9%
17/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
7.8%
12/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Renal and urinary disorders
Dysuria
|
5.8%
9/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
1.9%
3/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
21.8%
34/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
18.8%
29/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
15.4%
24/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
7.8%
12/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.1%
8/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
5.8%
9/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
9.0%
14/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
2.6%
4/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
7.7%
12/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
5.2%
8/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
15.4%
24/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
20.8%
32/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Skin and subcutaneous tissue disorders
Rash
|
40.4%
63/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
22.1%
34/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
5.1%
8/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
1.3%
2/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
18.6%
29/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
7.8%
12/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
|
Vascular disorders
Hypotension
|
7.1%
11/156 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
|
6.5%
10/154 • Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, 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