Trial Outcomes & Findings for Efficacy and Safety of Idelalisib in Combination With Obinutuzumab Compared to Chlorambucil in Combination With Obinutuzumab for Previously Untreated Chronic Lymphocytic Leukemia (NCT NCT01980875)
NCT ID: NCT01980875
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
57 participants
Primary outcome timeframe
Up to 11 months
Results posted on
2018-11-19
Participant Flow
Participants were enrolled at study sites in Australia, Europe, and North America. The first participant was screened on 21 April 2015. The last study visit occurred on 13 May 2016.
80 participants were screened.
Participant milestones
| Measure |
Safety Run-In: Idelalisib+Obinutuzumab
Idelalisib (Zydelig®) 150 mg tablet twice daily + obinutuzumab 1000 mg/40 mL intravenously for a total of 8 doses over 21 weeks
|
Randomized: Idelalisib+Obinutuzumab
Idelalisib 150 mg tablet twice daily + obinutuzumab 1000 mg/40 mL intravenously for a total of 8 doses over 21 weeks
|
Randomized: Obinutuzumab+Chlorambucil
Chlorambucil 0.5 mg/kg, as 2 mg tablets every other week for a total of 12 doses + obinutuzumab 1000 mg/40 mL intravenously for a total of 8 doses over 21 weeks
|
|---|---|---|---|
|
Overall Study
STARTED
|
8
|
25
|
24
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
8
|
25
|
24
|
Reasons for withdrawal
| Measure |
Safety Run-In: Idelalisib+Obinutuzumab
Idelalisib (Zydelig®) 150 mg tablet twice daily + obinutuzumab 1000 mg/40 mL intravenously for a total of 8 doses over 21 weeks
|
Randomized: Idelalisib+Obinutuzumab
Idelalisib 150 mg tablet twice daily + obinutuzumab 1000 mg/40 mL intravenously for a total of 8 doses over 21 weeks
|
Randomized: Obinutuzumab+Chlorambucil
Chlorambucil 0.5 mg/kg, as 2 mg tablets every other week for a total of 12 doses + obinutuzumab 1000 mg/40 mL intravenously for a total of 8 doses over 21 weeks
|
|---|---|---|---|
|
Overall Study
Withdrew Consent
|
1
|
1
|
1
|
|
Overall Study
Study Terminated by Sponsor
|
7
|
24
|
22
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
Baseline Characteristics
Efficacy and Safety of Idelalisib in Combination With Obinutuzumab Compared to Chlorambucil in Combination With Obinutuzumab for Previously Untreated Chronic Lymphocytic Leukemia
Baseline characteristics by cohort
| Measure |
Safety Run-In: Idelalisib+Obinutuzumab
n=8 Participants
Idelalisib 150 mg tablet twice daily + obinutuzumab 1000 mg/40 mL intravenously for a total of 8 doses over 21 weeks
|
Randomized: Idelalisib+Obinutuzumab
n=25 Participants
Idelalisib 150 mg tablet twice daily + obinutuzumab 1000 mg/40 mL intravenously for a total of 8 doses over 21 weeks
|
Randomized: Obinutuzumab+Chlorambucil
n=24 Participants
Chlorambucil 0.5 mg/kg, as 2 mg tablets every other week for a total of 12 doses + obinutuzumab 1000 mg/40 mL intravenously for a total of 8 doses over 21 weeks
|
Total
n=57 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
67.1 years
STANDARD_DEVIATION 8.10 • n=5 Participants
|
72.2 years
STANDARD_DEVIATION 8.23 • n=7 Participants
|
71.1 years
STANDARD_DEVIATION 6.84 • n=5 Participants
|
71.1 years
STANDARD_DEVIATION 7.70 • n=4 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
7 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
50 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Not Permitted
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Region of Enrollment
Canada
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
2 participants
n=4 Participants
|
|
Region of Enrollment
Belgium
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
2 participants
n=4 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
3 participants
n=7 Participants
|
4 participants
n=5 Participants
|
12 participants
n=4 Participants
|
|
Region of Enrollment
Poland
|
2 participants
n=5 Participants
|
14 participants
n=7 Participants
|
12 participants
n=5 Participants
|
28 participants
n=4 Participants
|
|
Region of Enrollment
United Kingdom
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
3 participants
n=4 Participants
|
|
Region of Enrollment
France
|
0 participants
n=5 Participants
|
3 participants
n=7 Participants
|
2 participants
n=5 Participants
|
5 participants
n=4 Participants
|
|
Region of Enrollment
Australia
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
4 participants
n=4 Participants
|
|
Region of Enrollment
Spain
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Rai Stage
Stage I-II
|
3 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Rai Stage
Stage III-IV
|
5 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
|
IgHV Mutation
Unmutated
|
5 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
|
IgHV Mutation
Mutated
|
3 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
17p Deletion in CLL Cells
Present
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
17p Deletion in CLL Cells
Absent
|
8 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
51 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Up to 11 monthsPopulation: The study was terminated in agreement with the FDA due to urgent safety measures. Complete data were not collected for any participant.
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
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 11 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 11 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 11 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 11 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 11 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. For participants receiving the final dose of obinutuzumab after the original scheduled date, the MRD assessment was performed no less than 12 weeks after the last dose of obinutuzumab. MRD negativity rate was to be assessed by an IRC.
Outcome measures
Outcome data not reported
Adverse Events
Safety Run-In: Idelalisib+Obinutuzumab
Serious events: 2 serious events
Other events: 8 other events
Deaths: 0 deaths
Randomized: Idelalisib+Obinutuzumab
Serious events: 12 serious events
Other events: 19 other events
Deaths: 0 deaths
Randomized: Obinutuzumab+Chlorambucil
Serious events: 8 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Safety Run-In: Idelalisib+Obinutuzumab
n=8 participants at risk
Idelalisib 150 mg tablet twice daily + obinutuzumab 1000 mg/40 mL intravenously for a total of 8 doses over 21 weeks
|
Randomized: Idelalisib+Obinutuzumab
n=24 participants at risk
Idelalisib 150 mg tablet twice daily + obinutuzumab 1000 mg/40 mL intravenously for a total of 8 doses over 21 weeks
|
Randomized: Obinutuzumab+Chlorambucil
n=23 participants at risk
Chlorambucil 0.5 mg/kg, as 2 mg tablets every other week for a total of 12 doses + obinutuzumab 1000 mg/40 mL intravenously for a total of 8 doses over 21 weeks
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/8 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
8.3%
2/24 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
4.3%
1/23 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/8 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
4.2%
1/24 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
4.3%
1/23 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
|
Gastrointestinal disorders
Diarrhoea
|
12.5%
1/8 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
0.00%
0/24 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
0.00%
0/23 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/8 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
4.2%
1/24 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
0.00%
0/23 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
|
General disorders
Chills
|
0.00%
0/8 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
4.2%
1/24 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
0.00%
0/23 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
|
General disorders
Pyrexia
|
0.00%
0/8 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
4.2%
1/24 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
0.00%
0/23 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/8 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
0.00%
0/24 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
4.3%
1/23 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
|
Immune system disorders
Secondary immunodeficiency
|
0.00%
0/8 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
0.00%
0/24 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
4.3%
1/23 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
|
Infections and infestations
Bronchitis
|
0.00%
0/8 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
4.2%
1/24 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
0.00%
0/23 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/8 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
0.00%
0/24 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
4.3%
1/23 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/8 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
0.00%
0/24 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
4.3%
1/23 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
|
Infections and infestations
Lung infection
|
0.00%
0/8 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
4.2%
1/24 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
0.00%
0/23 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
|
Infections and infestations
Pneumonia
|
0.00%
0/8 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
0.00%
0/24 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
4.3%
1/23 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/8 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
0.00%
0/24 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
4.3%
1/23 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
|
Infections and infestations
Sepsis
|
0.00%
0/8 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
4.2%
1/24 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
4.3%
1/23 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/8 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
4.2%
1/24 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
0.00%
0/23 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/8 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
4.2%
1/24 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
0.00%
0/23 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
0.00%
0/8 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
0.00%
0/24 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
4.3%
1/23 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Richter's syndrome
|
0.00%
0/8 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
0.00%
0/24 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
4.3%
1/23 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
|
Nervous system disorders
Leukoencephalopathy
|
12.5%
1/8 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
0.00%
0/24 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
0.00%
0/23 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/8 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
4.2%
1/24 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
0.00%
0/23 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/8 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
8.3%
2/24 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
0.00%
0/23 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/8 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
4.2%
1/24 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
0.00%
0/23 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
|
Vascular disorders
Hypertension
|
0.00%
0/8 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
0.00%
0/24 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
4.3%
1/23 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
Other adverse events
| Measure |
Safety Run-In: Idelalisib+Obinutuzumab
n=8 participants at risk
Idelalisib 150 mg tablet twice daily + obinutuzumab 1000 mg/40 mL intravenously for a total of 8 doses over 21 weeks
|
Randomized: Idelalisib+Obinutuzumab
n=24 participants at risk
Idelalisib 150 mg tablet twice daily + obinutuzumab 1000 mg/40 mL intravenously for a total of 8 doses over 21 weeks
|
Randomized: Obinutuzumab+Chlorambucil
n=23 participants at risk
Chlorambucil 0.5 mg/kg, as 2 mg tablets every other week for a total of 12 doses + obinutuzumab 1000 mg/40 mL intravenously for a total of 8 doses over 21 weeks
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
25.0%
2/8 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
25.0%
6/24 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
8.7%
2/23 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
|
Blood and lymphatic system disorders
Neutropenia
|
50.0%
4/8 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
25.0%
6/24 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
39.1%
9/23 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
37.5%
3/8 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
8.3%
2/24 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
4.3%
1/23 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
|
Eye disorders
Dry eye
|
12.5%
1/8 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
0.00%
0/24 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
0.00%
0/23 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
|
Eye disorders
Eye swelling
|
12.5%
1/8 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
0.00%
0/24 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
0.00%
0/23 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
|
Gastrointestinal disorders
Abdominal pain
|
12.5%
1/8 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
4.2%
1/24 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
4.3%
1/23 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
|
Gastrointestinal disorders
Autoimmune colitis
|
12.5%
1/8 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
0.00%
0/24 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
0.00%
0/23 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
|
Gastrointestinal disorders
Constipation
|
25.0%
2/8 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
8.3%
2/24 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
4.3%
1/23 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
|
Gastrointestinal disorders
Diarrhoea
|
50.0%
4/8 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
16.7%
4/24 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
4.3%
1/23 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
|
Gastrointestinal disorders
Flatulence
|
12.5%
1/8 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
0.00%
0/24 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
0.00%
0/23 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
|
Gastrointestinal disorders
Nausea
|
25.0%
2/8 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
8.3%
2/24 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
17.4%
4/23 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
|
Gastrointestinal disorders
Stomatitis
|
12.5%
1/8 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
0.00%
0/24 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
0.00%
0/23 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
|
General disorders
Chills
|
12.5%
1/8 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
8.3%
2/24 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
0.00%
0/23 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
|
General disorders
Face oedema
|
12.5%
1/8 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
0.00%
0/24 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
0.00%
0/23 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
|
General disorders
Fatigue
|
12.5%
1/8 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
12.5%
3/24 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
8.7%
2/23 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
|
General disorders
Influenza like illness
|
25.0%
2/8 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
0.00%
0/24 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
0.00%
0/23 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
|
General disorders
Oedema peripheral
|
12.5%
1/8 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
12.5%
3/24 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
4.3%
1/23 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
|
General disorders
Pyrexia
|
12.5%
1/8 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
4.2%
1/24 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
17.4%
4/23 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
|
Infections and infestations
Acute sinusitis
|
12.5%
1/8 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
0.00%
0/24 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
0.00%
0/23 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
|
Infections and infestations
Clostridium difficile colitis
|
12.5%
1/8 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
0.00%
0/24 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
0.00%
0/23 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/8 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
0.00%
0/24 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
8.7%
2/23 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
|
Infections and infestations
Pneumonia
|
0.00%
0/8 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
8.3%
2/24 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
4.3%
1/23 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
|
Infections and infestations
Upper respiratory tract infection
|
12.5%
1/8 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
8.3%
2/24 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
8.7%
2/23 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
|
Infections and infestations
Urinary tract infection
|
12.5%
1/8 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
4.2%
1/24 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
0.00%
0/23 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
25.0%
2/8 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
12.5%
3/24 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
60.9%
14/23 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
|
Injury, poisoning and procedural complications
Muscle strain
|
12.5%
1/8 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
0.00%
0/24 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
0.00%
0/23 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
|
Investigations
Alanine aminotransferase increased
|
87.5%
7/8 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
20.8%
5/24 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
4.3%
1/23 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
|
Investigations
Aspartate aminotransferase increased
|
87.5%
7/8 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
20.8%
5/24 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
4.3%
1/23 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
|
Investigations
Blood creatinine increased
|
0.00%
0/8 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
8.3%
2/24 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
0.00%
0/23 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
|
Investigations
Heart rate increased
|
12.5%
1/8 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
0.00%
0/24 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
0.00%
0/23 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
12.5%
1/8 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
0.00%
0/24 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
4.3%
1/23 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
12.5%
1/8 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
4.2%
1/24 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
0.00%
0/23 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/8 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
12.5%
3/24 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
0.00%
0/23 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
12.5%
1/8 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
0.00%
0/24 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
0.00%
0/23 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
12.5%
1/8 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
8.3%
2/24 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
0.00%
0/23 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
12.5%
1/8 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
0.00%
0/24 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
0.00%
0/23 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
|
Metabolism and nutrition disorders
Tetany
|
0.00%
0/8 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
0.00%
0/24 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
8.7%
2/23 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
0.00%
0/8 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
0.00%
0/24 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
8.7%
2/23 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.5%
1/8 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
8.3%
2/24 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
0.00%
0/23 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/8 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
8.3%
2/24 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
4.3%
1/23 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
12.5%
1/8 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
0.00%
0/24 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
0.00%
0/23 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
|
Nervous system disorders
Cerebellar syndrome
|
12.5%
1/8 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
0.00%
0/24 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
0.00%
0/23 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
|
Nervous system disorders
Circadian rhythm sleep disorder
|
12.5%
1/8 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
0.00%
0/24 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
0.00%
0/23 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
|
Nervous system disorders
Dementia
|
12.5%
1/8 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
0.00%
0/24 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
0.00%
0/23 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
|
Nervous system disorders
Dizziness
|
12.5%
1/8 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
8.3%
2/24 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
0.00%
0/23 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
|
Nervous system disorders
Dizziness postural
|
12.5%
1/8 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
0.00%
0/24 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
0.00%
0/23 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
|
Nervous system disorders
Headache
|
12.5%
1/8 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
8.3%
2/24 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
8.7%
2/23 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
|
Nervous system disorders
Psychomotor skills impaired
|
12.5%
1/8 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
0.00%
0/24 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
0.00%
0/23 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
|
Nervous system disorders
Somnolence
|
12.5%
1/8 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
0.00%
0/24 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
0.00%
0/23 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
|
Nervous system disorders
Tremor
|
12.5%
1/8 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
0.00%
0/24 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
0.00%
0/23 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
|
Psychiatric disorders
Anxiety
|
12.5%
1/8 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
0.00%
0/24 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
4.3%
1/23 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
|
Psychiatric disorders
Insomnia
|
25.0%
2/8 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
8.3%
2/24 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
0.00%
0/23 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
|
Psychiatric disorders
Restlessness
|
25.0%
2/8 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
0.00%
0/24 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
0.00%
0/23 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/8 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
0.00%
0/24 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
8.7%
2/23 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
|
Renal and urinary disorders
Urinary retention
|
12.5%
1/8 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
0.00%
0/24 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
0.00%
0/23 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
|
Reproductive system and breast disorders
Penile pain
|
0.00%
0/8 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
8.3%
2/24 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
0.00%
0/23 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/8 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
8.3%
2/24 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
0.00%
0/23 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
12.5%
1/8 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
0.00%
0/24 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
0.00%
0/23 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
12.5%
1/8 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
0.00%
0/24 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
0.00%
0/23 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
12.5%
1/8 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
0.00%
0/24 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
0.00%
0/23 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
25.0%
2/8 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
0.00%
0/24 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
0.00%
0/23 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
|
Skin and subcutaneous tissue disorders
Rash
|
12.5%
1/8 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
4.2%
1/24 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
0.00%
0/23 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
12.5%
1/8 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
0.00%
0/24 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
0.00%
0/23 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
|
Vascular disorders
Flushing
|
12.5%
1/8 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
0.00%
0/24 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
4.3%
1/23 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
|
Vascular disorders
Hypertension
|
0.00%
0/8 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
8.3%
2/24 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
4.3%
1/23 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
|
Vascular disorders
Orthostatic hypotension
|
12.5%
1/8 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
0.00%
0/24 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
|
0.00%
0/23 • Baseline up to the last dose date plus 30 days (maximum: 12 months)
Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to 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