Trial Outcomes & Findings for Efficacy and Safety of Idelalisib (GS-1101) in Combination With Rituximab for Previously Treated Indolent Non-Hodgkin Lymphomas (NCT NCT01732913)
NCT ID: NCT01732913
Last Updated: 2018-11-16
Results Overview
Progression-free survival (PFS) is defined as the interval from randomization to the earlier of the first documentation of definitive indolent non-Hodgkin lymphoma (iNHL) disease progression or death from any cause. PFS was to be assessed by an independent review committee (IRC).
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
295 participants
Results posted on
2018-11-16
Participant Flow
Participants were enrolled at study sites in the North America, Europe, and Asia Pacific. The first participant was screened on 16 January 2013. The last study visit occurred on 18 May 2016.
385 participants were screened.
Participant milestones
| Measure |
Idelalisib + Rituximab
Idelalisib (Zydelig®) 150 mg tablet orally twice daily + rituximab 375 mg/m\^2 intravenously starting on Day 1 for a total of 8 infusions
|
Placebo + Rituximab
Placebo tablet orally twice daily + rituximab 375 mg/m\^2 intravenously starting on Day 1 for a total of 8 infusions
|
|---|---|---|
|
Overall Study
STARTED
|
198
|
97
|
|
Overall Study
COMPLETED
|
42
|
28
|
|
Overall Study
NOT COMPLETED
|
156
|
69
|
Reasons for withdrawal
| Measure |
Idelalisib + Rituximab
Idelalisib (Zydelig®) 150 mg tablet orally twice daily + rituximab 375 mg/m\^2 intravenously starting on Day 1 for a total of 8 infusions
|
Placebo + Rituximab
Placebo tablet orally twice daily + rituximab 375 mg/m\^2 intravenously starting on Day 1 for a total of 8 infusions
|
|---|---|---|
|
Overall Study
Study Terminated by Sponsor
|
105
|
55
|
|
Overall Study
Withdrawal by Subject
|
27
|
4
|
|
Overall Study
Physician Decision
|
14
|
7
|
|
Overall Study
Other
|
7
|
1
|
|
Overall Study
Initiation of Other Anti-Cancer Therapy
|
3
|
2
|
Baseline Characteristics
Efficacy and Safety of Idelalisib (GS-1101) in Combination With Rituximab for Previously Treated Indolent Non-Hodgkin Lymphomas
Baseline characteristics by cohort
| Measure |
Idelalisib + Rituximab
n=198 Participants
Idelalisib 150 mg tablet orally twice daily + rituximab 375 mg/m\^2 intravenously starting on Day 1 for a total of 8 infusions
|
Placebo + Rituximab
n=97 Participants
Placebo tablet orally twice daily + rituximab 375 mg/m\^2 intravenously starting on Day 1 for a total of 8 infusions
|
Total
n=295 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64 years
STANDARD_DEVIATION 11.4 • n=5 Participants
|
67 years
STANDARD_DEVIATION 11.4 • n=7 Participants
|
65 years
STANDARD_DEVIATION 11.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
99 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
147 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
99 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
148 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
35 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
123 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
177 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Permitted
|
32 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
12 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
150 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
225 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
36 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Region of Enrollment
Russian Federation
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
Singapore
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
Romania
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
Hungary
|
24 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
65 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
99 Participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
23 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
Portugal
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
6 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
Czech Republic
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
Sweden
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
Taiwan
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Region of Enrollment
Korea, Republic of
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Region of Enrollment
Israel
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Region of Enrollment
France
|
25 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Population: Due to the early termination of the study, efficacy data were not available for all participants, and therefore the prespecified analyses were not conducted.
Progression-free survival (PFS) is defined as the interval from randomization to the earlier of the first documentation of definitive indolent non-Hodgkin lymphoma (iNHL) disease progression or death from any cause. PFS was to be assessed by an independent review committee (IRC).
Outcome measures
Outcome data not reported
SECONDARY outcome
Population: Due to the early termination of the study, efficacy data were not available for all participants, and therefore the prespecified analyses were not conducted.
Overall Response Rate (ORR) is defined as the proportion of participants who achieve a complete response or partial response (or very good partial response or minor response for participants with Waldenstrom's). ORR was to be assessed by an IRC.
Outcome measures
Outcome data not reported
SECONDARY outcome
Population: Due to the early termination of the study, efficacy data were not available for all participants, and therefore the prespecified analyses were not conducted.
Lymph node response rate is defined as the proportion of participants who achieve ≥ 50% decrease from baseline in the sum of the products of the greatest perpendicular diameters of index lesions. Lymph node response rate was to be assessed by an IRC.
Outcome measures
Outcome data not reported
SECONDARY outcome
Population: Due to the early termination of the study, efficacy data were not available for all participants, and therefore the prespecified analyses were not conducted.
Complete response rate is defined as the proportion of participants who achieve a complete response. Complete response rate was to be assessed by an IRC.
Outcome measures
Outcome data not reported
SECONDARY outcome
Population: Due to the early termination of the study, efficacy data were not mature for all participants, and therefore the prespecified analyses were not conducted.
Overall survival is defined as the interval from randomization to death from any cause.
Outcome measures
Outcome data not reported
Adverse Events
Idelalisib + Rituximab
Serious events: 103 serious events
Other events: 189 other events
Deaths: 0 deaths
Placebo + Rituximab
Serious events: 11 serious events
Other events: 83 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Idelalisib + Rituximab
n=198 participants at risk
Idelalisib 150 mg tablet orally twice daily + rituximab 375 mg/m\^2 intravenously starting on Day 1 for a total of 8 infusions
|
Placebo + Rituximab
n=95 participants at risk
Placebo tablet orally twice daily + rituximab 375 mg/m\^2 intravenously starting on Day 1 for a total of 8 infusions
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.51%
1/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
0.00%
0/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
3.5%
7/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
0.00%
0/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.51%
1/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
0.00%
0/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.5%
3/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
0.00%
0/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.51%
1/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
1.1%
1/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Cardiac disorders
Acute coronary syndrome
|
0.51%
1/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
0.00%
0/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Cardiac disorders
Atrial fibrillation
|
0.51%
1/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
0.00%
0/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
1.1%
1/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Cardiac disorders
Cardiac arrest
|
0.51%
1/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
0.00%
0/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Cardiac disorders
Cardiac failure congestive
|
0.51%
1/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
2.1%
2/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Cardiac disorders
Pericarditis
|
0.51%
1/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
0.00%
0/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Cardiac disorders
Tachycardia
|
0.51%
1/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
0.00%
0/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Abdominal pain
|
0.51%
1/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
0.00%
0/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Colitis
|
4.0%
8/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
0.00%
0/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.51%
1/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
0.00%
0/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Constipation
|
0.51%
1/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
0.00%
0/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Diarrhoea
|
9.1%
18/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
0.00%
0/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Enteritis
|
0.51%
1/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
0.00%
0/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Enterocolitis
|
0.51%
1/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
0.00%
0/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Incarcerated inguinal hernia
|
0.51%
1/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
0.00%
0/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
1.1%
1/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Nausea
|
0.51%
1/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
0.00%
0/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Pancreatitis
|
0.51%
1/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
0.00%
0/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Salivary gland disorder
|
0.00%
0/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
1.1%
1/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Salivary gland enlargement
|
0.00%
0/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
1.1%
1/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Stomatitis
|
0.51%
1/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
0.00%
0/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Vomiting
|
1.5%
3/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
0.00%
0/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
General disorders
Asthenia
|
1.0%
2/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
0.00%
0/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
General disorders
Death
|
0.51%
1/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
0.00%
0/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
General disorders
Fatigue
|
0.51%
1/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
1.1%
1/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
General disorders
Gait disturbance
|
0.51%
1/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
0.00%
0/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
General disorders
Oedema
|
0.51%
1/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
0.00%
0/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
General disorders
Pyrexia
|
4.5%
9/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
1.1%
1/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.51%
1/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
0.00%
0/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
1.5%
3/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
0.00%
0/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Hepatobiliary disorders
Hepatic failure
|
0.51%
1/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
0.00%
0/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
1.0%
2/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
0.00%
0/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Hepatobiliary disorders
Jaundice
|
1.0%
2/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
0.00%
0/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Immune system disorders
Hypersensitivity
|
0.51%
1/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
0.00%
0/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Bronchitis
|
0.51%
1/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
0.00%
0/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Cellulitis
|
0.51%
1/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
0.00%
0/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Clostridium difficile colitis
|
0.51%
1/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
0.00%
0/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Cytomegalovirus infection
|
1.0%
2/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
0.00%
0/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Eczema herpeticum
|
0.51%
1/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
0.00%
0/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Fungaemia
|
0.51%
1/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
0.00%
0/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Gastroenteritis
|
0.51%
1/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
0.00%
0/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Herpes zoster meningomyelitis
|
0.51%
1/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
0.00%
0/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Infection
|
0.51%
1/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
1.1%
1/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Infective exacerbation of chronic obstructive airways disease
|
0.51%
1/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
0.00%
0/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
1.1%
1/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Metapneumovirus infection
|
0.00%
0/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
1.1%
1/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Neutropenic sepsis
|
0.51%
1/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
0.00%
0/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Otitis externa
|
0.51%
1/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
0.00%
0/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.51%
1/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
0.00%
0/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Pneumonia
|
9.6%
19/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
0.00%
0/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Sepsis
|
2.5%
5/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
0.00%
0/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Septic shock
|
0.51%
1/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
0.00%
0/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Skin bacterial infection
|
0.51%
1/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
0.00%
0/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.51%
1/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
0.00%
0/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Upper respiratory tract infection
|
1.0%
2/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
0.00%
0/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Urinary tract infection
|
2.0%
4/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
0.00%
0/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.51%
1/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
0.00%
0/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Fall
|
0.51%
1/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
0.00%
0/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.51%
1/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
2.1%
2/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Laceration
|
0.51%
1/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
0.00%
0/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.51%
1/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
0.00%
0/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.51%
1/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
0.00%
0/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.51%
1/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
0.00%
0/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.51%
1/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
0.00%
0/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
1.1%
1/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Investigations
Alanine aminotransferase increased
|
5.6%
11/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
0.00%
0/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Investigations
Aspartate aminotransferase increased
|
5.1%
10/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
0.00%
0/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
1.1%
1/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Investigations
Blood creatinine increased
|
0.51%
1/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
0.00%
0/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.51%
1/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
0.00%
0/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Investigations
Transaminases increased
|
0.51%
1/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
0.00%
0/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Metabolism and nutrition disorders
Cachexia
|
0.51%
1/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
0.00%
0/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Metabolism and nutrition disorders
Dehydration
|
2.0%
4/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
0.00%
0/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.51%
1/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
0.00%
0/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.51%
1/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
0.00%
0/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.51%
1/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
0.00%
0/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
1.0%
2/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
0.00%
0/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.0%
2/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
0.00%
0/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.51%
1/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
0.00%
0/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer recurrent
|
0.00%
0/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
1.1%
1/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma
|
0.51%
1/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
0.00%
0/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Nervous system disorders
Cerebrovascular accident
|
1.0%
2/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
0.00%
0/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Nervous system disorders
Dizziness
|
1.0%
2/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
0.00%
0/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Nervous system disorders
Syncope
|
1.5%
3/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
0.00%
0/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Nervous system disorders
Transient ischaemic attack
|
1.5%
3/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
0.00%
0/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Psychiatric disorders
Anxiety
|
0.51%
1/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
0.00%
0/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Psychiatric disorders
Major depression
|
0.51%
1/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
0.00%
0/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Psychiatric disorders
Mental status changes
|
1.0%
2/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
0.00%
0/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Psychiatric disorders
Suicidal ideation
|
0.51%
1/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
0.00%
0/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Renal and urinary disorders
Acute kidney injury
|
2.5%
5/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
0.00%
0/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.51%
1/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
0.00%
0/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Renal and urinary disorders
Urinary retention
|
0.51%
1/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
0.00%
0/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
|
0.51%
1/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
0.00%
0/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.0%
2/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
0.00%
0/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.51%
1/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
0.00%
0/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.5%
3/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
0.00%
0/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.51%
1/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
0.00%
0/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.0%
2/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
0.00%
0/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.51%
1/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
0.00%
0/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
1.0%
2/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
0.00%
0/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
4.0%
8/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
0.00%
0/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.5%
3/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
0.00%
0/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.51%
1/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
0.00%
0/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
1.0%
2/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
0.00%
0/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.0%
4/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
0.00%
0/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
Other adverse events
| Measure |
Idelalisib + Rituximab
n=198 participants at risk
Idelalisib 150 mg tablet orally twice daily + rituximab 375 mg/m\^2 intravenously starting on Day 1 for a total of 8 infusions
|
Placebo + Rituximab
n=95 participants at risk
Placebo tablet orally twice daily + rituximab 375 mg/m\^2 intravenously starting on Day 1 for a total of 8 infusions
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
6.1%
12/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
6.3%
6/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Blood and lymphatic system disorders
Neutropenia
|
12.6%
25/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
5.3%
5/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Abdominal pain
|
10.1%
20/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
4.2%
4/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Constipation
|
14.1%
28/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
13.7%
13/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Diarrhoea
|
44.4%
88/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
18.9%
18/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
5.1%
10/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
3.2%
3/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Nausea
|
25.3%
50/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
12.6%
12/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Vomiting
|
14.6%
29/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
7.4%
7/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
General disorders
Asthenia
|
7.6%
15/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
9.5%
9/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
General disorders
Chills
|
5.6%
11/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
4.2%
4/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
General disorders
Fatigue
|
20.7%
41/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
21.1%
20/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
General disorders
Oedema peripheral
|
7.1%
14/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
5.3%
5/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
General disorders
Pyrexia
|
25.3%
50/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
11.6%
11/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Bronchitis
|
4.5%
9/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
6.3%
6/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Nasopharyngitis
|
5.1%
10/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
6.3%
6/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Upper respiratory tract infection
|
11.6%
23/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
8.4%
8/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Urinary tract infection
|
6.6%
13/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
3.2%
3/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
18.2%
36/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
21.1%
20/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Investigations
Alanine aminotransferase increased
|
32.8%
65/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
0.00%
0/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Investigations
Aspartate aminotransferase increased
|
28.3%
56/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
0.00%
0/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Investigations
Gamma-glutamyltransferase increased
|
5.6%
11/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
1.1%
1/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Investigations
Transaminases increased
|
6.1%
12/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
1.1%
1/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Investigations
Weight decreased
|
10.1%
20/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
1.1%
1/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Metabolism and nutrition disorders
Decreased appetite
|
13.1%
26/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
2.1%
2/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Metabolism and nutrition disorders
Dehydration
|
5.6%
11/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
0.00%
0/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
10.6%
21/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
4.2%
4/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.5%
9/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
6.3%
6/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.5%
9/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
6.3%
6/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.1%
16/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
3.2%
3/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Nervous system disorders
Dizziness
|
6.1%
12/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
6.3%
6/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Nervous system disorders
Headache
|
15.2%
30/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
12.6%
12/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Psychiatric disorders
Anxiety
|
5.1%
10/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
3.2%
3/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Psychiatric disorders
Insomnia
|
10.6%
21/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
11.6%
11/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.1%
28/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
14.7%
14/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
6.1%
12/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
2.1%
2/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.1%
12/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
3.2%
3/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
12.6%
25/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
4.2%
4/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Skin and subcutaneous tissue disorders
Rash
|
19.2%
38/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
12.6%
12/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
8.1%
16/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
2.1%
2/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
|
Vascular disorders
Hypertension
|
6.1%
12/198 • Up to 27 months plus 30 days
Safety Analysis Set
|
2.1%
2/95 • Up to 27 months plus 30 days
Safety Analysis Set
|
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