Trial Outcomes & Findings for Idelalisib in Combination With Rituximab for Previously Untreated Follicular Lymphoma and Small Lymphocytic Lymphoma (NCT NCT02258529)
NCT ID: NCT02258529
Last Updated: 2019-05-14
Results Overview
Overall response rate (ORR) was defined as the proportion of participants who achieve a confirmed complete or partial response during idelalisib treatment. ORR was to be assessed by an independent review committee (IRC).
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
10 participants
Results posted on
2019-05-14
Participant Flow
Participants were enrolled at study sites in the United States. The first participant was screened on 14 September 2015. The last study visit occurred on 03 May 2016.
20 participants were screened.
Participant milestones
| Measure |
Idelalisib + Rituximab
Idelalisib (Zydelig®) 150 mg tablet twice daily for up to 104 weeks + rituximab 375 mg/m\^2 intravenously (once weekly for 4 weeks and then every 8 weeks from Week 12 up to Week 100)
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
10
|
Reasons for withdrawal
| Measure |
Idelalisib + Rituximab
Idelalisib (Zydelig®) 150 mg tablet twice daily for up to 104 weeks + rituximab 375 mg/m\^2 intravenously (once weekly for 4 weeks and then every 8 weeks from Week 12 up to Week 100)
|
|---|---|
|
Overall Study
Study Terminated by Sponsor
|
9
|
|
Overall Study
Adverse Event
|
1
|
Baseline Characteristics
Idelalisib in Combination With Rituximab for Previously Untreated Follicular Lymphoma and Small Lymphocytic Lymphoma
Baseline characteristics by cohort
| Measure |
Idelalisib + Rituximab
n=10 Participants
Idelalisib 150 mg tablet twice daily for up to 104 weeks + rituximab 375 mg/m\^2 intravenously (once weekly for 4 weeks and then every 8 weeks from Week 12 up to Week 100)
|
|---|---|
|
Age, Continuous
|
69 years
STANDARD_DEVIATION 11.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 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.
Overall response rate (ORR) was defined as the proportion of participants who achieve a confirmed complete or partial response during idelalisib treatment. ORR was to be assessed by an independent review committee (IRC).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 24 weeks plus 30 daysPopulation: Intent-to-Treat (ITT) Analysis Set: all participants who received at least 1 dose of study drug.
Outcome measures
| Measure |
Idelalisib + Rituximab
n=10 Participants
Idelalisib 150 mg tablet twice daily for up to 104 weeks + rituximab 375 mg/m\^2 intravenously (once weekly for 4 weeks and then every 8 weeks from Week 12 up to Week 100)
|
|---|---|
|
Overall Safety Profile of Idelalisib as Measured by the Incidence of Adverse Events (AEs), Severe AEs (SAEs), AEs Leading to Idelalisib (IDL) Interruption, Idelalisib Dose Reduction, Premature Discontinuation of Idelalisib, or Death
Any AE
|
90.0 percentage of participants
|
|
Overall Safety Profile of Idelalisib as Measured by the Incidence of Adverse Events (AEs), Severe AEs (SAEs), AEs Leading to Idelalisib (IDL) Interruption, Idelalisib Dose Reduction, Premature Discontinuation of Idelalisib, or Death
Any SAEs
|
30.0 percentage of participants
|
|
Overall Safety Profile of Idelalisib as Measured by the Incidence of Adverse Events (AEs), Severe AEs (SAEs), AEs Leading to Idelalisib (IDL) Interruption, Idelalisib Dose Reduction, Premature Discontinuation of Idelalisib, or Death
Any AE Leading to Idelalisib Interruption
|
60.0 percentage of participants
|
|
Overall Safety Profile of Idelalisib as Measured by the Incidence of Adverse Events (AEs), Severe AEs (SAEs), AEs Leading to Idelalisib (IDL) Interruption, Idelalisib Dose Reduction, Premature Discontinuation of Idelalisib, or Death
Any AE Leading to Idelalisib Dose Reduction
|
30.0 percentage of participants
|
|
Overall Safety Profile of Idelalisib as Measured by the Incidence of Adverse Events (AEs), Severe AEs (SAEs), AEs Leading to Idelalisib (IDL) Interruption, Idelalisib Dose Reduction, Premature Discontinuation of Idelalisib, or Death
Any AE Leading to Premature Discontinuation of IDL
|
10.0 percentage of participants
|
|
Overall Safety Profile of Idelalisib as Measured by the Incidence of Adverse Events (AEs), Severe AEs (SAEs), AEs Leading to Idelalisib (IDL) Interruption, Idelalisib Dose Reduction, Premature Discontinuation of Idelalisib, or Death
Any AE Leading to Death
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 24 weeks plus 30 daysPopulation: ITT Analysis Set: all participants who received at least 1 dose of study drug.
The rate of Grade ≥ 3 transaminase elevations was defined as the number of participants with any Grade 3 or 4 alanine aminotransferase (ALT) or aspartate aminotransferase (AST) elevations.
Outcome measures
| Measure |
Idelalisib + Rituximab
n=10 Participants
Idelalisib 150 mg tablet twice daily for up to 104 weeks + rituximab 375 mg/m\^2 intravenously (once weekly for 4 weeks and then every 8 weeks from Week 12 up to Week 100)
|
|---|---|
|
Rate of Grade ≥ 3 Transaminase Elevations Based on Laboratory Findings
Any Grade 3 or 4 ALT Elevation
|
40.0 percentage of participants
|
|
Rate of Grade ≥ 3 Transaminase Elevations Based on Laboratory Findings
Any Grade 3 or 4 AST Elevation
|
10.0 percentage of participants
|
SECONDARY outcome
Timeframe: Predose and 1.5 hour postdose at Weeks 2, 4, and 12Population: Pharmacokinetic (PK) Analysis Set: all participants in the ITT Analysis Set who had the necessary baseline and on-study measurements to provide interpretable results for the specific parameters of interest.
Outcome measures
| Measure |
Idelalisib + Rituximab
n=9 Participants
Idelalisib 150 mg tablet twice daily for up to 104 weeks + rituximab 375 mg/m\^2 intravenously (once weekly for 4 weeks and then every 8 weeks from Week 12 up to Week 100)
|
|---|---|
|
Idelalisib Trough and Peak Plasma Concentrations
Week 12 1.5 hours postdose
|
1313.1 ng/mL
Standard Deviation 1474.87
|
|
Idelalisib Trough and Peak Plasma Concentrations
Week 2 predose
|
216.2 ng/mL
Standard Deviation 161.73
|
|
Idelalisib Trough and Peak Plasma Concentrations
Week 2 1.5 hours postdose
|
2240.0 ng/mL
Standard Deviation 880.03
|
|
Idelalisib Trough and Peak Plasma Concentrations
Week 4 predose
|
347.4 ng/mL
Standard Deviation 365.57
|
|
Idelalisib Trough and Peak Plasma Concentrations
Week 4 1.5 hours postdose
|
2084.3 ng/mL
Standard Deviation 1346.26
|
|
Idelalisib Trough and Peak Plasma Concentrations
Week 12 predose
|
290.5 ng/mL
Standard Deviation 373.08
|
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.
Time to response was defined as the the interval from the start of idelalisib treatment to the first documentation of complete or partial response.
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.
Duration of response (DOR) was defined as the interval from the first documentation of complete response or partial response to the earlier of the first documentation of disease progression or death from any cause.
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.
Progression-free survival (PFS) was defined as the interval from the start of idelalisib treatment to the earlier of the first documentation of disease progression or death from any cause.
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 was defined as the interval from enrollment to death from any cause.
Outcome measures
Outcome data not reported
SECONDARY outcome
Population: Due to the early termination of the study, data were not available for all participants, and therefore this prespecified analysis was not conducted.
Changes in health-related quality of life was to be reported by participants using the Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) questionnaire.
Outcome measures
Outcome data not reported
Adverse Events
Idelalisib + Rituximab
Serious events: 3 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Idelalisib + Rituximab
n=10 participants at risk
Idelalisib 150 mg tablet twice daily for up to 104 weeks + rituximab 375 mg/m\^2 intravenously (once weekly for 4 weeks and then every 8 weeks from Week 12 up to Week 100)
|
|---|---|
|
General disorders
Oedema peripheral
|
10.0%
1/10 • Baseline up to the last dose date plus 30 days (maximum: 24.1 weeks)
ITT Analysis Set: all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Sepsis
|
10.0%
1/10 • Baseline up to the last dose date plus 30 days (maximum: 24.1 weeks)
ITT Analysis Set: all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
10.0%
1/10 • Baseline up to the last dose date plus 30 days (maximum: 24.1 weeks)
ITT Analysis Set: all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Trigeminal neuralgia
|
10.0%
1/10 • Baseline up to the last dose date plus 30 days (maximum: 24.1 weeks)
ITT Analysis Set: all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
10.0%
1/10 • Baseline up to the last dose date plus 30 days (maximum: 24.1 weeks)
ITT Analysis Set: all participants who received at least 1 dose of study drug.
|
Other adverse events
| Measure |
Idelalisib + Rituximab
n=10 participants at risk
Idelalisib 150 mg tablet twice daily for up to 104 weeks + rituximab 375 mg/m\^2 intravenously (once weekly for 4 weeks and then every 8 weeks from Week 12 up to Week 100)
|
|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
30.0%
3/10 • Baseline up to the last dose date plus 30 days (maximum: 24.1 weeks)
ITT Analysis Set: all participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
10.0%
1/10 • Baseline up to the last dose date plus 30 days (maximum: 24.1 weeks)
ITT Analysis Set: all participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Palpitations
|
10.0%
1/10 • Baseline up to the last dose date plus 30 days (maximum: 24.1 weeks)
ITT Analysis Set: all participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Sinus tachycardia
|
10.0%
1/10 • Baseline up to the last dose date plus 30 days (maximum: 24.1 weeks)
ITT Analysis Set: all participants who received at least 1 dose of study drug.
|
|
Ear and labyrinth disorders
Ear pruritus
|
10.0%
1/10 • Baseline up to the last dose date plus 30 days (maximum: 24.1 weeks)
ITT Analysis Set: all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal distension
|
10.0%
1/10 • Baseline up to the last dose date plus 30 days (maximum: 24.1 weeks)
ITT Analysis Set: all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
10.0%
1/10 • Baseline up to the last dose date plus 30 days (maximum: 24.1 weeks)
ITT Analysis Set: all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
10.0%
1/10 • Baseline up to the last dose date plus 30 days (maximum: 24.1 weeks)
ITT Analysis Set: all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
30.0%
3/10 • Baseline up to the last dose date plus 30 days (maximum: 24.1 weeks)
ITT Analysis Set: all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
10.0%
1/10 • Baseline up to the last dose date plus 30 days (maximum: 24.1 weeks)
ITT Analysis Set: all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Duodenitis
|
10.0%
1/10 • Baseline up to the last dose date plus 30 days (maximum: 24.1 weeks)
ITT Analysis Set: all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastritis
|
10.0%
1/10 • Baseline up to the last dose date plus 30 days (maximum: 24.1 weeks)
ITT Analysis Set: all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Hiatus hernia
|
10.0%
1/10 • Baseline up to the last dose date plus 30 days (maximum: 24.1 weeks)
ITT Analysis Set: all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Lip dry
|
10.0%
1/10 • Baseline up to the last dose date plus 30 days (maximum: 24.1 weeks)
ITT Analysis Set: all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
20.0%
2/10 • Baseline up to the last dose date plus 30 days (maximum: 24.1 weeks)
ITT Analysis Set: all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Oesophagitis
|
10.0%
1/10 • Baseline up to the last dose date plus 30 days (maximum: 24.1 weeks)
ITT Analysis Set: all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Stomatitis
|
10.0%
1/10 • Baseline up to the last dose date plus 30 days (maximum: 24.1 weeks)
ITT Analysis Set: all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
30.0%
3/10 • Baseline up to the last dose date plus 30 days (maximum: 24.1 weeks)
ITT Analysis Set: all participants who received at least 1 dose of study drug.
|
|
General disorders
Asthenia
|
10.0%
1/10 • Baseline up to the last dose date plus 30 days (maximum: 24.1 weeks)
ITT Analysis Set: all participants who received at least 1 dose of study drug.
|
|
General disorders
Chills
|
20.0%
2/10 • Baseline up to the last dose date plus 30 days (maximum: 24.1 weeks)
ITT Analysis Set: all participants who received at least 1 dose of study drug.
|
|
General disorders
Fatigue
|
30.0%
3/10 • Baseline up to the last dose date plus 30 days (maximum: 24.1 weeks)
ITT Analysis Set: all participants who received at least 1 dose of study drug.
|
|
General disorders
Mucosal inflammation
|
10.0%
1/10 • Baseline up to the last dose date plus 30 days (maximum: 24.1 weeks)
ITT Analysis Set: all participants who received at least 1 dose of study drug.
|
|
General disorders
Oedema peripheral
|
20.0%
2/10 • Baseline up to the last dose date plus 30 days (maximum: 24.1 weeks)
ITT Analysis Set: all participants who received at least 1 dose of study drug.
|
|
General disorders
Peripheral swelling
|
10.0%
1/10 • Baseline up to the last dose date plus 30 days (maximum: 24.1 weeks)
ITT Analysis Set: all participants who received at least 1 dose of study drug.
|
|
General disorders
Pyrexia
|
20.0%
2/10 • Baseline up to the last dose date plus 30 days (maximum: 24.1 weeks)
ITT Analysis Set: all participants who received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
10.0%
1/10 • Baseline up to the last dose date plus 30 days (maximum: 24.1 weeks)
ITT Analysis Set: all participants who received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Hepatitis acute
|
10.0%
1/10 • Baseline up to the last dose date plus 30 days (maximum: 24.1 weeks)
ITT Analysis Set: all participants who received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Periportal oedema
|
10.0%
1/10 • Baseline up to the last dose date plus 30 days (maximum: 24.1 weeks)
ITT Analysis Set: all participants who received at least 1 dose of study drug.
|
|
Immune system disorders
Hypersensitivity
|
10.0%
1/10 • Baseline up to the last dose date plus 30 days (maximum: 24.1 weeks)
ITT Analysis Set: all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Bronchitis
|
10.0%
1/10 • Baseline up to the last dose date plus 30 days (maximum: 24.1 weeks)
ITT Analysis Set: all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Oral candidiasis
|
10.0%
1/10 • Baseline up to the last dose date plus 30 days (maximum: 24.1 weeks)
ITT Analysis Set: all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
10.0%
1/10 • Baseline up to the last dose date plus 30 days (maximum: 24.1 weeks)
ITT Analysis Set: all participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
10.0%
1/10 • Baseline up to the last dose date plus 30 days (maximum: 24.1 weeks)
ITT Analysis Set: all participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
40.0%
4/10 • Baseline up to the last dose date plus 30 days (maximum: 24.1 weeks)
ITT Analysis Set: all participants who received at least 1 dose of study drug.
|
|
Investigations
Alanine aminotransferase increased
|
50.0%
5/10 • Baseline up to the last dose date plus 30 days (maximum: 24.1 weeks)
ITT Analysis Set: all participants who received at least 1 dose of study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
50.0%
5/10 • Baseline up to the last dose date plus 30 days (maximum: 24.1 weeks)
ITT Analysis Set: all participants who received at least 1 dose of study drug.
|
|
Investigations
Blood cholesterol increased
|
10.0%
1/10 • Baseline up to the last dose date plus 30 days (maximum: 24.1 weeks)
ITT Analysis Set: all participants who received at least 1 dose of study drug.
|
|
Investigations
Liver function test increased
|
20.0%
2/10 • Baseline up to the last dose date plus 30 days (maximum: 24.1 weeks)
ITT Analysis Set: all participants who received at least 1 dose of study drug.
|
|
Investigations
Lymphocyte count decreased
|
10.0%
1/10 • Baseline up to the last dose date plus 30 days (maximum: 24.1 weeks)
ITT Analysis Set: all participants who received at least 1 dose of study drug.
|
|
Investigations
Neutrophil count decreased
|
10.0%
1/10 • Baseline up to the last dose date plus 30 days (maximum: 24.1 weeks)
ITT Analysis Set: all participants who received at least 1 dose of study drug.
|
|
Investigations
Platelet count decreased
|
10.0%
1/10 • Baseline up to the last dose date plus 30 days (maximum: 24.1 weeks)
ITT Analysis Set: all participants who received at least 1 dose of study drug.
|
|
Investigations
Weight decreased
|
10.0%
1/10 • Baseline up to the last dose date plus 30 days (maximum: 24.1 weeks)
ITT Analysis Set: all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
10.0%
1/10 • Baseline up to the last dose date plus 30 days (maximum: 24.1 weeks)
ITT Analysis Set: all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
10.0%
1/10 • Baseline up to the last dose date plus 30 days (maximum: 24.1 weeks)
ITT Analysis Set: all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
10.0%
1/10 • Baseline up to the last dose date plus 30 days (maximum: 24.1 weeks)
ITT Analysis Set: all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
10.0%
1/10 • Baseline up to the last dose date plus 30 days (maximum: 24.1 weeks)
ITT Analysis Set: all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
10.0%
1/10 • Baseline up to the last dose date plus 30 days (maximum: 24.1 weeks)
ITT Analysis Set: all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Malnutrition
|
10.0%
1/10 • Baseline up to the last dose date plus 30 days (maximum: 24.1 weeks)
ITT Analysis Set: all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.0%
1/10 • Baseline up to the last dose date plus 30 days (maximum: 24.1 weeks)
ITT Analysis Set: all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
10.0%
1/10 • Baseline up to the last dose date plus 30 days (maximum: 24.1 weeks)
ITT Analysis Set: all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
10.0%
1/10 • Baseline up to the last dose date plus 30 days (maximum: 24.1 weeks)
ITT Analysis Set: all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
20.0%
2/10 • Baseline up to the last dose date plus 30 days (maximum: 24.1 weeks)
ITT Analysis Set: all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Dementia
|
10.0%
1/10 • Baseline up to the last dose date plus 30 days (maximum: 24.1 weeks)
ITT Analysis Set: all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Dizziness
|
10.0%
1/10 • Baseline up to the last dose date plus 30 days (maximum: 24.1 weeks)
ITT Analysis Set: all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Dysarthria
|
10.0%
1/10 • Baseline up to the last dose date plus 30 days (maximum: 24.1 weeks)
ITT Analysis Set: all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
10.0%
1/10 • Baseline up to the last dose date plus 30 days (maximum: 24.1 weeks)
ITT Analysis Set: all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Hypoaesthesia
|
10.0%
1/10 • Baseline up to the last dose date plus 30 days (maximum: 24.1 weeks)
ITT Analysis Set: all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Neuropathy peripheral
|
10.0%
1/10 • Baseline up to the last dose date plus 30 days (maximum: 24.1 weeks)
ITT Analysis Set: all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Paraesthesia
|
10.0%
1/10 • Baseline up to the last dose date plus 30 days (maximum: 24.1 weeks)
ITT Analysis Set: all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Transient ischaemic attack
|
10.0%
1/10 • Baseline up to the last dose date plus 30 days (maximum: 24.1 weeks)
ITT Analysis Set: all participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Acute psychosis
|
10.0%
1/10 • Baseline up to the last dose date plus 30 days (maximum: 24.1 weeks)
ITT Analysis Set: all participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Delirium
|
10.0%
1/10 • Baseline up to the last dose date plus 30 days (maximum: 24.1 weeks)
ITT Analysis Set: all participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
10.0%
1/10 • Baseline up to the last dose date plus 30 days (maximum: 24.1 weeks)
ITT Analysis Set: all participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Acute kidney injury
|
30.0%
3/10 • Baseline up to the last dose date plus 30 days (maximum: 24.1 weeks)
ITT Analysis Set: all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.0%
1/10 • Baseline up to the last dose date plus 30 days (maximum: 24.1 weeks)
ITT Analysis Set: all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
10.0%
1/10 • Baseline up to the last dose date plus 30 days (maximum: 24.1 weeks)
ITT Analysis Set: all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
20.0%
2/10 • Baseline up to the last dose date plus 30 days (maximum: 24.1 weeks)
ITT Analysis Set: all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
10.0%
1/10 • Baseline up to the last dose date plus 30 days (maximum: 24.1 weeks)
ITT Analysis Set: all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
10.0%
1/10 • Baseline up to the last dose date plus 30 days (maximum: 24.1 weeks)
ITT Analysis Set: all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
10.0%
1/10 • Baseline up to the last dose date plus 30 days (maximum: 24.1 weeks)
ITT Analysis Set: all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
10.0%
1/10 • Baseline up to the last dose date plus 30 days (maximum: 24.1 weeks)
ITT Analysis Set: all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
10.0%
1/10 • Baseline up to the last dose date plus 30 days (maximum: 24.1 weeks)
ITT Analysis Set: all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
10.0%
1/10 • Baseline up to the last dose date plus 30 days (maximum: 24.1 weeks)
ITT Analysis Set: all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
10.0%
1/10 • Baseline up to the last dose date plus 30 days (maximum: 24.1 weeks)
ITT Analysis Set: all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
10.0%
1/10 • Baseline up to the last dose date plus 30 days (maximum: 24.1 weeks)
ITT Analysis Set: all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
10.0%
1/10 • Baseline up to the last dose date plus 30 days (maximum: 24.1 weeks)
ITT Analysis Set: all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
30.0%
3/10 • Baseline up to the last dose date plus 30 days (maximum: 24.1 weeks)
ITT Analysis Set: all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
30.0%
3/10 • Baseline up to the last dose date plus 30 days (maximum: 24.1 weeks)
ITT Analysis Set: all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
10.0%
1/10 • Baseline up to the last dose date plus 30 days (maximum: 24.1 weeks)
ITT Analysis Set: all participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Flushing
|
20.0%
2/10 • Baseline up to the last dose date plus 30 days (maximum: 24.1 weeks)
ITT Analysis Set: all participants who received at least 1 dose of study drug.
|
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