Trial Outcomes & Findings for Efficacy and Safety Study of Idelalisib in Participants With Indolent B-Cell Non-Hodgkin Lymphomas (NCT NCT01282424)
NCT ID: NCT01282424
Last Updated: 2019-07-11
Results Overview
Overall response rate (ORR) was assessed based on the International Working Group Revised Response Criteria for Malignant Lymphoma (Cheson, 2007), and was defined as the percentage of participants achieving a complete response (CR) or partial response (PR; or minor response \[MR\] for participants with WM) as assessed by the study independent review committee (IRC). CR was defined as the complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease. PR was defined as a ≥ 50% reduction in the sum of the products of the longest perpendicular diameters of all index lesions, with no new lesions. For WM only, response was defined as a reduction in immunoglobulin M (IgM) of ≥ 50% decrease for PR, and ≥ 25% decrease for MR; no increase from baseline in the sum of the products of the longest perpendicular diameters of all index lesions, with no new lesions or signs and symptoms of active disease (Owen, 2013)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
125 participants
Primary outcome timeframe
Start of Treatment to End of Treatment (up to 81 months)
Results posted on
2019-07-11
Participant Flow
Participants were enrolled at a total of 54 study sites in North America and Europe. The first participant was screened on 04 March 2011. The last participant observation was on 16 May 2018.
125 participants were enrolled and treated and comprise the Intent-to-Treat (ITT) Analysis Set.
Participant milestones
| Measure |
Idelalisib
Idelalisib 150 mg tablet administered orally twice daily until tumor progression or development of unacceptable toxicity.
|
|---|---|
|
Treatment Period (TP) (81 Months)
STARTED
|
125
|
|
Treatment Period (TP) (81 Months)
Completed: Disease Progression
|
70
|
|
Treatment Period (TP) (81 Months)
Completed: Death
|
9
|
|
Treatment Period (TP) (81 Months)
COMPLETED
|
79
|
|
Treatment Period (TP) (81 Months)
NOT COMPLETED
|
46
|
|
Long-term Follow-up Period (5 Years)
STARTED
|
84
|
|
Long-term Follow-up Period (5 Years)
COMPLETED
|
20
|
|
Long-term Follow-up Period (5 Years)
NOT COMPLETED
|
64
|
Reasons for withdrawal
| Measure |
Idelalisib
Idelalisib 150 mg tablet administered orally twice daily until tumor progression or development of unacceptable toxicity.
|
|---|---|
|
Treatment Period (TP) (81 Months)
Adverse Event
|
30
|
|
Treatment Period (TP) (81 Months)
Withdrew Consent
|
6
|
|
Treatment Period (TP) (81 Months)
Investigator Request
|
7
|
|
Treatment Period (TP) (81 Months)
Other (Unknown)
|
3
|
|
Long-term Follow-up Period (5 Years)
Withdrew Consent
|
2
|
|
Long-term Follow-up Period (5 Years)
Death
|
40
|
|
Long-term Follow-up Period (5 Years)
Lost to Follow-up
|
1
|
|
Long-term Follow-up Period (5 Years)
Other (Unknown)
|
21
|
Baseline Characteristics
Efficacy and Safety Study of Idelalisib in Participants With Indolent B-Cell Non-Hodgkin Lymphomas
Baseline characteristics by cohort
| Measure |
Idelalisib
n=125 Participants
Idelalisib 150 mg tablet administered orally twice daily until tumor progression or development of unacceptable toxicity.
|
|---|---|
|
Age, Continuous
|
62 years
STANDARD_DEVIATION 11.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
45 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
80 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · White/Caucasian
|
110 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Missing
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Hispanic or Latino
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Not Hispanic or Latino
|
117 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Missing
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
France
|
10 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
83 Participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
10 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
6 Participants
n=5 Participants
|
|
Karnofsky Performance Status
Score = 60
|
2 Participants
n=5 Participants
|
|
Karnofsky Performance Status
Score = 70
|
6 Participants
n=5 Participants
|
|
Karnofsky Performance Status
Score = 80
|
27 Participants
n=5 Participants
|
|
Karnofsky Performance Status
Score = 90
|
44 Participants
n=5 Participants
|
|
Karnofsky Performance Status
Score = 100
|
46 Participants
n=5 Participants
|
|
Baseline Disease History
Folicular lymphoma
|
72 Participants
n=5 Participants
|
|
Baseline Disease History
Small lymphocytic lymphoma
|
28 Participants
n=5 Participants
|
|
Baseline Disease History
LPL/WM
|
10 Participants
n=5 Participants
|
|
Baseline Disease History
Marginal zone lymphoma
|
15 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Start of Treatment to End of Treatment (up to 81 months)Population: ITT Analysis Set included enrolled participants who received at least one dose of study drug.
Overall response rate (ORR) was assessed based on the International Working Group Revised Response Criteria for Malignant Lymphoma (Cheson, 2007), and was defined as the percentage of participants achieving a complete response (CR) or partial response (PR; or minor response \[MR\] for participants with WM) as assessed by the study independent review committee (IRC). CR was defined as the complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease. PR was defined as a ≥ 50% reduction in the sum of the products of the longest perpendicular diameters of all index lesions, with no new lesions. For WM only, response was defined as a reduction in immunoglobulin M (IgM) of ≥ 50% decrease for PR, and ≥ 25% decrease for MR; no increase from baseline in the sum of the products of the longest perpendicular diameters of all index lesions, with no new lesions or signs and symptoms of active disease (Owen, 2013)
Outcome measures
| Measure |
Idelalisib
n=125 Participants
Idelalisib 150 mg tablet administered orally twice daily until tumor progression or development of unacceptable toxicity.
|
|---|---|
|
Overall Response Rate
|
57.6 percentage of participants
Interval 48.4 to 66.4
|
SECONDARY outcome
Timeframe: Start of Treatment to End of Treatment (up to 81 months)Population: Participants in the ITT Analysis Set who achieved a CR or PR (or MR for participants with WM) were analyzed.
Duration of Response (DOR) was defined as the interval from the first documentation of CR or PR (or MR for participants with WM) to the earlier of the first documentation of disease progression as assessed by the study IRC or death from any cause. DOR was analyzed using Kaplan-Meier (KM) estimates.
Outcome measures
| Measure |
Idelalisib
n=72 Participants
Idelalisib 150 mg tablet administered orally twice daily until tumor progression or development of unacceptable toxicity.
|
|---|---|
|
Duration of Response
|
12.5 months
Interval 6.2 to 28.6
|
SECONDARY outcome
Timeframe: Start of Treatment to End of Treatment (up to 81 months)Population: Participants in the ITT Analysis Set were analyzed.
Lymph node response (LNR) was defined as the percentage of participants who achieved a ≥ 50% decrease from baseline in the sum of the product of the perpendicular diameters (SPD) of measurable index lesions as assessed by the study IRC.
Outcome measures
| Measure |
Idelalisib
n=125 Participants
Idelalisib 150 mg tablet administered orally twice daily until tumor progression or development of unacceptable toxicity.
|
|---|---|
|
Lymph Node Response Rate
|
56.8 percentage of participants
Interval 47.6 to 65.6
|
SECONDARY outcome
Timeframe: Start of Treatment to End of Treatment (up to 81 months)Population: Participants in the ITT Analysis Set who achieved a CR or PR (or MR for participants with WM) were analyzed.
Time to response (TTR) was defined as the interval from the start of idelalisib treatment to the first documentation of CR or PR (or MR for participants with WM) as assessed by the study IRC.
Outcome measures
| Measure |
Idelalisib
n=72 Participants
Idelalisib 150 mg tablet administered orally twice daily until tumor progression or development of unacceptable toxicity.
|
|---|---|
|
Time to Response
|
2.0 months
Interval 1.8 to 4.2
|
SECONDARY outcome
Timeframe: Start of Treatment to End of Treatment (up to 81 months)Population: Participants in the ITT Analysis Set were analyzed.
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 as assessed by the study IRC or death from any cause. PFS was analyzed using KM estimates.
Outcome measures
| Measure |
Idelalisib
n=125 Participants
Idelalisib 150 mg tablet administered orally twice daily until tumor progression or development of unacceptable toxicity.
|
|---|---|
|
Progression-Free Survival
|
11.1 months
Interval 8.3 to 14.0
|
SECONDARY outcome
Timeframe: Start of Treatment to Last Long-Term Follow-Up Visit (up to maximum of 7 years)Population: Participants in the ITT Analysis Set were analyzed.
Overall survival (OS) was defined as the time interval from the start of idelalisib treatment to death from any cause. OS was analyzed using KM estimates.
Outcome measures
| Measure |
Idelalisib
n=125 Participants
Idelalisib 150 mg tablet administered orally twice daily until tumor progression or development of unacceptable toxicity.
|
|---|---|
|
Overall Survival
|
48.6 months
Interval 33.9 to 71.7
|
SECONDARY outcome
Timeframe: Baseline to End of Treatment (up to 81 months)Population: Participants in the ITT Analysis Set with available data were analyzed.
Change in health-related quality of life events were reported by participants using the Functional Assessment of Cancer Therapy: Lymphoma Subscale (FACT-LymS) assessment tool. Results are presented as the mean (SD) best change from baseline. The best change from baseline was defined as the highest change score (improvement) after baseline. The FACT-LymS is on a scale from 0-60, with higher scores associated with a better quality of life. It incorporates values from 15 questions, each rated 0-4, related to study indications.
Outcome measures
| Measure |
Idelalisib
n=113 Participants
Idelalisib 150 mg tablet administered orally twice daily until tumor progression or development of unacceptable toxicity.
|
|---|---|
|
Change in Health-Related Quality of Life Using the Functional Assessment of Cancer Therapy: Lymphoma Subscale (FACT-LymS)
|
10.3 units on a scale
Standard Deviation 17.08
|
SECONDARY outcome
Timeframe: Baseline to End of Treatment (up to 81 months)Population: Participants in the ITT Analysis Set with available data were analyzed.
The change in Karnofsky performance status was reported as the best (highest change score) and worst (lowest change score) change from baseline using the Karnofsky performance criteria. The Karnofsky score classified participants according to their functional impairment. Scores are on a scale from 0-100, the lower the score, the worse the survival for most serious illnesses.
Outcome measures
| Measure |
Idelalisib
n=122 Participants
Idelalisib 150 mg tablet administered orally twice daily until tumor progression or development of unacceptable toxicity.
|
|---|---|
|
Change in Karnofsky Performance Status
Best change
|
3.0 units on a scale
Standard Deviation 8.71
|
|
Change in Karnofsky Performance Status
Worst change
|
-10.7 units on a scale
Standard Deviation 12.61
|
SECONDARY outcome
Timeframe: Enrollment to End of Treatment (up to 81 months)Analysis of the cytokine/chemokine was planned to be performed on a subset of samples from this study along with a subset of samples from other studies. Therefore, data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Start of Treatment to End of Treatment (up to 81 months) plus 30 daysPopulation: Participants in the ITT Analysis Set were analyzed.
This composite endpoint measured the safety and tolerability profile of idelalisib. "Clinically meaningful" abnormalities in vital signs and electrocardiograms (ECG) were as determined by the investigator.
Outcome measures
| Measure |
Idelalisib
n=125 Participants
Idelalisib 150 mg tablet administered orally twice daily until tumor progression or development of unacceptable toxicity.
|
|---|---|
|
Safety and Tolerability of Idelalisib Assessed as the Number of Participants Experiencing Adverse Events (AEs) or Abnormalities in Vital Signs, Laboratory Tests, or Electrocardiograms
Grade 3 or 4 hemoglobin
|
2 Participants
|
|
Safety and Tolerability of Idelalisib Assessed as the Number of Participants Experiencing Adverse Events (AEs) or Abnormalities in Vital Signs, Laboratory Tests, or Electrocardiograms
Grade 3 or 4 neutrophils
|
35 Participants
|
|
Safety and Tolerability of Idelalisib Assessed as the Number of Participants Experiencing Adverse Events (AEs) or Abnormalities in Vital Signs, Laboratory Tests, or Electrocardiograms
Grade 3 or 4 aspartate aminotransferase
|
11 Participants
|
|
Safety and Tolerability of Idelalisib Assessed as the Number of Participants Experiencing Adverse Events (AEs) or Abnormalities in Vital Signs, Laboratory Tests, or Electrocardiograms
Grade 3 or 4 platelets
|
9 Participants
|
|
Safety and Tolerability of Idelalisib Assessed as the Number of Participants Experiencing Adverse Events (AEs) or Abnormalities in Vital Signs, Laboratory Tests, or Electrocardiograms
Grade 3 or 4 alanine aminotransferase
|
16 Participants
|
|
Safety and Tolerability of Idelalisib Assessed as the Number of Participants Experiencing Adverse Events (AEs) or Abnormalities in Vital Signs, Laboratory Tests, or Electrocardiograms
Any AE
|
123 Participants
|
|
Safety and Tolerability of Idelalisib Assessed as the Number of Participants Experiencing Adverse Events (AEs) or Abnormalities in Vital Signs, Laboratory Tests, or Electrocardiograms
AE leading to drug discontinuation
|
35 Participants
|
|
Safety and Tolerability of Idelalisib Assessed as the Number of Participants Experiencing Adverse Events (AEs) or Abnormalities in Vital Signs, Laboratory Tests, or Electrocardiograms
Serious AE
|
72 Participants
|
|
Safety and Tolerability of Idelalisib Assessed as the Number of Participants Experiencing Adverse Events (AEs) or Abnormalities in Vital Signs, Laboratory Tests, or Electrocardiograms
Vital signs abnormal - clinically meaningful
|
0 Participants
|
|
Safety and Tolerability of Idelalisib Assessed as the Number of Participants Experiencing Adverse Events (AEs) or Abnormalities in Vital Signs, Laboratory Tests, or Electrocardiograms
ECG abnormal - clinically meaningful
|
0 Participants
|
SECONDARY outcome
Timeframe: Start of Treatment to End of Treatment (up to 81 months)Population: Participants in the ITT Analysis Set were analyzed.
The average idelalisib exposure was summarized.
Outcome measures
| Measure |
Idelalisib
n=125 Participants
Idelalisib 150 mg tablet administered orally twice daily until tumor progression or development of unacceptable toxicity.
|
|---|---|
|
Study Drug Exposure
|
13.2 months
Standard Deviation 15.08
|
SECONDARY outcome
Timeframe: Predose and at 1.5 hours (± 5 minutes) postdose on Day 29Population: Pharmacokinetic (PK) Analysis Set included participants in the ITT Analysis Set who had the necessary baseline and on-study measurements.
Outcome measures
| Measure |
Idelalisib
n=125 Participants
Idelalisib 150 mg tablet administered orally twice daily until tumor progression or development of unacceptable toxicity.
|
|---|---|
|
Idelalisib Plasma Concentration
Predose
|
471.6 ng/mL
Standard Deviation 486.53
|
|
Idelalisib Plasma Concentration
Postdose
|
2187.7 ng/mL
Standard Deviation 1050.76
|
SECONDARY outcome
Timeframe: Predose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose on Days 1 and 29Population: Participants in the PK Analysis Set with available data were analyzed.
Cmax at Days 1 and 29 was analyzed. Cmax is defined as the maximum concentration of drug.
Outcome measures
| Measure |
Idelalisib
n=8 Participants
Idelalisib 150 mg tablet administered orally twice daily until tumor progression or development of unacceptable toxicity.
|
|---|---|
|
PK Parameter: Cmax
Cmax at Day 1
|
2647.5 ng/mL
Standard Deviation 1084.99
|
|
PK Parameter: Cmax
Cmax at Day 29
|
2258.8 ng/mL
Standard Deviation 809.61
|
SECONDARY outcome
Timeframe: Predose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose on Days 1 and 29Population: Participants in the PK Analysis Set with available data were analyzed.
Tmax at Days 1 and 29 was analyzed. Tmax is defined as the time of Cmax (the maximum concentration of drug).
Outcome measures
| Measure |
Idelalisib
n=8 Participants
Idelalisib 150 mg tablet administered orally twice daily until tumor progression or development of unacceptable toxicity.
|
|---|---|
|
PK Parameter: Tmax
Tmax at Day 1
|
1.00 hours
Interval 0.99 to 1.04
|
|
PK Parameter: Tmax
Tmax at Day 29
|
1.00 hours
Interval 0.95 to 2.0
|
SECONDARY outcome
Timeframe: Predose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose on Days 1 and 29Population: Participants in the PK Analysis Set with available data were analyzed.
AUClast at Days 1 and 29 was analyzed. AUClast is defined as the concentration of drug from time zero to the last observable concentration
Outcome measures
| Measure |
Idelalisib
n=8 Participants
Idelalisib 150 mg tablet administered orally twice daily until tumor progression or development of unacceptable toxicity.
|
|---|---|
|
PK Parameter: AUClast
AUClast at Day 1
|
9094.76 hours x ng/mL
Standard Deviation 2960.391
|
|
PK Parameter: AUClast
AUClast at Day 29
|
9293.39 hours x ng/mL
Standard Deviation 3996.826
|
Adverse Events
Idelalisib
Serious events: 72 serious events
Other events: 123 other events
Deaths: 64 deaths
Serious adverse events
| Measure |
Idelalisib
n=125 participants at risk
Idelalisib 150 mg tablet administered orally twice daily until tumor progression or development of unacceptable toxicity.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.6%
2/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Autoimmune haemolytic anaemia
|
0.80%
1/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
4.0%
5/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Neutropenia
|
2.4%
3/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Splenic infarction
|
0.80%
1/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.80%
1/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.80%
1/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Cardiac disorders
Atrial fibrillation
|
0.80%
1/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Cardiac disorders
Cardiac arrest
|
0.80%
1/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Cardiac disorders
Cardiac failure
|
1.6%
2/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Cardiac disorders
Cardiomyopathy
|
0.80%
1/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Cardiac disorders
Sinus tachycardia
|
0.80%
1/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.80%
1/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Eye disorders
Visual impairment
|
0.80%
1/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.80%
1/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Acute abdomen
|
0.80%
1/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Autoimmune colitis
|
0.80%
1/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Colitis
|
4.0%
5/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
8.8%
11/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Enteritis
|
0.80%
1/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.80%
1/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.80%
1/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.80%
1/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Melaena
|
1.6%
2/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
0.80%
1/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
0.80%
1/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.80%
1/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.80%
1/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.80%
1/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Stomatitis
|
0.80%
1/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.80%
1/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
1.6%
2/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
General disorders
Asthenia
|
1.6%
2/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
General disorders
Chest pain
|
1.6%
2/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
General disorders
Death
|
0.80%
1/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
General disorders
Multiple organ dysfunction syndrome
|
1.6%
2/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
General disorders
Peripheral swelling
|
2.4%
3/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
General disorders
Pyrexia
|
12.0%
15/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.80%
1/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.80%
1/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Immune system disorders
Anaphylactic reaction
|
0.80%
1/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Immune system disorders
Autoimmune disorder
|
0.80%
1/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Infections and infestations
Cellulitis
|
0.80%
1/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Infections and infestations
Cytomegalovirus colitis
|
1.6%
2/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Infections and infestations
Device related infection
|
1.6%
2/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Infections and infestations
Gastroenteritis
|
0.80%
1/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Infections and infestations
Herpes zoster
|
0.80%
1/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Infections and infestations
Infective exacerbation of chronic obstructive airways disease
|
0.80%
1/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Infections and infestations
Lung infection
|
0.80%
1/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Infections and infestations
Perirectal abscess
|
1.6%
2/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Infections and infestations
Pharyngitis
|
0.80%
1/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
1.6%
2/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Infections and infestations
Pneumonia
|
12.0%
15/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Infections and infestations
Pneumonia cytomegaloviral
|
0.80%
1/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Infections and infestations
Pneumonia necrotising
|
0.80%
1/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Infections and infestations
Pneumonia pneumococcal
|
0.80%
1/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Infections and infestations
Pneumonia pseudomonal
|
0.80%
1/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Infections and infestations
Pneumonia staphylococcal
|
0.80%
1/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Infections and infestations
Pneumonia streptococcal
|
0.80%
1/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Infections and infestations
Sepsis
|
1.6%
2/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Infections and infestations
Sepsis syndrome
|
0.80%
1/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Infections and infestations
Septic shock
|
1.6%
2/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Infections and infestations
Sinusitis
|
0.80%
1/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Infections and infestations
Soft tissue infection
|
0.80%
1/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Infections and infestations
Staphylococcal infection
|
0.80%
1/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Infections and infestations
Toxoplasmosis
|
0.80%
1/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
1.6%
2/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Infections and infestations
Varicella zoster virus infection
|
0.80%
1/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Infections and infestations
Wound infection
|
0.80%
1/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
0.80%
1/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.80%
1/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.80%
1/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.80%
1/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.80%
1/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.80%
1/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
3.2%
4/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.80%
1/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
1.6%
2/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
1.6%
2/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.80%
1/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.80%
1/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.80%
1/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
0.80%
1/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.80%
1/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.80%
1/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin cancer
|
0.80%
1/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
1.6%
2/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.80%
1/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.80%
1/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Nervous system disorders
Paraplegia
|
0.80%
1/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Anxiety
|
0.80%
1/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Acute kidney injury
|
3.2%
4/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.80%
1/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
1.6%
2/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.4%
3/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.80%
1/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.80%
1/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.6%
2/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
1.6%
2/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.4%
3/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.80%
1/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis exfoliative generalised
|
0.80%
1/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.80%
1/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.80%
1/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Vascular disorders
Deep vein thrombosis
|
0.80%
1/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Vascular disorders
Hypotension
|
1.6%
2/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Vascular disorders
Lymphorrhoea
|
0.80%
1/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
Other adverse events
| Measure |
Idelalisib
n=125 participants at risk
Idelalisib 150 mg tablet administered orally twice daily until tumor progression or development of unacceptable toxicity.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
14.4%
18/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Leukopenia
|
7.2%
9/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Neutropenia
|
28.0%
35/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
18.4%
23/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
16.8%
21/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
8.0%
10/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
8.8%
11/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
47.2%
59/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Dysphagia
|
5.6%
7/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
30.4%
38/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Stomatitis
|
6.4%
8/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
16.0%
20/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
General disorders
Asthenia
|
11.2%
14/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
General disorders
Chills
|
8.8%
11/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
General disorders
Fatigue
|
32.0%
40/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
General disorders
Mucosal inflammation
|
6.4%
8/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
General disorders
Oedema peripheral
|
10.4%
13/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
General disorders
Pain
|
7.2%
9/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
General disorders
Pyrexia
|
27.2%
34/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Infections and infestations
Bronchitis
|
5.6%
7/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Infections and infestations
Herpes zoster
|
5.6%
7/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Infections and infestations
Pneumonia
|
6.4%
8/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
18.4%
23/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
6.4%
8/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Investigations
Alanine aminotransferase increased
|
14.4%
18/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
12.8%
16/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Investigations
Blood creatinine increased
|
7.2%
9/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Investigations
Blood lactate dehydrogenase increased
|
5.6%
7/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Investigations
Weight decreased
|
15.2%
19/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
18.4%
23/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
8.0%
10/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
8.8%
11/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
5.6%
7/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
12.0%
15/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.4%
8/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.4%
13/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Nervous system disorders
Dizziness
|
8.8%
11/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Nervous system disorders
Dysgeusia
|
5.6%
7/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
13.6%
17/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
9.6%
12/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
32.0%
40/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
17.6%
22/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
8.8%
11/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
5.6%
7/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
7.2%
9/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
14.4%
18/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.2%
9/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
14.4%
18/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Vascular disorders
Hypertension
|
7.2%
9/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
|
Vascular disorders
Hypotension
|
6.4%
8/125 • Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
|
Additional Information
Gilead Clinical Study Information Center
Gilead Sciences
Phone: 1-833-445-3230 (GILEAD-0)
Email: [email protected]
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