Trial Outcomes & Findings for Dose Optimization Study of Idelalisib in Follicular Lymphoma (NCT NCT02536300)
NCT ID: NCT02536300
Last Updated: 2023-08-14
Results Overview
ORR was defined as percentage of participants who achieve a partial response (PR) or complete response (CR). PR criteria: No evidence of new disease, a ≥50% decrease from baseline in sum of products of diameters (SPD) of index lesions, no increase in non-index disease, no increase in liver/spleen size and no new liver/spleen enlargement. Persistence of bone marrow involvement in a participant who meets other criteria for CR based on the disappearance of all nodal and extra-nodal masses. CR criteria: No evidence of new disease, regression of all index nodal lesions to normal size (≤1.5 cm in longest dimension (LD) for large nodes and ≤1.0 cm in LD, ≤1.0 cm in longest perpendicular dimension (LPD) for small nodes), regression to normal of all nodal non-index disease, disappearance of all detectable extra-nodal index and non-index disease, normal spleen and liver size, no new liver/spleen enlargement, morphologically negative bone marrow.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
96 participants
Primary outcome timeframe
Randomization up to end of treatment (maximum duration: 73.5 months)
Results posted on
2023-08-14
Participant Flow
Participants were enrolled at study sites in Australia, Canada, Europe, Israel, and the United Kingdom.
145 participants were screened.
Participant milestones
| Measure |
Idelalisib 150 mg BID
Participants received idelalisib 150 mg tablets, orally, twice daily (BID), continuously for up to maximum 33.5 months.
|
Idelalisib 100 mg BID
Participants received idelalisib 100 mg tablets, orally, BID, continuously for up to maximum 63.6 months.
|
Idelalisib 150 mg BID INT
Participants received idelalisib 150 mg tablets, orally, BID for 21 days and 7 days off-treatment (intermittent \[INT\] dosing schedule) in each 28-day cycle for up to maximum of 24.6 months.
|
|---|---|---|---|
|
Overall Study
STARTED
|
47
|
27
|
22
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
47
|
27
|
22
|
Reasons for withdrawal
| Measure |
Idelalisib 150 mg BID
Participants received idelalisib 150 mg tablets, orally, twice daily (BID), continuously for up to maximum 33.5 months.
|
Idelalisib 100 mg BID
Participants received idelalisib 100 mg tablets, orally, BID, continuously for up to maximum 63.6 months.
|
Idelalisib 150 mg BID INT
Participants received idelalisib 150 mg tablets, orally, BID for 21 days and 7 days off-treatment (intermittent \[INT\] dosing schedule) in each 28-day cycle for up to maximum of 24.6 months.
|
|---|---|---|---|
|
Overall Study
Investigator's Discretion
|
17
|
11
|
2
|
|
Overall Study
Progressive Disease
|
11
|
7
|
6
|
|
Overall Study
Study Terminated by Sponsor
|
6
|
4
|
7
|
|
Overall Study
Death
|
7
|
0
|
5
|
|
Overall Study
Withdrew Consent
|
4
|
2
|
0
|
|
Overall Study
Initiation of Non-study Specific Anti-cancer Therapy in the Absence of Progression
|
1
|
2
|
1
|
|
Overall Study
Enrolled but Never Treated
|
0
|
0
|
1
|
|
Overall Study
Non-compliance With Study Drug
|
1
|
0
|
0
|
|
Overall Study
Protocol Violation
|
0
|
1
|
0
|
Baseline Characteristics
Dose Optimization Study of Idelalisib in Follicular Lymphoma
Baseline characteristics by cohort
| Measure |
Idelalisib 150 mg BID
n=47 Participants
Participants received idelalisib 150 mg tablets, orally, BID, continuously for up to maximum 33.5 months.
|
Idelalisib 100 mg BID
n=27 Participants
Participants received idelalisib 100 mg tablets, orally, BID, continuously for up to maximum 63.6 months.
|
Idelalisib 150 mg BID INT
n=21 Participants
Participants received idelalisib 150 mg tablets, orally, BID for 21 days and 7 days off-treatment (INT dosing schedule) in each 28-day cycle for up to maximum of 24.6 months.
|
Total
n=95 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
45 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
27 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
50 Participants
n=4 Participants
|
|
Age, Continuous
|
65 years
STANDARD_DEVIATION 13.0 • n=5 Participants
|
62 years
STANDARD_DEVIATION 13.6 • n=7 Participants
|
63 years
STANDARD_DEVIATION 11.6 • n=5 Participants
|
64 years
STANDARD_DEVIATION 12.8 • n=4 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
51 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
42 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
85 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
42 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
85 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · Unknown or Not Reported
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · Other or More Than One Race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Region of Enrollment
Italy
|
10 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Region of Enrollment
Poland
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Region of Enrollment
Spain
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Region of Enrollment
United Kingdom
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Region of Enrollment
France
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Region of Enrollment
Czechia
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Region of Enrollment
Israel
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Region of Enrollment
Australia
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Region of Enrollment
Canada
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Region of Enrollment
Romania
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Randomization up to end of treatment (maximum duration: 73.5 months)Population: Intent-to-Treat (ITT) analysis set included all participants who were randomized regardless of whether they received any study drug.
ORR was defined as percentage of participants who achieve a partial response (PR) or complete response (CR). PR criteria: No evidence of new disease, a ≥50% decrease from baseline in sum of products of diameters (SPD) of index lesions, no increase in non-index disease, no increase in liver/spleen size and no new liver/spleen enlargement. Persistence of bone marrow involvement in a participant who meets other criteria for CR based on the disappearance of all nodal and extra-nodal masses. CR criteria: No evidence of new disease, regression of all index nodal lesions to normal size (≤1.5 cm in longest dimension (LD) for large nodes and ≤1.0 cm in LD, ≤1.0 cm in longest perpendicular dimension (LPD) for small nodes), regression to normal of all nodal non-index disease, disappearance of all detectable extra-nodal index and non-index disease, normal spleen and liver size, no new liver/spleen enlargement, morphologically negative bone marrow.
Outcome measures
| Measure |
Idelalisib 150 mg BID
n=47 Participants
Participants received idelalisib 150 mg tablets, orally, BID, continuously for up to maximum 33.5 months.
|
Idelalisib 100 mg BID
n=27 Participants
Participants received idelalisib 100 mg tablets, orally, BID, continuously for up to maximum 63.6 months.
|
Idelalisib 150 mg BID INT
n=22 Participants
Participants received idelalisib 150 mg tablets, orally, BID for 21 days and 7 days off-treatment (INT dosing schedule) in each 28-day cycle for up to maximum of 24.6 months.
|
|---|---|---|---|
|
Overall Response Rate (ORR)
|
38.3 percentage of participants
Interval 24.5 to 53.6
|
44.4 percentage of participants
Interval 25.5 to 64.7
|
40.9 percentage of participants
Interval 20.7 to 63.6
|
PRIMARY outcome
Timeframe: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)Population: Safety analysis set included all participants who received at least 1 dose of study drug.
TEAEs were defined as 1 or both of any AEs leading to premature discontinuation of study drug, or any AEs with an onset date on or after the study drug start date and no later than the last exposure date after permanent discontinuation of the study drug. TEAEs severity was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0. Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening; Grade 5: Fatal. Participants were counted at the highest AE grade experienced.
Outcome measures
| Measure |
Idelalisib 150 mg BID
n=47 Participants
Participants received idelalisib 150 mg tablets, orally, BID, continuously for up to maximum 33.5 months.
|
Idelalisib 100 mg BID
n=27 Participants
Participants received idelalisib 100 mg tablets, orally, BID, continuously for up to maximum 63.6 months.
|
Idelalisib 150 mg BID INT
n=21 Participants
Participants received idelalisib 150 mg tablets, orally, BID for 21 days and 7 days off-treatment (INT dosing schedule) in each 28-day cycle for up to maximum of 24.6 months.
|
|---|---|---|---|
|
Number of Participants With Grade 4 or Higher Treatment-Emergent Adverse Events (TEAEs)
|
15 Participants
|
12 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: From first documentation of CR or PR until PD or death from any cause (maximum duration: 73.5 months)Population: Participants in the ITT analysis set who achieved CR or PR were analyzed.
DOR: interval from first documentation of CR/PR to earlier of first documentation of disease progression (PD) by independent review committee (IRC)/death from any cause. PR:No evidence of new disease,≥50% decrease from baseline in SPD of index lesions,no increase in non-index disease, no increase in liver/spleen size,no new liver/spleen enlargement; Persistence of bone marrow involvement in participant who meets other CR criteria. CR: No evidence of new disease,regression of all index nodal lesions to normal size (large nodes:≤1.5 cm in LD;small nodes:≤1.0 cm in LD,≤1.0 cm in LPD), regression to normal of all nodal non-index disease,disappearance of all detectable extra-nodal index,non-index disease,normal spleen and liver size, no new liver/spleen enlargement; PD: New node of \>1.5 cm or \>1.0 to ≤1.5 cm in LD, \>1.0 cm in LPD, new/unequivocal reappearance of resolved extra-nodal lesion,new non-index disease,increase by 50% in SPD of index lesions,LD of individual node/extra-nodal mass.
Outcome measures
| Measure |
Idelalisib 150 mg BID
n=18 Participants
Participants received idelalisib 150 mg tablets, orally, BID, continuously for up to maximum 33.5 months.
|
Idelalisib 100 mg BID
n=12 Participants
Participants received idelalisib 100 mg tablets, orally, BID, continuously for up to maximum 63.6 months.
|
Idelalisib 150 mg BID INT
n=9 Participants
Participants received idelalisib 150 mg tablets, orally, BID for 21 days and 7 days off-treatment (INT dosing schedule) in each 28-day cycle for up to maximum of 24.6 months.
|
|---|---|---|---|
|
Duration of Response (DOR)
|
27.1 months
Interval 7.7 to
The upper limit of 95% confidence interval (CI) was not estimable due to insufficient number of events.
|
18.0 months
Interval 2.7 to
The upper limit of 95% CI was not estimable due to insufficient number of events.
|
5.7 months
Interval 0.3 to
The upper limit of 95% CI was not estimable due to insufficient number of events.
|
SECONDARY outcome
Timeframe: First dose date up to Week 24Population: Participants in the ITT analysis set were analyzed.
ORR by Week 24 is defined as the percentage of participants who achieve a PR or CR by Week 24. PR criteria: No evidence of new disease, a 50% decrease from baseline in SPD of index lesions, no increase in non-index disease, no increase in liver/spleen size and no new liver/spleen enlargement. CR criteria: No evidence of new disease, regression of all index nodal lesions to normal size (≤1.5 cm in LD for large nodes and ≤1.0 cm in LD, ≤1.0 cm in LPD for small nodes), regression to normal of all nodal non-index disease, disappearance of all detectable extra-nodal index and non-index disease, normal spleen and liver size, no new liver/spleen enlargement, morphologically negative bone marrow.
Outcome measures
| Measure |
Idelalisib 150 mg BID
n=47 Participants
Participants received idelalisib 150 mg tablets, orally, BID, continuously for up to maximum 33.5 months.
|
Idelalisib 100 mg BID
n=27 Participants
Participants received idelalisib 100 mg tablets, orally, BID, continuously for up to maximum 63.6 months.
|
Idelalisib 150 mg BID INT
n=22 Participants
Participants received idelalisib 150 mg tablets, orally, BID for 21 days and 7 days off-treatment (INT dosing schedule) in each 28-day cycle for up to maximum of 24.6 months.
|
|---|---|---|---|
|
Overall Response Rate (ORR) by Week 24
|
36.2 percentage of participants
Interval 22.7 to 51.5
|
33.3 percentage of participants
Interval 16.5 to 54.0
|
27.3 percentage of participants
Interval 10.7 to 50.2
|
SECONDARY outcome
Timeframe: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)Population: Participants in the safety analysis set were analyzed.
TEAEs were defined as 1 or both of any AEs leading to premature discontinuation of study drug, or any AEs with an onset date on or after the study drug start date and no later than the last exposure date after permanent discontinuation of the study drug. TEAEs severity was graded according to the NCI CTCAE version 5.0. Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening; Grade 5: Fatal. Participants are counted at the highest AE grade experienced.
Outcome measures
| Measure |
Idelalisib 150 mg BID
n=47 Participants
Participants received idelalisib 150 mg tablets, orally, BID, continuously for up to maximum 33.5 months.
|
Idelalisib 100 mg BID
n=27 Participants
Participants received idelalisib 100 mg tablets, orally, BID, continuously for up to maximum 63.6 months.
|
Idelalisib 150 mg BID INT
n=21 Participants
Participants received idelalisib 150 mg tablets, orally, BID for 21 days and 7 days off-treatment (INT dosing schedule) in each 28-day cycle for up to maximum of 24.6 months.
|
|---|---|---|---|
|
Number of Participants With Any TEAE, Grade 3 or Higher TEAEs, Serious TEAEs, Idelalisib-related TEAEs, TEAEs Leading to Interruption or Discontinuation of Idelalisib
Any TEAE
|
45 Participants
|
26 Participants
|
19 Participants
|
|
Number of Participants With Any TEAE, Grade 3 or Higher TEAEs, Serious TEAEs, Idelalisib-related TEAEs, TEAEs Leading to Interruption or Discontinuation of Idelalisib
Grade 3 or Higher TEAEs
|
41 Participants
|
25 Participants
|
12 Participants
|
|
Number of Participants With Any TEAE, Grade 3 or Higher TEAEs, Serious TEAEs, Idelalisib-related TEAEs, TEAEs Leading to Interruption or Discontinuation of Idelalisib
Serious TEAEs
|
31 Participants
|
19 Participants
|
11 Participants
|
|
Number of Participants With Any TEAE, Grade 3 or Higher TEAEs, Serious TEAEs, Idelalisib-related TEAEs, TEAEs Leading to Interruption or Discontinuation of Idelalisib
Idelalisib-related TEAEs
|
38 Participants
|
25 Participants
|
11 Participants
|
|
Number of Participants With Any TEAE, Grade 3 or Higher TEAEs, Serious TEAEs, Idelalisib-related TEAEs, TEAEs Leading to Interruption or Discontinuation of Idelalisib
TEAEs Leading to Interruption of Idelalisib
|
32 Participants
|
18 Participants
|
6 Participants
|
|
Number of Participants With Any TEAE, Grade 3 or Higher TEAEs, Serious TEAEs, Idelalisib-related TEAEs, TEAEs Leading to Interruption or Discontinuation of Idelalisib
TEAEs Leading to Discontinuation of Idelalisib
|
28 Participants
|
13 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)Population: Participants in the safety analysis set with available data were analyzed.
Treatment-emergent laboratory abnormality was defined as an increase of at least 1 toxicity grade from baseline at any time postbaseline up to and including the date of last study drug dose plus 30 days. Laboratory abnormalities included hematology and serum chemistry parameters. Clinically significant laboratory abnormalities were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for severity as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), or Grade 4 (life threatening). The number of participants with any post-baseline abnormal laboratory value in Grade 1-4 categories are reported.
Outcome measures
| Measure |
Idelalisib 150 mg BID
n=47 Participants
Participants received idelalisib 150 mg tablets, orally, BID, continuously for up to maximum 33.5 months.
|
Idelalisib 100 mg BID
n=27 Participants
Participants received idelalisib 100 mg tablets, orally, BID, continuously for up to maximum 63.6 months.
|
Idelalisib 150 mg BID INT
n=20 Participants
Participants received idelalisib 150 mg tablets, orally, BID for 21 days and 7 days off-treatment (INT dosing schedule) in each 28-day cycle for up to maximum of 24.6 months.
|
|---|---|---|---|
|
Number of Participants With Clinically Significant Treatment-Emergent Laboratory Abnormalities
Hematology: Grade 1
|
7 Participants
|
5 Participants
|
2 Participants
|
|
Number of Participants With Clinically Significant Treatment-Emergent Laboratory Abnormalities
Hematology: Grade 2
|
12 Participants
|
7 Participants
|
5 Participants
|
|
Number of Participants With Clinically Significant Treatment-Emergent Laboratory Abnormalities
Hematology: Grade 3
|
15 Participants
|
11 Participants
|
5 Participants
|
|
Number of Participants With Clinically Significant Treatment-Emergent Laboratory Abnormalities
Hematology: Grade 4
|
6 Participants
|
3 Participants
|
2 Participants
|
|
Number of Participants With Clinically Significant Treatment-Emergent Laboratory Abnormalities
Serum Chemistry: Grade 1
|
9 Participants
|
5 Participants
|
8 Participants
|
|
Number of Participants With Clinically Significant Treatment-Emergent Laboratory Abnormalities
Serum Chemistry: Grade 2
|
17 Participants
|
8 Participants
|
4 Participants
|
|
Number of Participants With Clinically Significant Treatment-Emergent Laboratory Abnormalities
Serum Chemistry: Grade 3
|
10 Participants
|
11 Participants
|
6 Participants
|
|
Number of Participants With Clinically Significant Treatment-Emergent Laboratory Abnormalities
Serum Chemistry: Grade 4
|
7 Participants
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)Population: AEIs data was not collected for analysis.
Time to onset of AEIs is defined as the interval (in months) from the start of idelalisib treatment to the first documentation of start of AEI. AEIs included grade ≥ 3 diarrhea/colitis, rash, febrile neutropenia, infection, and any grade of: Pneumonitis, bowel perforation, progressive multifocal leukoencephalopathy (PML), Pneumocystis jirovecii pneumonia (PJP), cytomegalovirus (CMV) infection, and organizing pneumonia.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Randomization up to PD or death from any cause (maximum duration: 73.5 months)Population: Participants in the ITT analysis set were analyzed.
PFS is defined as the interval (in months) from randomization to the earlier of the first documentation of PD by IRC or death from any cause. PD criteria: New node of \>1.5 cm or \>1.0 cm to ≤1.5 cm in LD, \>1.0 cm in LPD, new/unequivocal reappearance of resolved extra-nodal lesion, new non-index disease, increase by 50% in SPD of index lesions, LD of individual node/extra-nodal mass.
Outcome measures
| Measure |
Idelalisib 150 mg BID
n=47 Participants
Participants received idelalisib 150 mg tablets, orally, BID, continuously for up to maximum 33.5 months.
|
Idelalisib 100 mg BID
n=27 Participants
Participants received idelalisib 100 mg tablets, orally, BID, continuously for up to maximum 63.6 months.
|
Idelalisib 150 mg BID INT
n=22 Participants
Participants received idelalisib 150 mg tablets, orally, BID for 21 days and 7 days off-treatment (INT dosing schedule) in each 28-day cycle for up to maximum of 24.6 months.
|
|---|---|---|---|
|
Progression-Free Survival (PFS)
|
9.8 months
Interval 5.5 to 28.7
|
19.4 months
Interval 13.9 to 23.3
|
8.3 months
Interval 2.9 to 8.7
|
SECONDARY outcome
Timeframe: Randomization up to death from any cause (maximum duration: 73.5 months)Population: Participants in the ITT analysis set were analyzed.
OS is defined as the interval (in months) from randomization to death from any cause.
Outcome measures
| Measure |
Idelalisib 150 mg BID
n=47 Participants
Participants received idelalisib 150 mg tablets, orally, BID, continuously for up to maximum 33.5 months.
|
Idelalisib 100 mg BID
n=27 Participants
Participants received idelalisib 100 mg tablets, orally, BID, continuously for up to maximum 63.6 months.
|
Idelalisib 150 mg BID INT
n=22 Participants
Participants received idelalisib 150 mg tablets, orally, BID for 21 days and 7 days off-treatment (INT dosing schedule) in each 28-day cycle for up to maximum of 24.6 months.
|
|---|---|---|---|
|
Overall Survival (OS)
|
28.7 months
Interval 14.0 to
The upper limit of 95% CI was not estimable due to insufficient number of events.
|
NA months
Interval 23.3 to
Median and upper limit of 95% CI were not estimable due to insufficient number of events.
|
NA months
Interval 13.9 to
Median and upper limit of 95% CI were not estimable due to insufficient number of events.
|
SECONDARY outcome
Timeframe: Predose on Day 1, Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 32, and 48Population: Pharmacokinetic (PK) analysis set included participants who received at least 1 dose of study drug and had at least 1 sample with detectable drug concentration. Participants in the PK analysis set with available data were analyzed.
Outcome measures
| Measure |
Idelalisib 150 mg BID
n=44 Participants
Participants received idelalisib 150 mg tablets, orally, BID, continuously for up to maximum 33.5 months.
|
Idelalisib 100 mg BID
n=27 Participants
Participants received idelalisib 100 mg tablets, orally, BID, continuously for up to maximum 63.6 months.
|
Idelalisib 150 mg BID INT
n=21 Participants
Participants received idelalisib 150 mg tablets, orally, BID for 21 days and 7 days off-treatment (INT dosing schedule) in each 28-day cycle for up to maximum of 24.6 months.
|
|---|---|---|---|
|
Trough Plasma Concentration of Idelalisib
Week 24
|
460.74 nanograms per milliliter (ng/ml)
Standard Deviation 321.766
|
728.76 nanograms per milliliter (ng/ml)
Standard Deviation 760.391
|
NA nanograms per milliliter (ng/ml)
Standard Deviation NA
Mean and SD were not available as the values were below the level of quantitation.
|
|
Trough Plasma Concentration of Idelalisib
Week 32
|
446.13 nanograms per milliliter (ng/ml)
Standard Deviation 450.821
|
388.58 nanograms per milliliter (ng/ml)
Standard Deviation 351.293
|
352.73 nanograms per milliliter (ng/ml)
Standard Deviation 875.923
|
|
Trough Plasma Concentration of Idelalisib
Week 48
|
706.13 nanograms per milliliter (ng/ml)
Standard Deviation 580.022
|
552.13 nanograms per milliliter (ng/ml)
Standard Deviation 571.081
|
165.00 nanograms per milliliter (ng/ml)
Standard Deviation 368.951
|
|
Trough Plasma Concentration of Idelalisib
Day 1
|
NA nanograms per milliliter (ng/ml)
Standard Deviation NA
Mean and Standard Deviation (SD) were not available as the values were below the level of quantitation.
|
NA nanograms per milliliter (ng/ml)
Standard Deviation NA
Mean and SD were not available as the values were below the level of quantitation.
|
NA nanograms per milliliter (ng/ml)
Standard Deviation NA
Mean and SD were not available as the values were below the level of quantitation.
|
|
Trough Plasma Concentration of Idelalisib
Week 2
|
683.68 nanograms per milliliter (ng/ml)
Standard Deviation 514.166
|
382.94 nanograms per milliliter (ng/ml)
Standard Deviation 352.842
|
636.35 nanograms per milliliter (ng/ml)
Standard Deviation 461.042
|
|
Trough Plasma Concentration of Idelalisib
Week 4
|
623.64 nanograms per milliliter (ng/ml)
Standard Deviation 466.557
|
447.78 nanograms per milliliter (ng/ml)
Standard Deviation 356.971
|
94.14 nanograms per milliliter (ng/ml)
Standard Deviation 231.647
|
|
Trough Plasma Concentration of Idelalisib
Week 6
|
581.20 nanograms per milliliter (ng/ml)
Standard Deviation 470.988
|
361.90 nanograms per milliliter (ng/ml)
Standard Deviation 248.996
|
596.80 nanograms per milliliter (ng/ml)
Standard Deviation 401.619
|
|
Trough Plasma Concentration of Idelalisib
Week 8
|
655.16 nanograms per milliliter (ng/ml)
Standard Deviation 498.873
|
430.33 nanograms per milliliter (ng/ml)
Standard Deviation 477.877
|
77.66 nanograms per milliliter (ng/ml)
Standard Deviation 274.313
|
|
Trough Plasma Concentration of Idelalisib
Week 10
|
616.05 nanograms per milliliter (ng/ml)
Standard Deviation 370.862
|
356.12 nanograms per milliliter (ng/ml)
Standard Deviation 372.557
|
387.40 nanograms per milliliter (ng/ml)
Standard Deviation 314.249
|
|
Trough Plasma Concentration of Idelalisib
Week 12
|
630.56 nanograms per milliliter (ng/ml)
Standard Deviation 664.066
|
389.21 nanograms per milliliter (ng/ml)
Standard Deviation 466.104
|
272.44 nanograms per milliliter (ng/ml)
Standard Deviation 626.451
|
|
Trough Plasma Concentration of Idelalisib
Week 16
|
729.23 nanograms per milliliter (ng/ml)
Standard Deviation 832.158
|
730.29 nanograms per milliliter (ng/ml)
Standard Deviation 936.798
|
111.67 nanograms per milliliter (ng/ml)
Standard Deviation 296.666
|
|
Trough Plasma Concentration of Idelalisib
Week 20
|
525.91 nanograms per milliliter (ng/ml)
Standard Deviation 411.330
|
745.58 nanograms per milliliter (ng/ml)
Standard Deviation 841.105
|
107.34 nanograms per milliliter (ng/ml)
Standard Deviation 269.434
|
SECONDARY outcome
Timeframe: 1.5 hours postdose on Day 1, Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 32, and 48Population: Participants in the PK analysis set with available data were analyzed.
Outcome measures
| Measure |
Idelalisib 150 mg BID
n=43 Participants
Participants received idelalisib 150 mg tablets, orally, BID, continuously for up to maximum 33.5 months.
|
Idelalisib 100 mg BID
n=27 Participants
Participants received idelalisib 100 mg tablets, orally, BID, continuously for up to maximum 63.6 months.
|
Idelalisib 150 mg BID INT
n=20 Participants
Participants received idelalisib 150 mg tablets, orally, BID for 21 days and 7 days off-treatment (INT dosing schedule) in each 28-day cycle for up to maximum of 24.6 months.
|
|---|---|---|---|
|
Peak Plasma Concentration of Idelalisib
Day 1
|
2626.12 ng/ml
Standard Deviation 1330.290
|
1575.81 ng/ml
Standard Deviation 803.317
|
2221.35 ng/ml
Standard Deviation 1621.291
|
|
Peak Plasma Concentration of Idelalisib
Week 2
|
2306.12 ng/ml
Standard Deviation 810.433
|
1520.29 ng/ml
Standard Deviation 675.089
|
2186.89 ng/ml
Standard Deviation 1265.850
|
|
Peak Plasma Concentration of Idelalisib
Week 4
|
2353.95 ng/ml
Standard Deviation 930.754
|
1528.48 ng/ml
Standard Deviation 759.936
|
2608.12 ng/ml
Standard Deviation 1009.937
|
|
Peak Plasma Concentration of Idelalisib
Week 6
|
2433.33 ng/ml
Standard Deviation 1092.969
|
1682.52 ng/ml
Standard Deviation 939.455
|
2341.33 ng/ml
Standard Deviation 948.133
|
|
Peak Plasma Concentration of Idelalisib
Week 8
|
2207.59 ng/ml
Standard Deviation 980.606
|
1649.25 ng/ml
Standard Deviation 940.683
|
2786.43 ng/ml
Standard Deviation 1591.408
|
|
Peak Plasma Concentration of Idelalisib
Week 10
|
2435.00 ng/ml
Standard Deviation 1027.469
|
1601.11 ng/ml
Standard Deviation 804.605
|
2380.00 ng/ml
Standard Deviation 1118.679
|
|
Peak Plasma Concentration of Idelalisib
Week 12
|
2328.13 ng/ml
Standard Deviation 1141.764
|
1658.89 ng/ml
Standard Deviation 837.159
|
2316.20 ng/ml
Standard Deviation 1391.815
|
|
Peak Plasma Concentration of Idelalisib
Week 16
|
2634.39 ng/ml
Standard Deviation 1323.611
|
1756.37 ng/ml
Standard Deviation 826.784
|
2372.50 ng/ml
Standard Deviation 1335.420
|
|
Peak Plasma Concentration of Idelalisib
Week 20
|
2354.26 ng/ml
Standard Deviation 1440.587
|
1925.29 ng/ml
Standard Deviation 776.516
|
2177.69 ng/ml
Standard Deviation 1417.505
|
|
Peak Plasma Concentration of Idelalisib
Week 24
|
2058.47 ng/ml
Standard Deviation 905.071
|
1914.65 ng/ml
Standard Deviation 1151.998
|
1906.30 ng/ml
Standard Deviation 1099.458
|
|
Peak Plasma Concentration of Idelalisib
Week 32
|
2009.71 ng/ml
Standard Deviation 1231.296
|
2028.00 ng/ml
Standard Deviation 593.236
|
1825.00 ng/ml
Standard Deviation 947.892
|
|
Peak Plasma Concentration of Idelalisib
Week 48
|
2655.13 ng/ml
Standard Deviation 1348.957
|
1448.33 ng/ml
Standard Deviation 650.798
|
1312.00 ng/ml
Standard Deviation 850.894
|
Adverse Events
Idelalisib 150 mg BID
Serious events: 31 serious events
Other events: 44 other events
Deaths: 20 deaths
Idelalisib 100 mg BID
Serious events: 19 serious events
Other events: 24 other events
Deaths: 12 deaths
Idelalisib 150 mg BID INT
Serious events: 11 serious events
Other events: 16 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
Idelalisib 150 mg BID
n=47 participants at risk
Participants received idelalisib 150 mg tablets, orally, BID, continuously for up to maximum 33.5 months.
|
Idelalisib 100 mg BID
n=27 participants at risk
Participants received idelalisib 100 mg tablets, orally, BID, continuously for up to maximum 63.6 months.
|
Idelalisib 150 mg BID INT
n=21 participants at risk
Participants received idelalisib 150 mg tablets, orally, BID for 21 days and 7 days off-treatment (INT dosing schedule) in each 28-day cycle for up to maximum of 24.6 months.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
4.3%
2/47 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
0.00%
0/27 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
4.8%
1/21 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.1%
1/47 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
7.4%
2/27 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
0.00%
0/21 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.1%
1/47 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
0.00%
0/27 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
0.00%
0/21 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Atrial flutter
|
2.1%
1/47 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
0.00%
0/27 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
0.00%
0/21 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
|
Endocrine disorders
Hypercalcaemia of malignancy
|
2.1%
1/47 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
0.00%
0/27 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
0.00%
0/21 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
|
Eye disorders
Visual field defect
|
2.1%
1/47 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
0.00%
0/27 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
0.00%
0/21 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Colitis
|
6.4%
3/47 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
0.00%
0/27 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
0.00%
0/21 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
14.9%
7/47 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
22.2%
6/27 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
0.00%
0/21 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
|
General disorders
Facial pain
|
2.1%
1/47 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
0.00%
0/27 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
0.00%
0/21 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
|
General disorders
Generalised oedema
|
0.00%
0/47 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
3.7%
1/27 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
0.00%
0/21 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
|
General disorders
Pyrexia
|
2.1%
1/47 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
0.00%
0/27 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
4.8%
1/21 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
2.1%
1/47 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
0.00%
0/27 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
0.00%
0/21 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Hepatotoxicity
|
4.3%
2/47 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
0.00%
0/27 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
0.00%
0/21 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
|
Immune system disorders
Drug hypersensitivity
|
2.1%
1/47 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
0.00%
0/27 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
0.00%
0/21 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Abdominal infection
|
0.00%
0/47 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
0.00%
0/27 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
4.8%
1/21 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Aspergillus infection
|
2.1%
1/47 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
0.00%
0/27 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
0.00%
0/21 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/47 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
3.7%
1/27 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
0.00%
0/21 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Coronavirus pneumonia
|
2.1%
1/47 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
0.00%
0/27 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
0.00%
0/21 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Covid-19
|
2.1%
1/47 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
3.7%
1/27 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
9.5%
2/21 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Covid-19 pneumonia
|
2.1%
1/47 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
0.00%
0/27 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
4.8%
1/21 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Cytomegalovirus infection
|
2.1%
1/47 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
0.00%
0/27 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
0.00%
0/21 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Infection
|
2.1%
1/47 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
0.00%
0/27 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
0.00%
0/21 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Neutropenic sepsis
|
0.00%
0/47 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
0.00%
0/27 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
4.8%
1/21 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Oesophageal candidiasis
|
0.00%
0/47 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
3.7%
1/27 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
0.00%
0/21 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Pneumonia
|
2.1%
1/47 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
7.4%
2/27 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
4.8%
1/21 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Pneumonia bacterial
|
2.1%
1/47 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
0.00%
0/27 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
0.00%
0/21 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Pneumonia haemophilus
|
2.1%
1/47 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
0.00%
0/27 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
0.00%
0/21 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Respiratory tract infection
|
2.1%
1/47 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
0.00%
0/27 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
0.00%
0/21 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Sepsis
|
0.00%
0/47 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
3.7%
1/27 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
4.8%
1/21 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Suspected COVID-19
|
0.00%
0/47 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
3.7%
1/27 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
0.00%
0/21 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
2.1%
1/47 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
0.00%
0/27 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
0.00%
0/21 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/47 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
3.7%
1/27 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
0.00%
0/21 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/47 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
3.7%
1/27 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
0.00%
0/21 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/47 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
3.7%
1/27 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
0.00%
0/21 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
|
Investigations
General physical condition abnormal
|
2.1%
1/47 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
0.00%
0/27 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
0.00%
0/21 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
|
Investigations
International normalised ratio increased
|
0.00%
0/47 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
3.7%
1/27 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
0.00%
0/21 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
|
Investigations
Klebsiella test positive
|
0.00%
0/47 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
3.7%
1/27 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
0.00%
0/21 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
4.3%
2/47 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
0.00%
0/27 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
0.00%
0/21 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/47 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
3.7%
1/27 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
0.00%
0/21 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/47 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
3.7%
1/27 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
0.00%
0/21 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
2.1%
1/47 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
0.00%
0/27 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
0.00%
0/21 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Mobility decreased
|
0.00%
0/47 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
3.7%
1/27 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
0.00%
0/21 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/47 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
3.7%
1/27 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
0.00%
0/21 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.00%
0/47 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
3.7%
1/27 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
0.00%
0/21 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
2.1%
1/47 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
0.00%
0/27 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
0.00%
0/21 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/47 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
0.00%
0/27 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
4.8%
1/21 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Cerebrovascular accident
|
2.1%
1/47 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
0.00%
0/27 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
4.8%
1/21 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/47 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
14.8%
4/27 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
0.00%
0/21 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Haematuria
|
2.1%
1/47 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
0.00%
0/27 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
0.00%
0/21 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/47 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
0.00%
0/27 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
4.8%
1/21 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Renal failure
|
2.1%
1/47 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
0.00%
0/27 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
0.00%
0/21 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Renal impairment
|
2.1%
1/47 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
0.00%
0/27 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
0.00%
0/21 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.1%
1/47 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
0.00%
0/27 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
0.00%
0/21 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.00%
0/47 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
3.7%
1/27 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
0.00%
0/21 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/47 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
0.00%
0/27 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
4.8%
1/21 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.1%
1/47 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
0.00%
0/27 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
0.00%
0/21 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.1%
1/47 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
0.00%
0/27 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
4.8%
1/21 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/47 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
3.7%
1/27 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
0.00%
0/21 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Stevens-Johnson syndrome
|
2.1%
1/47 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
0.00%
0/27 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
0.00%
0/21 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Hypotension
|
2.1%
1/47 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
0.00%
0/27 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
0.00%
0/21 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
Other adverse events
| Measure |
Idelalisib 150 mg BID
n=47 participants at risk
Participants received idelalisib 150 mg tablets, orally, BID, continuously for up to maximum 33.5 months.
|
Idelalisib 100 mg BID
n=27 participants at risk
Participants received idelalisib 100 mg tablets, orally, BID, continuously for up to maximum 63.6 months.
|
Idelalisib 150 mg BID INT
n=21 participants at risk
Participants received idelalisib 150 mg tablets, orally, BID for 21 days and 7 days off-treatment (INT dosing schedule) in each 28-day cycle for up to maximum of 24.6 months.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
21.3%
10/47 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
11.1%
3/27 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
9.5%
2/21 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/47 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
7.4%
2/27 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
0.00%
0/21 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Neutropenia
|
25.5%
12/47 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
37.0%
10/27 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
19.0%
4/21 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
12.8%
6/47 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
11.1%
3/27 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
0.00%
0/21 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
10.6%
5/47 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
7.4%
2/27 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
9.5%
2/21 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Colitis
|
6.4%
3/47 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
3.7%
1/27 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
0.00%
0/21 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
12.8%
6/47 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
14.8%
4/27 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
9.5%
2/21 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
40.4%
19/47 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
44.4%
12/27 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
28.6%
6/21 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
10.6%
5/47 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
22.2%
6/27 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
19.0%
4/21 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
8.5%
4/47 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
18.5%
5/27 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
4.8%
1/21 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
|
General disorders
Asthenia
|
8.5%
4/47 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
14.8%
4/27 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
14.3%
3/21 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
|
General disorders
Fatigue
|
10.6%
5/47 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
7.4%
2/27 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
9.5%
2/21 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
|
General disorders
Oedema peripheral
|
10.6%
5/47 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
7.4%
2/27 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
14.3%
3/21 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
|
General disorders
Pyrexia
|
23.4%
11/47 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
22.2%
6/27 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
14.3%
3/21 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Bronchitis
|
4.3%
2/47 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
3.7%
1/27 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
9.5%
2/21 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Covid-19
|
2.1%
1/47 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
3.7%
1/27 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
9.5%
2/21 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Influenza
|
6.4%
3/47 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
0.00%
0/27 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
0.00%
0/21 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Oral candidiasis
|
8.5%
4/47 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
0.00%
0/27 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
4.8%
1/21 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Respiratory tract infection
|
6.4%
3/47 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
0.00%
0/27 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
4.8%
1/21 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
6.4%
3/47 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
14.8%
4/27 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
0.00%
0/21 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
6.4%
3/47 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
14.8%
4/27 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
9.5%
2/21 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
|
Investigations
Alanine aminotransferase increased
|
19.1%
9/47 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
18.5%
5/27 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
0.00%
0/21 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
17.0%
8/47 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
22.2%
6/27 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
0.00%
0/21 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
|
Investigations
Transaminases increased
|
2.1%
1/47 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
0.00%
0/27 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
9.5%
2/21 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
|
Investigations
Weight decreased
|
8.5%
4/47 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
11.1%
3/27 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
0.00%
0/21 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
10.6%
5/47 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
7.4%
2/27 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
4.8%
1/21 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
6.4%
3/47 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
7.4%
2/27 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
9.5%
2/21 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.5%
4/47 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
14.8%
4/27 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
4.8%
1/21 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
2.1%
1/47 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
0.00%
0/27 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
14.3%
3/21 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/47 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
3.7%
1/27 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
9.5%
2/21 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
6.4%
3/47 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
7.4%
2/27 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
4.8%
1/21 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/47 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
7.4%
2/27 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
4.8%
1/21 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
17.0%
8/47 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
14.8%
4/27 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
0.00%
0/21 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
2.1%
1/47 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
3.7%
1/27 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
9.5%
2/21 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
6.4%
3/47 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
0.00%
0/27 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
0.00%
0/21 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
2.1%
1/47 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
7.4%
2/27 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
0.00%
0/21 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
23.4%
11/47 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
14.8%
4/27 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
28.6%
6/21 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/47 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
0.00%
0/27 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
9.5%
2/21 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Hypertension
|
10.6%
5/47 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
7.4%
2/27 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
|
0.00%
0/21 • All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified. Adverse Events: Safety analysis set included all participants who received at least 1 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