Trial Outcomes & Findings for Efficacy and Safety Study of bb2121 in Subjects With Relapsed and Refractory Multiple Myeloma (NCT NCT03361748)
NCT ID: NCT03361748
Last Updated: 2025-05-23
Results Overview
Number of participants who achieved partial response (PR) or better according to IMWG Uniform Response Criteria for Multiple Myeloma as assessed by an independent response committee (IRC).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
149 participants
Primary outcome timeframe
From first dose to 24 Months
Results posted on
2025-05-23
Participant Flow
137 participants treated
Participant milestones
| Measure |
BB2121
BB2121
|
|---|---|
|
Overall Study
STARTED
|
137
|
|
Overall Study
COMPLETED
|
36
|
|
Overall Study
NOT COMPLETED
|
101
|
Reasons for withdrawal
| Measure |
BB2121
BB2121
|
|---|---|
|
Overall Study
Death
|
77
|
|
Overall Study
Lost to Follow-up
|
4
|
|
Overall Study
Withdrawal by Subject
|
20
|
Baseline Characteristics
Efficacy and Safety Study of bb2121 in Subjects With Relapsed and Refractory Multiple Myeloma
Baseline characteristics by cohort
| Measure |
BB2121
n=137 Participants
BB2121
|
|---|---|
|
Age, Continuous
|
59.4 Years
STANDARD_DEVIATION 9.53 • n=5 Participants
|
|
Sex: Female, Male
Female
|
54 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
83 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
112 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
103 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
16 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From first dose to 24 MonthsPopulation: All Treated Participants
Number of participants who achieved partial response (PR) or better according to IMWG Uniform Response Criteria for Multiple Myeloma as assessed by an independent response committee (IRC).
Outcome measures
| Measure |
BB2121
n=137 Participants
BB2121
|
|---|---|
|
Overall Response Rate
|
74.5 Percentage of Participants
Interval 67.1 to 81.8
|
SECONDARY outcome
Timeframe: From first dose to 24 MonthsPopulation: All Treated Participants
Percentage of participants who achieved CR or sCR according to IMWG Uniform Response Criteria for Multiple Myeloma as assessed by an IRC.
Outcome measures
| Measure |
BB2121
n=137 Participants
BB2121
|
|---|---|
|
Complete Response Rate
|
34.3 Percentage of participants
Interval 26.4 to 42.3
|
SECONDARY outcome
Timeframe: From first dose to initial response (approximately on average 1.2 months, max of 8.8 months)Population: All Treated Participants with a CR or PR as per IRC
Time from first bb2121 infusion to first documentation of response of PR or better.
Outcome measures
| Measure |
BB2121
n=102 Participants
BB2121
|
|---|---|
|
Time to Response
|
1.0 Months
Interval 0.5 to 8.8
|
SECONDARY outcome
Timeframe: From first dose to 24 months after first dosePopulation: All Treated Participants with a CR or PR as per IRC
Time from first documentation of response or PR or better to first documentation of disease progression or death from any cause, whichever occurs first.
Outcome measures
| Measure |
BB2121
n=102 Participants
BB2121
|
|---|---|
|
Duration of Response
|
11.04 Months
Interval 9.92 to 12.52
|
SECONDARY outcome
Timeframe: From first dose to 24 months after first dosePopulation: All Treated Population
Time from first bb2121 infusion to first documentation of progressive disease (PD), or death due to any cause, whichever occurs first.
Outcome measures
| Measure |
BB2121
n=137 Participants
BB2121
|
|---|---|
|
Progression Free Survival (PFS)
|
8.90 Months
Interval 6.01 to 11.86
|
SECONDARY outcome
Timeframe: From first dose to 24 months after first dosePopulation: All Treated Population
Time from first bb2121 infusion to first documentation of progressive disease (PD), or death due to any cause, whichever occurs first.
Outcome measures
| Measure |
BB2121
n=137 Participants
BB2121
|
|---|---|
|
Time to Progression (TTP)
|
10.38 Months
Interval 6.11 to 12.06
|
SECONDARY outcome
Timeframe: From screening to the end of follow up (approximately 5 years and 2 months)Population: All Treated Population
Time from first bb2121 infusion to time of death due to any cause.
Outcome measures
| Measure |
BB2121
n=137 Participants
BB2121
|
|---|---|
|
Overall Survival
|
28.25 Months
Interval 20.21 to 38.08
|
SECONDARY outcome
Timeframe: From screening to the end of follow up (approximately 5 years and 2 months)Population: All Treated Participants
Number of participants with adverse events (AEs), adverse events of special interest (AESI), serious adverse events (SAEs), cytokine release syndrome, neurotoxicity, infection and clinically signifcant laboratory abnormalities.
Outcome measures
| Measure |
BB2121
n=137 Participants
BB2121
|
|---|---|
|
Number of Participants With Safety Related Events
Any Grade AE
|
137 Participants
|
|
Number of Participants With Safety Related Events
Grade 3 or 4 AE
|
136 Participants
|
|
Number of Participants With Safety Related Events
SAEs
|
98 Participants
|
|
Number of Participants With Safety Related Events
AEs of Special Interest
|
136 Participants
|
|
Number of Participants With Safety Related Events
Cytokine Release Syndrome
|
116 Participants
|
|
Number of Participants With Safety Related Events
Neurotoxicity
|
53 Participants
|
|
Number of Participants With Safety Related Events
Infections
|
95 Participants
|
|
Number of Participants With Safety Related Events
Clinically Significant Laboratory Abnormalities
|
0 Participants
|
SECONDARY outcome
Timeframe: From first dose to the end of follow up (Approximately 5 years)Population: PK Evaluable Population
Cmax is defined as the maximum transgene level at Tmax Tmax: The time of maximum observed transgene level, obtained directly from the observed transgene level - time.
Outcome measures
| Measure |
BB2121
n=136 Participants
BB2121
|
|---|---|
|
Cmax
Total
|
388150.65 transgene copies/ug of genomic DNA
Standard Deviation 372280.64
|
|
Cmax
450x10^6 cells
|
449826.92 transgene copies/ug of genomic DNA
Standard Deviation 375293.18
|
|
Cmax
300x10^6 cells
|
335916.20 transgene copies/ug of genomic DNA
Standard Deviation 369546.39
|
|
Cmax
150x10^6 cells
|
317793.50 transgene copies/ug of genomic DNA
Standard Deviation 284926.30
|
SECONDARY outcome
Timeframe: at 9 months post first dose (Approximtately 9 Months)Population: PK Evaluable Population for AUC at 9 Months
The AUC of the transgene level from the time of dosing to 9 months
Outcome measures
| Measure |
BB2121
n=122 Participants
BB2121
|
|---|---|
|
AUC 0-9M
450x10^6 cells
|
10599751.18 copies*days/ug
Standard Deviation 10833877.42
|
|
AUC 0-9M
300x10^6 cells
|
6604279.35 copies*days/ug
Standard Deviation 8523928.48
|
|
AUC 0-9M
150x10^6 cells
|
10555200.59 copies*days/ug
Standard Deviation 13555457.13
|
|
AUC 0-9M
Total
|
8634034.70 copies*days/ug
Standard Deviation 9909488.82
|
SECONDARY outcome
Timeframe: From first dose to the end of follow up (Approximately 5 years)Population: PK Evaluable Population
Tmax: The time of maximum observed transgene level, obtained directly from the observed transgene level - time.
Outcome measures
| Measure |
BB2121
n=136 Participants
BB2121
|
|---|---|
|
Tmax
Total
|
12.07 Days
Standard Deviation 4.114
|
|
Tmax
450x10^6 cells
|
12.37 Days
Standard Deviation 4.513
|
|
Tmax
300x10^6 cells
|
11.74 Days
Standard Deviation 3.830
|
|
Tmax
150x10^6 cells
|
13.25 Days
Standard Deviation 1.500
|
SECONDARY outcome
Timeframe: From first dose to the end of follow up (Approximately 5 years)Population: All Treated Population
Number of Participants with Anti-CAR-Antibodies. Pre-postive is defined by last value before or on bb2121 infusion date is positive Post-positve is defined by at least one positive value post bb2121 infusion.
Outcome measures
| Measure |
BB2121
n=137 Participants
BB2121
|
|---|---|
|
Number of Participants With Anti-CAR-Antibodies
Pre-Positive Pre-positive and post-positive
|
6 Participants
|
|
Number of Participants With Anti-CAR-Antibodies
Pre-Positive Pre-positive and post-negative
|
0 Participants
|
|
Number of Participants With Anti-CAR-Antibodies
Pre-Positive Missing post data
|
0 Participants
|
|
Number of Participants With Anti-CAR-Antibodies
Pre-Negative Pre-negative and post-postive
|
69 Participants
|
|
Number of Participants With Anti-CAR-Antibodies
Pre-Negative Pre-negative and post-negative
|
60 Participants
|
|
Number of Participants With Anti-CAR-Antibodies
Pre-Negative Missing post data
|
1 Participants
|
|
Number of Participants With Anti-CAR-Antibodies
Missing Pre Data Post-positive
|
1 Participants
|
|
Number of Participants With Anti-CAR-Antibodies
Missing Pre Data post-negative
|
0 Participants
|
|
Number of Participants With Anti-CAR-Antibodies
Missing Pre Data missing Post Data
|
0 Participants
|
SECONDARY outcome
Timeframe: From screening to the end of follow up (Approximately 5 years and 2 months)Population: All Treated Population
Percentage of participants who achieved ≥ VGPR and MRD negative status at a sensitivity of 10-⁵ at any time point within 3 months prior to achieving at least VGPR until the time of PD/death. MRD in the bone marrow will be measured using both next generation sequencing (NGS) techniques measuring immunoglobulin gene rearrangements of the malignant clone. MRD will be reported with a sensitivity of 10-⁴, 10-⁵, and 10-⁶ nucleated cells. The primary analysis for MRD negative response will use the sensitivity of 10-⁵. MRD = Minimal Residual Disease PD = Progressive Disease VGPR = Very good partial response.
Outcome measures
| Measure |
BB2121
n=137 Participants
BB2121
|
|---|---|
|
Percentage of Participants Who Achieved >= VGPR and MRD Negative Status
10^(-4) Sensitivity
|
41.6 Percentage of Participants
Interval 33.3 to 50.3
|
|
Percentage of Participants Who Achieved >= VGPR and MRD Negative Status
10^(-5) Sensitivity
|
40.9 Percentage of Participants
Interval 32.6 to 49.6
|
|
Percentage of Participants Who Achieved >= VGPR and MRD Negative Status
10^(-6) Sensitivity
|
24.8 Percentage of Participants
Interval 17.8 to 32.9
|
SECONDARY outcome
Timeframe: At Day 1 and at specific time points up to month 24Population: PRO Analysis Set
Mean change from baseline on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) The QLQ-C30 employs a week recall period for all items. All items will be scored from 0 to 100. The average of the scores will represent the symptoms score. A high score for a symptom scale/item represents a high level of symptomatic problem.
Outcome measures
| Measure |
BB2121
n=126 Participants
BB2121
|
|---|---|
|
Mean Change From Baseline on the EORTC QLQ-C30 - Fatigue.
Day 1
|
4.4 Score on a Scale
Standard Deviation 18.56
|
|
Mean Change From Baseline on the EORTC QLQ-C30 - Fatigue.
Month 1
|
1.1 Score on a Scale
Standard Deviation 24.38
|
|
Mean Change From Baseline on the EORTC QLQ-C30 - Fatigue.
Month 3
|
-10.1 Score on a Scale
Standard Deviation 24.32
|
|
Mean Change From Baseline on the EORTC QLQ-C30 - Fatigue.
Month 6
|
-15.1 Score on a Scale
Standard Deviation 24.39
|
|
Mean Change From Baseline on the EORTC QLQ-C30 - Fatigue.
Month 9
|
-21.5 Score on a Scale
Standard Deviation 24.58
|
|
Mean Change From Baseline on the EORTC QLQ-C30 - Fatigue.
Month 12
|
-16.4 Score on a Scale
Standard Deviation 25.02
|
|
Mean Change From Baseline on the EORTC QLQ-C30 - Fatigue.
Month 18
|
-18.4 Score on a Scale
Standard Deviation 19.10
|
|
Mean Change From Baseline on the EORTC QLQ-C30 - Fatigue.
Month 24
|
-7.9 Score on a Scale
Standard Deviation 15.97
|
SECONDARY outcome
Timeframe: At Day 1 and at specific time points up to month 24Population: PRO Analysis Set
Mean change from baseline on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) The QLQ-C30 employs a week recall period for all items. All items will be scored from 0 to 100. The average of the scores will represent the symptoms score. A high score for a symptom scale/item represents a high level of symptomatic problem.
Outcome measures
| Measure |
BB2121
n=126 Participants
BB2121
|
|---|---|
|
Mean Change From Baseline on the EORTC QLQ-C30 - Pain
Day 1
|
-3.8 Score on a Scale
Standard Deviation 19.46
|
|
Mean Change From Baseline on the EORTC QLQ-C30 - Pain
Month 1
|
-8.9 Score on a Scale
Standard Deviation 26.02
|
|
Mean Change From Baseline on the EORTC QLQ-C30 - Pain
Month 3
|
-12.0 Score on a Scale
Standard Deviation 26.65
|
|
Mean Change From Baseline on the EORTC QLQ-C30 - Pain
Month 6
|
-14.5 Score on a Scale
Standard Deviation 26.15
|
|
Mean Change From Baseline on the EORTC QLQ-C30 - Pain
Month 9
|
-17.5 Score on a Scale
Standard Deviation 24.26
|
|
Mean Change From Baseline on the EORTC QLQ-C30 - Pain
Month 12
|
-17.3 Score on a Scale
Standard Deviation 26.05
|
|
Mean Change From Baseline on the EORTC QLQ-C30 - Pain
Month 18
|
-16.7 Score on a Scale
Standard Deviation 25.39
|
|
Mean Change From Baseline on the EORTC QLQ-C30 - Pain
Month 24
|
-13.1 Score on a Scale
Standard Deviation 16.25
|
SECONDARY outcome
Timeframe: At Day 1 and at specific time points up to month 24Population: PRO Analysis Set
The QLQ-C30 employs a week recall period for all items. All items will be scored from 0 to 100 and an average will be taken. This average is the overall score. A higher scale score represents a higher level of well-being and better ability of daily functioning. Thus, a high score for a functional scale represents a high/healthy level of functioning.
Outcome measures
| Measure |
BB2121
n=126 Participants
BB2121
|
|---|---|
|
Mean Change From Baseline on the EORTC QLQ-C30 - Physical Functioning
Day 1
|
-0.4 Score on a Scale
Standard Deviation 18.13
|
|
Mean Change From Baseline on the EORTC QLQ-C30 - Physical Functioning
Month 1
|
2.1 Score on a Scale
Standard Deviation 22.27
|
|
Mean Change From Baseline on the EORTC QLQ-C30 - Physical Functioning
Month 3
|
9.8 Score on a Scale
Standard Deviation 18.54
|
|
Mean Change From Baseline on the EORTC QLQ-C30 - Physical Functioning
Month 6
|
13.9 Score on a Scale
Standard Deviation 18.47
|
|
Mean Change From Baseline on the EORTC QLQ-C30 - Physical Functioning
Month 9
|
13.1 Score on a Scale
Standard Deviation 19.02
|
|
Mean Change From Baseline on the EORTC QLQ-C30 - Physical Functioning
Month 12
|
13.3 Score on a Scale
Standard Deviation 19.16
|
|
Mean Change From Baseline on the EORTC QLQ-C30 - Physical Functioning
Month 18
|
12.8 Score on a Scale
Standard Deviation 15.99
|
|
Mean Change From Baseline on the EORTC QLQ-C30 - Physical Functioning
Month 24
|
3.8 Score on a Scale
Standard Deviation 13.77
|
SECONDARY outcome
Timeframe: At Day 1 and at specific time points up to month 24Population: PRO Analysis Set
The QLQ-C30 employs a week recall period for all items. All items will be scored from 0 to 100 and an average will be taken. This average is the overall score. A higher scale score represents a higher level of well-being and better ability of daily functioning. Thus, a high score for a functional scale represents a high/healthy level of functioning.
Outcome measures
| Measure |
BB2121
n=126 Participants
BB2121
|
|---|---|
|
Mean Change From Baseline on the EORTC QLQ-C30 - Cognitive Functioning
Day 1
|
-0.4 Score on a Scale
Standard Deviation 16.66
|
|
Mean Change From Baseline on the EORTC QLQ-C30 - Cognitive Functioning
Month 1
|
2.8 Score on a Scale
Standard Deviation 20.10
|
|
Mean Change From Baseline on the EORTC QLQ-C30 - Cognitive Functioning
Month 3
|
5.4 Score on a Scale
Standard Deviation 17.42
|
|
Mean Change From Baseline on the EORTC QLQ-C30 - Cognitive Functioning
Month 6
|
6.4 Score on a Scale
Standard Deviation 16.55
|
|
Mean Change From Baseline on the EORTC QLQ-C30 - Cognitive Functioning
Month 9
|
6.8 Score on a Scale
Standard Deviation 14.88
|
|
Mean Change From Baseline on the EORTC QLQ-C30 - Cognitive Functioning
Month 12
|
4.2 Score on a Scale
Standard Deviation 17.63
|
|
Mean Change From Baseline on the EORTC QLQ-C30 - Cognitive Functioning
Month 18
|
3.8 Score on a Scale
Standard Deviation 19.61
|
|
Mean Change From Baseline on the EORTC QLQ-C30 - Cognitive Functioning
Month 24
|
3.6 Score on a Scale
Standard Deviation 16.25
|
SECONDARY outcome
Timeframe: At Day 1 and at specific time points up to month 24Population: PRO Analysis Set
Mean change from baseline on the EORTC QLQ-C30 The EORTC QLQ-C30 is a 30-item scale composed of both multi-item scales and single-item measures. All of the scales and single-item measures range in score from 0 to 100. A higher scale score represents a higher level of well-being and better ability of daily functioning. Thus, a high score for a functional scale represents a high/healthy level of functioning; a high score for the global health status/HRQoL represents a high HRQoL.
Outcome measures
| Measure |
BB2121
n=126 Participants
BB2121
|
|---|---|
|
Mean Change From Baseline on the EORTC QLQ-C30 - Global Heath/QoL
Day 1
|
-4.7 Score on a Scale
Standard Deviation 17.03
|
|
Mean Change From Baseline on the EORTC QLQ-C30 - Global Heath/QoL
Month 1
|
4.3 Score on a Scale
Standard Deviation 19.95
|
|
Mean Change From Baseline on the EORTC QLQ-C30 - Global Heath/QoL
Month 3
|
8.8 Score on a Scale
Standard Deviation 20.31
|
|
Mean Change From Baseline on the EORTC QLQ-C30 - Global Heath/QoL
Month 6
|
12.5 Score on a Scale
Standard Deviation 19.12
|
|
Mean Change From Baseline on the EORTC QLQ-C30 - Global Heath/QoL
Month 9
|
15.7 Score on a Scale
Standard Deviation 20.88
|
|
Mean Change From Baseline on the EORTC QLQ-C30 - Global Heath/QoL
Month 12
|
14.1 Score on a Scale
Standard Deviation 21.57
|
|
Mean Change From Baseline on the EORTC QLQ-C30 - Global Heath/QoL
Month 18
|
10.6 Score on a Scale
Standard Deviation 17.25
|
|
Mean Change From Baseline on the EORTC QLQ-C30 - Global Heath/QoL
Month 24
|
7.1 Score on a Scale
Standard Deviation 14.93
|
SECONDARY outcome
Timeframe: At Day 1 and at specific time points up to month 24Population: PRO Analysis Set
Mean change from baseline on the EORTC QLQ-MY20 The EORTC has developed a myeloma module referred to as QLQ- MY20, to be administered alongside the core QLQ-C30. The QLQ-MY20 is a 20-item myeloma module intended for use among patients varying in disease stage and treatment modality. All items will be scored from 0 to 100. The average of the scores will represent the symptoms score. A high score for a symptom scale/item represents a high level of symptomatic problem.
Outcome measures
| Measure |
BB2121
n=126 Participants
BB2121
|
|---|---|
|
Mean Change From Baseline on the EORTC QLQ-MY20 - Disease Symptoms
Day 1
|
-0.8 Score on a Scale
Standard Deviation 14.11
|
|
Mean Change From Baseline on the EORTC QLQ-MY20 - Disease Symptoms
Month 1
|
-10.2 Score on a Scale
Standard Deviation 18.54
|
|
Mean Change From Baseline on the EORTC QLQ-MY20 - Disease Symptoms
Month 3
|
-10.8 Score on a Scale
Standard Deviation 20.32
|
|
Mean Change From Baseline on the EORTC QLQ-MY20 - Disease Symptoms
Month 6
|
-12.6 Score on a Scale
Standard Deviation 20.81
|
|
Mean Change From Baseline on the EORTC QLQ-MY20 - Disease Symptoms
Month 9
|
-14.4 Score on a Scale
Standard Deviation 20.29
|
|
Mean Change From Baseline on the EORTC QLQ-MY20 - Disease Symptoms
Month 12
|
-15.7 Score on a Scale
Standard Deviation 23.28
|
|
Mean Change From Baseline on the EORTC QLQ-MY20 - Disease Symptoms
Month 18
|
-12.0 Score on a Scale
Standard Deviation 20.47
|
|
Mean Change From Baseline on the EORTC QLQ-MY20 - Disease Symptoms
Month 24
|
-13.1 Score on a Scale
Standard Deviation 19.07
|
SECONDARY outcome
Timeframe: At Day 1 and at specific time points up to month 24Population: PRO Analysis Set
Mean change from baseline on the EORTC QLQ-MY20 The EORTC has developed a myeloma module referred to as QLQ- MY20, to be administered alongside the core QLQ-C30. The QLQ-MY20 is a 20-item myeloma module intended for use among patients varying in disease stage and treatment modality. All items will be scored from 0 to 100. The average of the scores will represent the symptoms score. A high score for a symptom scale/item represents a high level of symptomatic problem.
Outcome measures
| Measure |
BB2121
n=126 Participants
BB2121
|
|---|---|
|
Mean Change From Baseline on the EORTC QLQ-MY20 - Side Effects
Day 1
|
2.5 Score on a Scale
Standard Deviation 9.51
|
|
Mean Change From Baseline on the EORTC QLQ-MY20 - Side Effects
Month 1
|
0.0 Score on a Scale
Standard Deviation 11.95
|
|
Mean Change From Baseline on the EORTC QLQ-MY20 - Side Effects
Month 3
|
-2.6 Score on a Scale
Standard Deviation 11.45
|
|
Mean Change From Baseline on the EORTC QLQ-MY20 - Side Effects
Month 6
|
-4.7 Score on a Scale
Standard Deviation 10.16
|
|
Mean Change From Baseline on the EORTC QLQ-MY20 - Side Effects
Month 9
|
-6.5 Score on a Scale
Standard Deviation 10.28
|
|
Mean Change From Baseline on the EORTC QLQ-MY20 - Side Effects
Month 12
|
-4.0 Score on a Scale
Standard Deviation 11.87
|
|
Mean Change From Baseline on the EORTC QLQ-MY20 - Side Effects
Month 24
|
-3.2 Score on a Scale
Standard Deviation 7.98
|
|
Mean Change From Baseline on the EORTC QLQ-MY20 - Side Effects
Month 18
|
-3.4 Score on a Scale
Standard Deviation 9.96
|
SECONDARY outcome
Timeframe: At Day 1 and at specific time points up to month 24Population: PRO Analysis Set
The European Quality of Life 5D-5L Scale (EQ-5D-5L) assesses general health-related quality of life. Health is defined in 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. Responses are coded so that a '1' indicates no problem, and '5' indicates the most serious problem. The responses for the 5 dimensions are combined in a 5-digit number. The EQ-5D-5L health utility index (HUI) is assessed using the Crosswalk algorithm for France based on the individual responses to the 5 EQ-5D-5L domains ranging from -0.530 to 1.000. The smallest change considered clinically meaningful, is defined as a score difference of 0.08 points.
Outcome measures
| Measure |
BB2121
n=126 Participants
BB2121
|
|---|---|
|
Mean Change From Baseline on the EQ-5D-5L Index
Day 1
|
0.0314 Score on a Scale
Standard Deviation 0.1760
|
|
Mean Change From Baseline on the EQ-5D-5L Index
Month 1
|
0.0528 Score on a Scale
Standard Deviation 0.2473
|
|
Mean Change From Baseline on the EQ-5D-5L Index
Month 3
|
0.0998 Score on a Scale
Standard Deviation 0.1956
|
|
Mean Change From Baseline on the EQ-5D-5L Index
Month 6
|
0.0974 Score on a Scale
Standard Deviation 0.1798
|
|
Mean Change From Baseline on the EQ-5D-5L Index
Month 9
|
0.1067 Score on a Scale
Standard Deviation 0.2334
|
|
Mean Change From Baseline on the EQ-5D-5L Index
Month 12
|
0.1097 Score on a Scale
Standard Deviation 0.2287
|
|
Mean Change From Baseline on the EQ-5D-5L Index
Month 18
|
0.1101 Score on a Scale
Standard Deviation 0.2027
|
|
Mean Change From Baseline on the EQ-5D-5L Index
Month 24
|
0.0383 Score on a Scale
Standard Deviation 0.1604
|
Adverse Events
BB2121
Serious events: 108 serious events
Other events: 137 other events
Deaths: 82 deaths
Serious adverse events
| Measure |
BB2121
n=137 participants at risk
BB2121
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.5%
2/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.73%
1/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
8.8%
12/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Blood and lymphatic system disorders
Hyperviscosity syndrome
|
0.73%
1/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Blood and lymphatic system disorders
Neutropenia
|
4.4%
6/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.73%
1/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
6.6%
9/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Blood and lymphatic system disorders
Thrombotic microangiopathy
|
0.73%
1/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Cardiac disorders
Angina pectoris
|
0.73%
1/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Cardiac disorders
Atrial fibrillation
|
1.5%
2/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Cardiac disorders
Cardiac arrest
|
0.73%
1/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Cardiac disorders
Coronary artery disease
|
0.73%
1/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Cardiac disorders
Pericardial effusion
|
2.2%
3/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Cardiac disorders
Pericarditis
|
0.73%
1/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Cardiac disorders
Tachycardia
|
0.73%
1/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Eye disorders
Diplopia
|
0.73%
1/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Abdominal pain
|
0.73%
1/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.73%
1/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Diarrhoea
|
1.5%
2/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.5%
2/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Melaena
|
0.73%
1/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Nausea
|
0.73%
1/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Asthenia
|
1.5%
2/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Chills
|
0.73%
1/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Fatigue
|
0.73%
1/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
General physical health deterioration
|
21.9%
30/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Localised oedema
|
0.73%
1/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Mucosal inflammation
|
1.5%
2/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Pain
|
0.73%
1/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Pyrexia
|
5.8%
8/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Immune system disorders
Acute graft versus host disease
|
0.73%
1/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Immune system disorders
Cytokine release syndrome
|
16.1%
22/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Immune system disorders
Haemophagocytic lymphohistiocytosis
|
1.5%
2/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Acute sinusitis
|
0.73%
1/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Arthritis infective
|
0.73%
1/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Bacteraemia
|
1.5%
2/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Bronchitis
|
0.73%
1/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Bronchopulmonary aspergillosis
|
0.73%
1/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Clostridium difficile colitis
|
1.5%
2/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Coronavirus infection
|
0.73%
1/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Device related bacteraemia
|
0.73%
1/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Device related infection
|
0.73%
1/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Enterococcal bacteraemia
|
0.73%
1/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Erysipelas
|
0.73%
1/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Escherichia bacteraemia
|
0.73%
1/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Gastroenteritis salmonella
|
0.73%
1/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Haemophilus infection
|
0.73%
1/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Hepatitis E
|
1.5%
2/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Herpes zoster
|
0.73%
1/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Hypopyon
|
0.73%
1/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Infection
|
0.73%
1/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Influenza
|
3.6%
5/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Listeriosis
|
0.73%
1/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Lower respiratory tract infection viral
|
0.73%
1/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Pneumonia
|
10.9%
15/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Pneumonia aspiration
|
0.73%
1/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Pneumonia cytomegaloviral
|
0.73%
1/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Pneumonia pneumococcal
|
0.73%
1/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Pneumonia pseudomonal
|
2.2%
3/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Respiratory tract infection
|
2.2%
3/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Rhinovirus infection
|
1.5%
2/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Sepsis
|
5.1%
7/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Septic shock
|
1.5%
2/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Serratia bacteraemia
|
0.73%
1/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Typhoid fever
|
0.73%
1/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Upper respiratory tract infection
|
0.73%
1/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Urinary tract infection
|
0.73%
1/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Injury, poisoning and procedural complications
Compression fracture
|
0.73%
1/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.73%
1/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Injury, poisoning and procedural complications
Hyphaema
|
0.73%
1/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.73%
1/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Injury, poisoning and procedural complications
Stress fracture
|
0.73%
1/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.73%
1/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.73%
1/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.73%
1/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Alanine aminotransferase increased
|
0.73%
1/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Aspartate aminotransferase increased
|
0.73%
1/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Blood alkaline phosphatase increased
|
0.73%
1/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Blood bilirubin increased
|
0.73%
1/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Blood creatinine increased
|
0.73%
1/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
C-reactive protein increased
|
2.2%
3/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Coronavirus test positive
|
0.73%
1/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Acidosis
|
0.73%
1/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Adult failure to thrive
|
1.5%
2/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.73%
1/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.73%
1/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.73%
1/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
0.73%
1/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.5%
2/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.2%
3/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
2.2%
3/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.73%
1/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.73%
1/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.5%
2/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
1.5%
2/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.73%
1/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anal cancer
|
0.73%
1/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
3.6%
5/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.73%
1/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.73%
1/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell leukaemia
|
0.73%
1/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasmablastic lymphoma
|
0.73%
1/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
1.5%
2/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Amnesia
|
0.73%
1/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Aphasia
|
1.5%
2/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Ataxia
|
0.73%
1/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Cauda equina syndrome
|
0.73%
1/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Cerebral haematoma
|
1.5%
2/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Cerebral haemorrhage
|
1.5%
2/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Cognitive disorder
|
0.73%
1/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Dysarthria
|
0.73%
1/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Encephalopathy
|
2.9%
4/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Headache
|
1.5%
2/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Hemiparesis
|
0.73%
1/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Hypotonia
|
0.73%
1/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Lethargy
|
1.5%
2/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.73%
1/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Migraine
|
0.73%
1/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Paraesthesia
|
1.5%
2/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Seizure
|
1.5%
2/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Spinal cord compression
|
0.73%
1/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Syncope
|
1.5%
2/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Psychiatric disorders
Confusional state
|
2.9%
4/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Psychiatric disorders
Delirium
|
2.2%
3/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Psychiatric disorders
Disorientation
|
0.73%
1/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Psychiatric disorders
Hallucination
|
0.73%
1/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Psychiatric disorders
Mental status changes
|
2.2%
3/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Psychiatric disorders
Mood altered
|
0.73%
1/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Renal and urinary disorders
Acute kidney injury
|
3.6%
5/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.73%
1/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Renal and urinary disorders
Renal failure
|
0.73%
1/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.73%
1/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.73%
1/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.9%
4/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.5%
2/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.73%
1/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.73%
1/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.73%
1/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.73%
1/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.73%
1/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Upper airway obstruction
|
0.73%
1/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.73%
1/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.73%
1/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Vascular disorders
Deep vein thrombosis
|
0.73%
1/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Vascular disorders
Distributive shock
|
0.73%
1/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Vascular disorders
Hypotension
|
1.5%
2/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Vascular disorders
Pelvic venous thrombosis
|
0.73%
1/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
Other adverse events
| Measure |
BB2121
n=137 participants at risk
BB2121
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
75.9%
104/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
13.9%
19/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Blood and lymphatic system disorders
Leukopenia
|
51.1%
70/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Blood and lymphatic system disorders
Lymphopenia
|
35.8%
49/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Blood and lymphatic system disorders
Neutropenia
|
94.9%
130/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
69.3%
95/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Cardiac disorders
Tachycardia
|
16.1%
22/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Constipation
|
32.8%
45/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Diarrhoea
|
44.5%
61/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Dry mouth
|
7.3%
10/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Dyspepsia
|
8.8%
12/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Nausea
|
62.0%
85/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Vomiting
|
24.8%
34/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Asthenia
|
16.1%
22/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Chills
|
14.6%
20/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Fatigue
|
38.7%
53/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Malaise
|
5.1%
7/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Oedema peripheral
|
19.7%
27/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Pain
|
6.6%
9/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Pyrexia
|
26.3%
36/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Immune system disorders
Cytokine release syndrome
|
80.3%
110/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Immune system disorders
Hypogammaglobulinaemia
|
23.4%
32/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Candida infection
|
5.8%
8/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Influenza
|
6.6%
9/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Nasopharyngitis
|
7.3%
10/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Pneumonia
|
6.6%
9/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Respiratory tract infection
|
5.8%
8/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Sinusitis
|
5.1%
7/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Upper respiratory tract infection
|
15.3%
21/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Urinary tract infection
|
5.8%
8/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
6.6%
9/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Activated partial thromboplastin time prolonged
|
5.1%
7/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Alanine aminotransferase increased
|
16.1%
22/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Aspartate aminotransferase increased
|
19.0%
26/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Blood alkaline phosphatase increased
|
13.1%
18/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Blood creatinine increased
|
5.8%
8/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
C-reactive protein increased
|
10.9%
15/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
International normalised ratio increased
|
5.1%
7/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Weight decreased
|
13.9%
19/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Weight increased
|
5.8%
8/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Decreased appetite
|
29.9%
41/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
8.8%
12/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
10.9%
15/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
5.1%
7/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
9.5%
13/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
19.0%
26/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
27.0%
37/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
40.9%
56/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
25.5%
35/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
21.9%
30/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
33.6%
46/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
23.4%
32/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
21.2%
29/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
13.1%
18/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
6.6%
9/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
8.0%
11/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.8%
8/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.8%
12/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Dizziness
|
16.8%
23/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Headache
|
34.3%
47/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Somnolence
|
7.3%
10/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Tremor
|
8.8%
12/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Psychiatric disorders
Anxiety
|
13.9%
19/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Psychiatric disorders
Confusional state
|
11.7%
16/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Psychiatric disorders
Insomnia
|
10.2%
14/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Renal and urinary disorders
Acute kidney injury
|
8.0%
11/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Renal and urinary disorders
Pollakiuria
|
5.1%
7/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
24.8%
34/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
10.2%
14/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
5.8%
8/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
8.0%
11/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
8.0%
11/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
9.5%
13/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
5.8%
8/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
5.1%
7/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
8.0%
11/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.6%
9/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Skin and subcutaneous tissue disorders
Rash
|
8.8%
12/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Vascular disorders
Hypertension
|
13.9%
19/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Vascular disorders
Hypotension
|
17.5%
24/137 • From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
Additional Information
Bristol-Myers Squibb Study Director
Bristol-Myers Squibb
Phone: 1-855-907-3286
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
- Publication restrictions are in place
Restriction type: OTHER