Trial Outcomes & Findings for Study of Nivolumab Versus Placebo in Combination With Neoadjuvant Chemotherapy and Adjuvant Endocrine Therapy in Participants With High-risk, Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor 2-Negative (HER2-) Primary Breast Cancer (NCT NCT04109066)
NCT ID: NCT04109066
Last Updated: 2025-01-08
Results Overview
pCR rate is defined as the percentage of participants who achieved pCR. pCR is defined as no invasive residual disease in breast and lymph nodes performed by a local pathologist. Criteria for evaluation of pCR includes the following: pCR in breast, axillary lymph nodes and non-axillary sentinel node; no histologic evidence of invasive tumor cells; and pCR in the breast.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
521 participants
Primary outcome timeframe
Up to approximately 37 months
Results posted on
2025-01-08
Participant Flow
2 Participants planned for Arm B treatment received Arm A treatment.
Participant milestones
| Measure |
Arm A
Neoadjuvant (Pre-surgery) Phase 8 cycles maximum:
Paclitaxel (PTX) Cycles 1-4 (1 cycle = Q3W): Nivolumab 360 mg Q3W + PTX QW
Followed by:
Anthracycline-Cyclophosphamide (AC) Cycles 1-4 (1 cycle = Q2W or Q3W):
Nivolumab 360 mg Q3W + AC Q3W or Nivolumab 240 mg Q2W + AC Q2W
Surgery and Adjuvant (Post-surgery) Phase 7 cycles maximum:
Adjuvant Cycles 1-7 (1 cycle = Q4W):
Nivolumab 480 mg Q4W + Endocrine Therapy (ET)
|
Arm B
Neoadjuvant (Pre-surgery) Phase 8 cycles maximum:
Paclitaxel (PTX) Cycles 1-4 (1 cycle = Q3W): Nivolumab Placebo Q3W + PTX QW
Followed by:
Anthracycline-Cyclophosphamide (AC) Cycles 1-4 (1 cycle = Q2W or Q3W):
Nivolumab Placebo Q3W + AC Q3W or Nivolumab Placebo Q2W + AC Q2W
Surgery and Adjuvant (Post-surgery) Phase 7 cycles maximum:
Adjuvant Cycles 1-7 (1 cycle = Q4W):
Endocrine Therapy (ET)
|
|---|---|---|
|
Pre-treatment
STARTED
|
263
|
258
|
|
Pre-treatment
COMPLETED
|
260
|
257
|
|
Pre-treatment
NOT COMPLETED
|
3
|
1
|
|
Treatment
STARTED
|
260
|
257
|
|
Treatment
Received Arm A Treatment
|
0
|
2
|
|
Treatment
COMPLETED
|
167
|
174
|
|
Treatment
NOT COMPLETED
|
93
|
83
|
Reasons for withdrawal
| Measure |
Arm A
Neoadjuvant (Pre-surgery) Phase 8 cycles maximum:
Paclitaxel (PTX) Cycles 1-4 (1 cycle = Q3W): Nivolumab 360 mg Q3W + PTX QW
Followed by:
Anthracycline-Cyclophosphamide (AC) Cycles 1-4 (1 cycle = Q2W or Q3W):
Nivolumab 360 mg Q3W + AC Q3W or Nivolumab 240 mg Q2W + AC Q2W
Surgery and Adjuvant (Post-surgery) Phase 7 cycles maximum:
Adjuvant Cycles 1-7 (1 cycle = Q4W):
Nivolumab 480 mg Q4W + Endocrine Therapy (ET)
|
Arm B
Neoadjuvant (Pre-surgery) Phase 8 cycles maximum:
Paclitaxel (PTX) Cycles 1-4 (1 cycle = Q3W): Nivolumab Placebo Q3W + PTX QW
Followed by:
Anthracycline-Cyclophosphamide (AC) Cycles 1-4 (1 cycle = Q2W or Q3W):
Nivolumab Placebo Q3W + AC Q3W or Nivolumab Placebo Q2W + AC Q2W
Surgery and Adjuvant (Post-surgery) Phase 7 cycles maximum:
Adjuvant Cycles 1-7 (1 cycle = Q4W):
Endocrine Therapy (ET)
|
|---|---|---|
|
Pre-treatment
Participant withdrew consent
|
2
|
0
|
|
Pre-treatment
Participant no longer meets study criteria
|
1
|
1
|
|
Treatment
Lack of Efficacy
|
2
|
4
|
|
Treatment
Adverse Event
|
23
|
7
|
|
Treatment
Participant request to discontinue Study treatment
|
15
|
14
|
|
Treatment
Withdrawal by Subject
|
8
|
8
|
|
Treatment
Death
|
3
|
0
|
|
Treatment
Participant no longer meets study criteria
|
2
|
2
|
|
Treatment
Administrative reasons by sponsor
|
2
|
3
|
|
Treatment
Other reasons
|
17
|
23
|
|
Treatment
Disease Progression
|
4
|
7
|
|
Treatment
Study drug toxicity
|
12
|
5
|
|
Treatment
Adverse Event unrelated to Study drug
|
1
|
0
|
|
Treatment
Disease Recurrence
|
0
|
2
|
|
Treatment
Not reported
|
4
|
8
|
Baseline Characteristics
Study of Nivolumab Versus Placebo in Combination With Neoadjuvant Chemotherapy and Adjuvant Endocrine Therapy in Participants With High-risk, Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor 2-Negative (HER2-) Primary Breast Cancer
Baseline characteristics by cohort
| Measure |
Arm A
n=263 Participants
Neoadjuvant (Pre-surgery) Phase 8 cycles maximum:
Paclitaxel (PTX) Cycles 1-4 (1 cycle = Q3W): Nivolumab 360 mg Q3W + PTX QW
Followed by:
Anthracycline-Cyclophosphamide (AC) Cycles 1-4 (1 cycle = Q2W or Q3W):
Nivolumab 360 mg Q3W + AC Q3W or Nivolumab 240 mg Q2W + AC Q2W
Surgery and Adjuvant (Post-surgery) Phase 7 cycles maximum:
Adjuvant Cycles 1-7 (1 cycle = Q4W):
Nivolumab 480 mg Q4W + Endocrine Therapy (ET)
|
Arm B
n=258 Participants
Neoadjuvant (Pre-surgery) Phase 8 cycles maximum:
Paclitaxel (PTX) Cycles 1-4 (1 cycle = Q3W): Nivolumab Placebo Q3W + PTX QW
Followed by:
Anthracycline-Cyclophosphamide (AC) Cycles 1-4 (1 cycle = Q2W or Q3W):
Nivolumab Placebo Q3W + AC Q3W or Nivolumab Placebo Q2W + AC Q2W
Surgery and Adjuvant (Post-surgery) Phase 7 cycles maximum:
Adjuvant Cycles 1-7 (1 cycle = Q4W):
Endocrine Therapy (ET)
|
Total
n=521 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.9 Years
STANDARD_DEVIATION 12.0 • n=5 Participants
|
50.9 Years
STANDARD_DEVIATION 11.8 • n=7 Participants
|
50.4 Years
STANDARD_DEVIATION 11.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
262 Participants
n=5 Participants
|
257 Participants
n=7 Participants
|
519 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
74 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
154 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
102 Participants
n=5 Participants
|
121 Participants
n=7 Participants
|
223 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
87 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
144 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
18 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
24 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
202 Participants
n=5 Participants
|
193 Participants
n=7 Participants
|
395 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
11 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 37 monthsPopulation: All randomized participants with sufficient follow-up for pCR assessment
pCR rate is defined as the percentage of participants who achieved pCR. pCR is defined as no invasive residual disease in breast and lymph nodes performed by a local pathologist. Criteria for evaluation of pCR includes the following: pCR in breast, axillary lymph nodes and non-axillary sentinel node; no histologic evidence of invasive tumor cells; and pCR in the breast.
Outcome measures
| Measure |
Arm A
n=257 Participants
Neoadjuvant (Pre-surgery) Phase 8 cycles maximum:
Paclitaxel (PTX) Cycles 1-4 (1 cycle = Q3W): Nivolumab 360 mg Q3W + PTX QW
Followed by:
Anthracycline-Cyclophosphamide (AC) Cycles 1-4 (1 cycle = Q2W or Q3W):
Nivolumab 360 mg Q3W + AC Q3W or Nivolumab 240 mg Q2W + AC Q2W
Surgery and Adjuvant (Post-surgery) Phase 7 cycles maximum:
Adjuvant Cycles 1-7 (1 cycle = Q4W):
Nivolumab 480 mg Q4W + Endocrine Therapy (ET)
|
Arm B
n=253 Participants
Neoadjuvant (Pre-surgery) Phase 8 cycles maximum:
Paclitaxel (PTX) Cycles 1-4 (1 cycle = Q3W): Nivolumab Placebo Q3W + PTX QW
Followed by:
Anthracycline-Cyclophosphamide (AC) Cycles 1-4 (1 cycle = Q2W or Q3W):
Nivolumab Placebo Q3W + AC Q3W or Nivolumab Placebo Q2W + AC Q2W
Surgery and Adjuvant (Post-surgery) Phase 7 cycles maximum:
Adjuvant Cycles 1-7 (1 cycle = Q4W):
Endocrine Therapy (ET)
|
|---|---|---|
|
Pathological Complete Response (pCR) Rate
|
24.5 Percentage of participants
Interval 19.4 to 30.2
|
13.8 Percentage of participants
Interval 9.8 to 18.7
|
SECONDARY outcome
Timeframe: Up to approximately 37 monthsPopulation: All randomized participants in PD-L1 expression on immune cells \>=1% subgroup with sufficient follow-up for pCR assessment
pCR rate is defined as the percentage of participants who achieved pCR. pCR is defined as no invasive residual disease in breast and lymph nodes performed by a local pathologist. Criteria for evaluation of pCR includes the following: pCR in breast, axillary lymph nodes and non-axillary sentinel node; no histologic evidence of invasive tumor cells; and pCR in the breast.
Outcome measures
| Measure |
Arm A
n=88 Participants
Neoadjuvant (Pre-surgery) Phase 8 cycles maximum:
Paclitaxel (PTX) Cycles 1-4 (1 cycle = Q3W): Nivolumab 360 mg Q3W + PTX QW
Followed by:
Anthracycline-Cyclophosphamide (AC) Cycles 1-4 (1 cycle = Q2W or Q3W):
Nivolumab 360 mg Q3W + AC Q3W or Nivolumab 240 mg Q2W + AC Q2W
Surgery and Adjuvant (Post-surgery) Phase 7 cycles maximum:
Adjuvant Cycles 1-7 (1 cycle = Q4W):
Nivolumab 480 mg Q4W + Endocrine Therapy (ET)
|
Arm B
n=84 Participants
Neoadjuvant (Pre-surgery) Phase 8 cycles maximum:
Paclitaxel (PTX) Cycles 1-4 (1 cycle = Q3W): Nivolumab Placebo Q3W + PTX QW
Followed by:
Anthracycline-Cyclophosphamide (AC) Cycles 1-4 (1 cycle = Q2W or Q3W):
Nivolumab Placebo Q3W + AC Q3W or Nivolumab Placebo Q2W + AC Q2W
Surgery and Adjuvant (Post-surgery) Phase 7 cycles maximum:
Adjuvant Cycles 1-7 (1 cycle = Q4W):
Endocrine Therapy (ET)
|
|---|---|---|
|
Pathological Complete Response (pCR) Rate (PD-L1 >=1%)
|
44.3 Percentage of participants
Interval 33.7 to 55.3
|
20.2 Percentage of participants
Interval 12.3 to 30.4
|
SECONDARY outcome
Timeframe: Up to approximately 37 monthsPopulation: All randomized participants with sufficient follow-up for RCB assessment
RCB is estimated from routine pathologic sections of the primary breast tumor site and the regional lymph nodes after the completion of neoadjuvant therapy. RCB is categorized into the following 4 classes: RCB-0: no residual disease; RCB-1: minimal residual disease; RCB-II: moderate residual disease; RCB-III: and extensive residual disease.
Outcome measures
| Measure |
Arm A
n=257 Participants
Neoadjuvant (Pre-surgery) Phase 8 cycles maximum:
Paclitaxel (PTX) Cycles 1-4 (1 cycle = Q3W): Nivolumab 360 mg Q3W + PTX QW
Followed by:
Anthracycline-Cyclophosphamide (AC) Cycles 1-4 (1 cycle = Q2W or Q3W):
Nivolumab 360 mg Q3W + AC Q3W or Nivolumab 240 mg Q2W + AC Q2W
Surgery and Adjuvant (Post-surgery) Phase 7 cycles maximum:
Adjuvant Cycles 1-7 (1 cycle = Q4W):
Nivolumab 480 mg Q4W + Endocrine Therapy (ET)
|
Arm B
n=253 Participants
Neoadjuvant (Pre-surgery) Phase 8 cycles maximum:
Paclitaxel (PTX) Cycles 1-4 (1 cycle = Q3W): Nivolumab Placebo Q3W + PTX QW
Followed by:
Anthracycline-Cyclophosphamide (AC) Cycles 1-4 (1 cycle = Q2W or Q3W):
Nivolumab Placebo Q3W + AC Q3W or Nivolumab Placebo Q2W + AC Q2W
Surgery and Adjuvant (Post-surgery) Phase 7 cycles maximum:
Adjuvant Cycles 1-7 (1 cycle = Q4W):
Endocrine Therapy (ET)
|
|---|---|---|
|
Number of Participants With Residual Cancer Burden (RCB)
RCB-0
|
62 Participants
|
34 Participants
|
|
Number of Participants With Residual Cancer Burden (RCB)
RCB-I
|
17 Participants
|
20 Participants
|
|
Number of Participants With Residual Cancer Burden (RCB)
RCB-II
|
90 Participants
|
106 Participants
|
|
Number of Participants With Residual Cancer Burden (RCB)
RCB-III
|
57 Participants
|
73 Participants
|
|
Number of Participants With Residual Cancer Burden (RCB)
Not Reported
|
31 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: Up to approximately 37 monthsPopulation: All randomized participants in PD-L1 expression on immune cells \>=1% subgroup with sufficient follow-up for RCB assessment
RCB is estimated from routine pathologic sections of the primary breast tumor site and the regional lymph nodes after the completion of neoadjuvant therapy. RCB is categorized into the following 4 classes: RCB-0: no residual disease; RCB-1: minimal residual disease; RCB-II: moderate residual disease; RCB-III: and extensive residual disease.
Outcome measures
| Measure |
Arm A
n=88 Participants
Neoadjuvant (Pre-surgery) Phase 8 cycles maximum:
Paclitaxel (PTX) Cycles 1-4 (1 cycle = Q3W): Nivolumab 360 mg Q3W + PTX QW
Followed by:
Anthracycline-Cyclophosphamide (AC) Cycles 1-4 (1 cycle = Q2W or Q3W):
Nivolumab 360 mg Q3W + AC Q3W or Nivolumab 240 mg Q2W + AC Q2W
Surgery and Adjuvant (Post-surgery) Phase 7 cycles maximum:
Adjuvant Cycles 1-7 (1 cycle = Q4W):
Nivolumab 480 mg Q4W + Endocrine Therapy (ET)
|
Arm B
n=84 Participants
Neoadjuvant (Pre-surgery) Phase 8 cycles maximum:
Paclitaxel (PTX) Cycles 1-4 (1 cycle = Q3W): Nivolumab Placebo Q3W + PTX QW
Followed by:
Anthracycline-Cyclophosphamide (AC) Cycles 1-4 (1 cycle = Q2W or Q3W):
Nivolumab Placebo Q3W + AC Q3W or Nivolumab Placebo Q2W + AC Q2W
Surgery and Adjuvant (Post-surgery) Phase 7 cycles maximum:
Adjuvant Cycles 1-7 (1 cycle = Q4W):
Endocrine Therapy (ET)
|
|---|---|---|
|
Number of Participants With Residual Cancer Burden (RCB) PD-L1 >=1%
RCB-0
|
38 Participants
|
16 Participants
|
|
Number of Participants With Residual Cancer Burden (RCB) PD-L1 >=1%
RCB-I
|
10 Participants
|
6 Participants
|
|
Number of Participants With Residual Cancer Burden (RCB) PD-L1 >=1%
RCB-II
|
25 Participants
|
36 Participants
|
|
Number of Participants With Residual Cancer Burden (RCB) PD-L1 >=1%
RCB-III
|
9 Participants
|
20 Participants
|
|
Number of Participants With Residual Cancer Burden (RCB) PD-L1 >=1%
Not Reported
|
6 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: From first dose to 30 days post last dose of neoadjuvant or adjuvant study therapy (Up to approximately 19 months)Population: All treated participants
Number of participants with any grade adverse events (AEs). An AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment that does not necessarily have a causal relation with this treatment. Toxicities will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Outcome measures
| Measure |
Arm A
n=262 Participants
Neoadjuvant (Pre-surgery) Phase 8 cycles maximum:
Paclitaxel (PTX) Cycles 1-4 (1 cycle = Q3W): Nivolumab 360 mg Q3W + PTX QW
Followed by:
Anthracycline-Cyclophosphamide (AC) Cycles 1-4 (1 cycle = Q2W or Q3W):
Nivolumab 360 mg Q3W + AC Q3W or Nivolumab 240 mg Q2W + AC Q2W
Surgery and Adjuvant (Post-surgery) Phase 7 cycles maximum:
Adjuvant Cycles 1-7 (1 cycle = Q4W):
Nivolumab 480 mg Q4W + Endocrine Therapy (ET)
|
Arm B
n=255 Participants
Neoadjuvant (Pre-surgery) Phase 8 cycles maximum:
Paclitaxel (PTX) Cycles 1-4 (1 cycle = Q3W): Nivolumab Placebo Q3W + PTX QW
Followed by:
Anthracycline-Cyclophosphamide (AC) Cycles 1-4 (1 cycle = Q2W or Q3W):
Nivolumab Placebo Q3W + AC Q3W or Nivolumab Placebo Q2W + AC Q2W
Surgery and Adjuvant (Post-surgery) Phase 7 cycles maximum:
Adjuvant Cycles 1-7 (1 cycle = Q4W):
Endocrine Therapy (ET)
|
|---|---|---|
|
Number of Participants With Adverse Events (AEs)
Adverse Events (AEs)
|
259 Participants
|
252 Participants
|
|
Number of Participants With Adverse Events (AEs)
Drug-Related AEs
|
254 Participants
|
236 Participants
|
|
Number of Participants With Adverse Events (AEs)
AEs leading to discontinuation
|
41 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: From first dose to 30 days post last dose of neoadjuvant or adjuvant study therapy (Up to approximately 19 months)Population: All treated participants
Number of participants with any grade serious adverse events (SAE). SAE is defined as any untoward medical occurrence that, at any dose: Results in death; is life threatening; requires inpatient hospitalization; results in persistent or significant disability; is a congenital anomaly/birth defect. Toxicities will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Outcome measures
| Measure |
Arm A
n=262 Participants
Neoadjuvant (Pre-surgery) Phase 8 cycles maximum:
Paclitaxel (PTX) Cycles 1-4 (1 cycle = Q3W): Nivolumab 360 mg Q3W + PTX QW
Followed by:
Anthracycline-Cyclophosphamide (AC) Cycles 1-4 (1 cycle = Q2W or Q3W):
Nivolumab 360 mg Q3W + AC Q3W or Nivolumab 240 mg Q2W + AC Q2W
Surgery and Adjuvant (Post-surgery) Phase 7 cycles maximum:
Adjuvant Cycles 1-7 (1 cycle = Q4W):
Nivolumab 480 mg Q4W + Endocrine Therapy (ET)
|
Arm B
n=255 Participants
Neoadjuvant (Pre-surgery) Phase 8 cycles maximum:
Paclitaxel (PTX) Cycles 1-4 (1 cycle = Q3W): Nivolumab Placebo Q3W + PTX QW
Followed by:
Anthracycline-Cyclophosphamide (AC) Cycles 1-4 (1 cycle = Q2W or Q3W):
Nivolumab Placebo Q3W + AC Q3W or Nivolumab Placebo Q2W + AC Q2W
Surgery and Adjuvant (Post-surgery) Phase 7 cycles maximum:
Adjuvant Cycles 1-7 (1 cycle = Q4W):
Endocrine Therapy (ET)
|
|---|---|---|
|
Number of Participants With Serious Adverse Events (SAEs)
|
80 Participants
|
45 Participants
|
SECONDARY outcome
Timeframe: Up to approximately 41 monthsPopulation: All treated participants
Number of participants who died due to any cause.
Outcome measures
| Measure |
Arm A
n=262 Participants
Neoadjuvant (Pre-surgery) Phase 8 cycles maximum:
Paclitaxel (PTX) Cycles 1-4 (1 cycle = Q3W): Nivolumab 360 mg Q3W + PTX QW
Followed by:
Anthracycline-Cyclophosphamide (AC) Cycles 1-4 (1 cycle = Q2W or Q3W):
Nivolumab 360 mg Q3W + AC Q3W or Nivolumab 240 mg Q2W + AC Q2W
Surgery and Adjuvant (Post-surgery) Phase 7 cycles maximum:
Adjuvant Cycles 1-7 (1 cycle = Q4W):
Nivolumab 480 mg Q4W + Endocrine Therapy (ET)
|
Arm B
n=255 Participants
Neoadjuvant (Pre-surgery) Phase 8 cycles maximum:
Paclitaxel (PTX) Cycles 1-4 (1 cycle = Q3W): Nivolumab Placebo Q3W + PTX QW
Followed by:
Anthracycline-Cyclophosphamide (AC) Cycles 1-4 (1 cycle = Q2W or Q3W):
Nivolumab Placebo Q3W + AC Q3W or Nivolumab Placebo Q2W + AC Q2W
Surgery and Adjuvant (Post-surgery) Phase 7 cycles maximum:
Adjuvant Cycles 1-7 (1 cycle = Q4W):
Endocrine Therapy (ET)
|
|---|---|---|
|
Number of Participants Who Died
|
15 Participants
|
8 Participants
|
Adverse Events
Arm A: Nivo + Chemo (PTX QW + AC Q3W) / Nivo + ET
Serious events: 38 serious events
Other events: 126 other events
Deaths: 8 deaths
Arm A: Nivo + Chemo (PTX QW + AC Q2W) / Nivo + ET
Serious events: 51 serious events
Other events: 132 other events
Deaths: 7 deaths
Arm B: Nivo Placebo + Chemo (PTX QW + AC Q3W) / ET
Serious events: 20 serious events
Other events: 120 other events
Deaths: 4 deaths
Arm B: Nivo Placebo + Chemo (PTX QW + AC Q2W) / ET
Serious events: 26 serious events
Other events: 130 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Arm A: Nivo + Chemo (PTX QW + AC Q3W) / Nivo + ET
n=127 participants at risk
Neoadjuvant (Pre-surgery) Phase 8 cycles maximum:
Paclitaxel (PTX) Cycles 1-4 (1 cycle = Q3W): Nivolumab 360 mg Q3W + PTX QW
Followed by:
Anthracycline-Cyclophosphamide (AC) Cycles 1-4 (1 cycle = Q3W):
Nivolumab 360 mg Q3W + AC Q3W
Surgery and Adjuvant (Post-surgery) Phase 7 cycles maximum:
Adjuvant Cycles 1-7 (1 cycle = Q4W):
Nivolumab 480 mg Q4W + Endocrine Therapy (ET)
|
Arm A: Nivo + Chemo (PTX QW + AC Q2W) / Nivo + ET
n=135 participants at risk
Neoadjuvant (Pre-surgery) Phase 8 cycles maximum:
Paclitaxel (PTX) Cycles 1-4 (1 cycle = Q3W): Nivolumab 360 mg Q3W + PTX QW
Followed by:
Anthracycline-Cyclophosphamide (AC) Cycles 1-4 (1 cycle = Q2W):
Nivolumab 240 mg Q2W + AC Q2W
Surgery and Adjuvant (Post-surgery) Phase 7 cycles maximum:
Adjuvant Cycles 1-7 (1 cycle = Q4W):
Nivolumab 480 mg Q4W + Endocrine Therapy (ET)
|
Arm B: Nivo Placebo + Chemo (PTX QW + AC Q3W) / ET
n=123 participants at risk
Neoadjuvant (Pre-surgery) Phase 8 cycles maximum:
Paclitaxel (PTX) Cycles 1-4 (1 cycle = Q3W): Nivolumab Placebo Q3W + PTX QW
Followed by:
Anthracycline-Cyclophosphamide (AC) Cycles 1-4 (1 cycle = Q3W):
Nivolumab Placebo Q3W + AC Q3W
Surgery and Adjuvant (Post-surgery) Phase 7 cycles maximum:
Adjuvant Cycles 1-7 (1 cycle = Q4W):
Endocrine Therapy (ET)
|
Arm B: Nivo Placebo + Chemo (PTX QW + AC Q2W) / ET
n=132 participants at risk
Neoadjuvant (Pre-surgery) Phase 8 cycles maximum:
Paclitaxel (PTX) Cycles 1-4 (1 cycle = Q3W): Nivolumab Placebo Q3W + PTX QW
Followed by:
Anthracycline-Cyclophosphamide (AC) Cycles 1-4 (1 cycle = Q2W):
Nivolumab Placebo Q2W + AC Q2W
Surgery and Adjuvant (Post-surgery) Phase 7 cycles maximum:
Adjuvant Cycles 1-7 (1 cycle = Q4W):
Endocrine Therapy (ET)
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.6%
2/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
1.5%
2/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.4%
3/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
6.7%
9/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
3.0%
4/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.74%
1/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Blood and lymphatic system disorders
Myelosuppression
|
0.79%
1/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.6%
2/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
1.5%
2/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
1.6%
2/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.81%
1/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.76%
1/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Cardiac disorders
Cardiac failure
|
0.79%
1/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.74%
1/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.76%
1/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.81%
1/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Cardiac disorders
Cardiac perfusion defect
|
0.79%
1/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.79%
1/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Cardiac disorders
Left ventricular failure
|
0.79%
1/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Cardiac disorders
Myocardial infarction
|
0.79%
1/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Cardiac disorders
Myocarditis
|
0.79%
1/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.81%
1/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.74%
1/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.74%
1/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Ear and labyrinth disorders
Vertigo
|
0.79%
1/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.79%
1/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.74%
1/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Endocrine disorders
Hypopituitarism
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.74%
1/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Endocrine disorders
Immune-mediated adrenal insufficiency
|
0.79%
1/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Endocrine disorders
Thyroiditis subacute
|
0.79%
1/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.76%
1/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.79%
1/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Gastrointestinal disorders
Colitis
|
0.79%
1/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.81%
1/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
1.6%
2/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.74%
1/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.74%
1/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.76%
1/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.76%
1/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Gastrointestinal disorders
Vomiting
|
0.79%
1/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.81%
1/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.76%
1/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
General disorders
Death
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.74%
1/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
General disorders
Disease progression
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.76%
1/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
General disorders
Malaise
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.74%
1/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.76%
1/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
General disorders
Pyrexia
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
3.0%
4/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Hepatobiliary disorders
Autoimmune hepatitis
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.74%
1/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.74%
1/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.74%
1/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.74%
1/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Hepatobiliary disorders
Hepatitis cholestatic
|
0.79%
1/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Immune system disorders
Anaphylactic reaction
|
0.79%
1/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Immune system disorders
Anaphylactic shock
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.74%
1/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Infections and infestations
Breast abscess
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.81%
1/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Infections and infestations
Breast cellulitis
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
1.5%
2/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.81%
1/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Infections and infestations
COVID-19
|
1.6%
2/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
3.7%
5/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
1.6%
2/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.76%
1/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Infections and infestations
COVID-19 pneumonia
|
2.4%
3/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.74%
1/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Infections and infestations
Catheter site infection
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.74%
1/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.81%
1/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Infections and infestations
Cystitis
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.74%
1/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Infections and infestations
Device related infection
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.74%
1/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.81%
1/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.76%
1/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Infections and infestations
Infection
|
0.79%
1/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.76%
1/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Infections and infestations
Mastitis
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.81%
1/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.76%
1/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Infections and infestations
Neutropenic infection
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.74%
1/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.81%
1/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Infections and infestations
Neutropenic sepsis
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.74%
1/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Infections and infestations
Perirectal abscess
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.74%
1/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Infections and infestations
Pneumocystis jirovecii infection
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.76%
1/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.74%
1/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Infections and infestations
Pneumonia
|
0.79%
1/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
2.2%
3/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.81%
1/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
2.3%
3/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Infections and infestations
Pneumonia bacterial
|
0.79%
1/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Infections and infestations
Postoperative wound infection
|
1.6%
2/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.74%
1/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.74%
1/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Infections and infestations
SARS-CoV-2 sepsis
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.76%
1/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Infections and infestations
Sepsis
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.74%
1/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.76%
1/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Infections and infestations
Septic shock
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.74%
1/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Infections and infestations
Skin infection
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.74%
1/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.76%
1/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Infections and infestations
Systemic infection
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.74%
1/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.74%
1/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Infections and infestations
Urinary tract infection
|
0.79%
1/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.81%
1/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Infections and infestations
Vascular access site infection
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.76%
1/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Infections and infestations
Vascular device infection
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.76%
1/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Infections and infestations
Wound infection
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.74%
1/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.81%
1/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.81%
1/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Injury, poisoning and procedural complications
Craniofacial fracture
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.74%
1/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.74%
1/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.81%
1/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Injury, poisoning and procedural complications
Radiation skin injury
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
1.5%
2/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Injury, poisoning and procedural complications
Surgical procedure repeated
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
1.5%
2/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.74%
1/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.74%
1/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Investigations
Inflammatory marker increased
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.76%
1/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Investigations
Liver function test increased
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.76%
1/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Investigations
Neutrophil count decreased
|
0.79%
1/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
1.5%
2/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Investigations
White blood cell count decreased
|
0.79%
1/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.76%
1/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.79%
1/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.74%
1/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
1.5%
2/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Metabolism and nutrition disorders
Hypophagia
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.74%
1/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.76%
1/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.74%
1/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma
|
0.79%
1/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
1.6%
2/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.76%
1/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.81%
1/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.76%
1/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Nervous system disorders
Cerebellar syndrome
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.76%
1/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.81%
1/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Nervous system disorders
Guillain-Barre syndrome
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.74%
1/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Nervous system disorders
Headache
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.74%
1/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Nervous system disorders
Intracranial pressure increased
|
0.79%
1/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Nervous system disorders
Syncope
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.74%
1/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.81%
1/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Product Issues
Device occlusion
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.76%
1/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.76%
1/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.74%
1/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.81%
1/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Renal and urinary disorders
Glomerulonephritis
|
0.79%
1/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.74%
1/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Reproductive system and breast disorders
Breast inflammation
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.74%
1/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.79%
1/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Respiratory, thoracic and mediastinal disorders
Immune-mediated lung disease
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
1.5%
2/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.79%
1/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
1.5%
2/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.6%
2/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
1.5%
2/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Skin and subcutaneous tissue disorders
Pemphigoid
|
0.79%
1/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.76%
1/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.79%
1/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.74%
1/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.74%
1/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Vascular disorders
Arterial thrombosis
|
0.79%
1/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.74%
1/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.81%
1/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Vascular disorders
Embolism
|
0.79%
1/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Vascular disorders
Hypotension
|
0.79%
1/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.76%
1/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
Other adverse events
| Measure |
Arm A: Nivo + Chemo (PTX QW + AC Q3W) / Nivo + ET
n=127 participants at risk
Neoadjuvant (Pre-surgery) Phase 8 cycles maximum:
Paclitaxel (PTX) Cycles 1-4 (1 cycle = Q3W): Nivolumab 360 mg Q3W + PTX QW
Followed by:
Anthracycline-Cyclophosphamide (AC) Cycles 1-4 (1 cycle = Q3W):
Nivolumab 360 mg Q3W + AC Q3W
Surgery and Adjuvant (Post-surgery) Phase 7 cycles maximum:
Adjuvant Cycles 1-7 (1 cycle = Q4W):
Nivolumab 480 mg Q4W + Endocrine Therapy (ET)
|
Arm A: Nivo + Chemo (PTX QW + AC Q2W) / Nivo + ET
n=135 participants at risk
Neoadjuvant (Pre-surgery) Phase 8 cycles maximum:
Paclitaxel (PTX) Cycles 1-4 (1 cycle = Q3W): Nivolumab 360 mg Q3W + PTX QW
Followed by:
Anthracycline-Cyclophosphamide (AC) Cycles 1-4 (1 cycle = Q2W):
Nivolumab 240 mg Q2W + AC Q2W
Surgery and Adjuvant (Post-surgery) Phase 7 cycles maximum:
Adjuvant Cycles 1-7 (1 cycle = Q4W):
Nivolumab 480 mg Q4W + Endocrine Therapy (ET)
|
Arm B: Nivo Placebo + Chemo (PTX QW + AC Q3W) / ET
n=123 participants at risk
Neoadjuvant (Pre-surgery) Phase 8 cycles maximum:
Paclitaxel (PTX) Cycles 1-4 (1 cycle = Q3W): Nivolumab Placebo Q3W + PTX QW
Followed by:
Anthracycline-Cyclophosphamide (AC) Cycles 1-4 (1 cycle = Q3W):
Nivolumab Placebo Q3W + AC Q3W
Surgery and Adjuvant (Post-surgery) Phase 7 cycles maximum:
Adjuvant Cycles 1-7 (1 cycle = Q4W):
Endocrine Therapy (ET)
|
Arm B: Nivo Placebo + Chemo (PTX QW + AC Q2W) / ET
n=132 participants at risk
Neoadjuvant (Pre-surgery) Phase 8 cycles maximum:
Paclitaxel (PTX) Cycles 1-4 (1 cycle = Q3W): Nivolumab Placebo Q3W + PTX QW
Followed by:
Anthracycline-Cyclophosphamide (AC) Cycles 1-4 (1 cycle = Q2W):
Nivolumab Placebo Q2W + AC Q2W
Surgery and Adjuvant (Post-surgery) Phase 7 cycles maximum:
Adjuvant Cycles 1-7 (1 cycle = Q4W):
Endocrine Therapy (ET)
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
37.0%
47/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
48.1%
65/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
26.0%
32/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
47.0%
62/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Blood and lymphatic system disorders
Leukopenia
|
6.3%
8/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
5.9%
8/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
9.8%
12/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
8.3%
11/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
11.8%
15/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
6.7%
9/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
6.5%
8/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
9.1%
12/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Blood and lymphatic system disorders
Neutropenia
|
18.9%
24/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
19.3%
26/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
22.0%
27/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
18.2%
24/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.6%
2/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
5.2%
7/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.81%
1/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
2.3%
3/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Cardiac disorders
Palpitations
|
1.6%
2/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
4.4%
6/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.81%
1/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
5.3%
7/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Cardiac disorders
Tachycardia
|
2.4%
3/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
5.9%
8/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
3.0%
4/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Endocrine disorders
Adrenal insufficiency
|
3.9%
5/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
7.4%
10/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.76%
1/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Endocrine disorders
Hyperthyroidism
|
5.5%
7/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
9.6%
13/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
1.6%
2/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
3.8%
5/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Endocrine disorders
Hypothyroidism
|
15.0%
19/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
22.2%
30/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
6.5%
8/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
3.8%
5/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Eye disorders
Dry eye
|
3.1%
4/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
7.4%
10/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
3.3%
4/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
8.3%
11/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Eye disorders
Lacrimation increased
|
3.1%
4/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
5.2%
7/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
4.1%
5/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
3.8%
5/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Gastrointestinal disorders
Abdominal pain
|
4.7%
6/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
11.1%
15/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
7.3%
9/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
9.1%
12/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.5%
7/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
8.9%
12/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
3.3%
4/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
6.8%
9/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Gastrointestinal disorders
Constipation
|
18.1%
23/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
26.7%
36/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
15.4%
19/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
22.7%
30/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Gastrointestinal disorders
Diarrhoea
|
23.6%
30/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
35.6%
48/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
21.1%
26/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
30.3%
40/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Gastrointestinal disorders
Dry mouth
|
3.9%
5/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
6.7%
9/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
3.3%
4/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
5.3%
7/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Gastrointestinal disorders
Dyspepsia
|
7.1%
9/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
7.4%
10/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
4.1%
5/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
3.8%
5/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
3.1%
4/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
6.7%
9/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
1.6%
2/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
10.6%
14/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Gastrointestinal disorders
Nausea
|
48.0%
61/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
57.0%
77/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
44.7%
55/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
44.7%
59/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Gastrointestinal disorders
Stomatitis
|
3.1%
4/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
10.4%
14/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
3.3%
4/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
9.1%
12/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Gastrointestinal disorders
Vomiting
|
20.5%
26/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
20.0%
27/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
20.3%
25/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
9.8%
13/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
General disorders
Asthenia
|
21.3%
27/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
18.5%
25/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
24.4%
30/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
20.5%
27/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
General disorders
Chills
|
0.79%
1/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
5.9%
8/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.81%
1/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
1.5%
2/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
General disorders
Fatigue
|
26.8%
34/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
49.6%
67/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
19.5%
24/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
39.4%
52/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
General disorders
Illness
|
5.5%
7/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
1.6%
2/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.76%
1/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
General disorders
Mucosal inflammation
|
5.5%
7/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
11.9%
16/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
4.9%
6/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
14.4%
19/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
General disorders
Oedema peripheral
|
3.9%
5/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
8.9%
12/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
4.9%
6/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
9.8%
13/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
General disorders
Pain
|
3.9%
5/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
8.1%
11/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
1.6%
2/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
2.3%
3/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
General disorders
Pyrexia
|
8.7%
11/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
15.6%
21/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
5.7%
7/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
7.6%
10/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Immune system disorders
Hypersensitivity
|
6.3%
8/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
2.2%
3/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
4.1%
5/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
6.1%
8/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Infections and infestations
COVID-19
|
16.5%
21/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
21.5%
29/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
14.6%
18/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
22.0%
29/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Infections and infestations
Folliculitis
|
4.7%
6/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
6.7%
9/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.81%
1/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
3.8%
5/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Infections and infestations
Nasopharyngitis
|
3.1%
4/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
4.4%
6/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.81%
1/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
5.3%
7/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.79%
1/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
5.2%
7/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
6.5%
8/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
3.8%
5/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Infections and infestations
Urinary tract infection
|
9.4%
12/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
5.9%
8/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
7.3%
9/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
8.3%
11/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
9.4%
12/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
18.5%
25/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
8.1%
10/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
9.1%
12/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
2.4%
3/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
6.7%
9/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
4.1%
5/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
3.8%
5/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Injury, poisoning and procedural complications
Radiation skin injury
|
11.8%
15/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
16.3%
22/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
10.6%
13/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
15.2%
20/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Investigations
Alanine aminotransferase increased
|
21.3%
27/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
23.0%
31/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
18.7%
23/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
15.2%
20/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Investigations
Aspartate aminotransferase increased
|
25.2%
32/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
22.2%
30/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
18.7%
23/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
14.4%
19/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Investigations
Blood alkaline phosphatase increased
|
7.9%
10/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
6.7%
9/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
3.3%
4/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
3.8%
5/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Investigations
Blood calcium increased
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
5.2%
7/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
2.3%
3/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Investigations
Blood glucose increased
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
5.2%
7/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
1.5%
2/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Investigations
Blood lactate dehydrogenase increased
|
4.7%
6/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
4.4%
6/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
4.1%
5/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
6.8%
9/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Investigations
Blood sodium decreased
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
5.9%
8/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
3.8%
5/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Investigations
Blood thyroid stimulating hormone decreased
|
3.1%
4/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
8.1%
11/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
2.3%
3/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
3.9%
5/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
11.1%
15/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
2.4%
3/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
3.0%
4/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Investigations
Lymphocyte count decreased
|
3.1%
4/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
6.7%
9/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
1.6%
2/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
2.3%
3/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Investigations
Neutrophil count decreased
|
15.7%
20/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
11.9%
16/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
8.9%
11/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
8.3%
11/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Investigations
Weight decreased
|
5.5%
7/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
7.4%
10/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
2.4%
3/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
2.3%
3/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Investigations
White blood cell count decreased
|
11.8%
15/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
6.7%
9/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
6.5%
8/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
3.8%
5/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
12.6%
16/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
14.1%
19/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
10.6%
13/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
7.6%
10/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
11.8%
15/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
9.6%
13/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
6.5%
8/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
3.0%
4/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
3.1%
4/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
8.9%
12/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
4.5%
6/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
3.1%
4/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
2.2%
3/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
1.6%
2/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
5.3%
7/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.5%
21/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
30.4%
41/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
16.3%
20/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
31.8%
42/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.3%
8/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
11.9%
16/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
4.1%
5/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
12.9%
17/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
2.4%
3/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
8.9%
12/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
3.3%
4/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
7.6%
10/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
11.0%
14/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
19.3%
26/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
10.6%
13/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
16.7%
22/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.5%
7/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
10.4%
14/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
6.5%
8/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
9.1%
12/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Nervous system disorders
Dizziness
|
7.1%
9/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
7.4%
10/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
5.7%
7/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
6.1%
8/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Nervous system disorders
Dysgeusia
|
7.1%
9/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
19.3%
26/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
6.5%
8/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
10.6%
14/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Nervous system disorders
Headache
|
18.9%
24/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
31.9%
43/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
19.5%
24/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
25.0%
33/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Nervous system disorders
Neuropathy peripheral
|
20.5%
26/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
28.1%
38/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
15.4%
19/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
24.2%
32/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Nervous system disorders
Paraesthesia
|
6.3%
8/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
7.4%
10/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
6.5%
8/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
9.8%
13/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
6.3%
8/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
15.6%
21/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
8.1%
10/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
12.1%
16/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Nervous system disorders
Taste disorder
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
2.2%
3/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.81%
1/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
6.8%
9/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Psychiatric disorders
Anxiety
|
4.7%
6/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
7.4%
10/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
1.6%
2/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
4.5%
6/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Psychiatric disorders
Depression
|
2.4%
3/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
5.2%
7/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
6.1%
8/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Psychiatric disorders
Insomnia
|
6.3%
8/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
18.5%
25/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
6.5%
8/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
15.2%
20/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Reproductive system and breast disorders
Breast pain
|
3.1%
4/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
9.6%
13/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
4.9%
6/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
10.6%
14/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.2%
13/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
21.5%
29/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
7.3%
9/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
12.1%
16/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.1%
4/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
6.7%
9/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
7.3%
9/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
7.6%
10/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
8.7%
11/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
6.7%
9/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
6.5%
8/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
9.1%
12/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.4%
3/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
5.2%
7/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
3.3%
4/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
4.5%
6/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
2.4%
3/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
5.2%
7/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
3.3%
4/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.00%
0/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
65.4%
83/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
47.4%
64/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
65.0%
80/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
52.3%
69/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
2.4%
3/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
5.2%
7/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
2.4%
3/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
6.1%
8/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
2.4%
3/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
7.4%
10/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
8.1%
10/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
6.8%
9/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Skin and subcutaneous tissue disorders
Onycholysis
|
2.4%
3/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
3.7%
5/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.81%
1/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
6.1%
8/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
9.4%
12/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
16.3%
22/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
4.1%
5/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
13.6%
18/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Skin and subcutaneous tissue disorders
Rash
|
14.2%
18/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
22.2%
30/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
13.0%
16/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
21.2%
28/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
2.4%
3/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
3.7%
5/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
0.81%
1/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
6.1%
8/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Vascular disorders
Flushing
|
0.00%
0/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
5.2%
7/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
2.4%
3/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
5.3%
7/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Vascular disorders
Hot flush
|
7.1%
9/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
24.4%
33/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
9.8%
12/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
22.7%
30/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Vascular disorders
Hypertension
|
8.7%
11/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
6.7%
9/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
4.1%
5/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
5.3%
7/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
|
Vascular disorders
Lymphoedema
|
1.6%
2/127 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
3.7%
5/135 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
1.6%
2/123 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
5.3%
7/132 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. 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. The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
|
Additional Information
Bristol-Myers Squibb Study Director
Bristol-Myers Squibb
Phone: Please Email
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