Trial Outcomes & Findings for Lenvatinib in Combination With Pembrolizumab Versus Treatment of Physician's Choice in Participants With Advanced Endometrial Cancer (MK-3475-775/E7080-G000-309 Per Merck Standard Convention [KEYNOTE-775]) (NCT NCT03517449)
NCT ID: NCT03517449
Last Updated: 2026-03-19
Results Overview
PFS was defined as the time from the date of randomization to the date of the first documentation of disease progression, as determined by Blinded Independent Central Review (BICR) per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 or death due to any cause (whichever occurred first). Disease progression was defined as at least 20 percent (%) increase (including an absolute increase of at least 5 millimeter \[mm\]) in the sum of diameter of target lesions, taking as reference the smallest sum and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions. PFS was estimated and analyzed using Kaplan-Meier method.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
827 participants
Primary outcome timeframe
Up to approximately 27 months
Results posted on
2026-03-19
Participant Flow
Participants took part in the study at 167 investigative sites in Argentina, Australia, Brazil, Canada, Colombia, France, Germany, Ireland, Israel, Italy, Japan, Korea, Mexico, New Zealand, Poland, Russia, Spain, Taiwan, Turkey, United Kingdom and the United States
A total of 1178 participants were screened, of which 351 were screen failures and 827 (697 mismatch repair proficient \[pMMR\] participants and 130 MMR deficient \[dMMR\] participants) were enrolled and randomized, out of which 794 participants were treated.
Participant milestones
| Measure |
Lenvatinib 20 mg + Pembrolizumab 200 mg
Participants with EC received lenvatinib 20 mg orally, once daily, plus pembrolizumab 200 mg intravenously, every 3 weeks in each 21-day cycle. Participants continued to receive treatment until disease progression, development of unacceptable toxicity, withdrawal of consent, completion of 35 treatments (approximately 2 years) with pembrolizumab, or sponsor termination of the study.
|
Treatment of Physician's Choice (TPC): Doxorubicin or Paclitaxel
Participants with EC received either doxorubicin 60 milligrams per square meter (mg/m\^2) intravenously, every 3 weeks, in each 21-day treatment cycle, or paclitaxel 80 mg/m\^2 intravenously, weekly (3 weeks on/1 week off), in each 28-day treatment cycle. Participants continued to receive treatment until a lifetime cumulative dose of 500 mg/m\^2 doxorubicin, a maximum dose of paclitaxel per standard of care, or until disease progression, development of unacceptable toxicity, withdrawal of consent, or sponsor termination of the study.
|
|---|---|---|
|
Overall Study
STARTED
|
411
|
416
|
|
Overall Study
COMPLETED
|
411
|
416
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Lenvatinib in Combination With Pembrolizumab Versus Treatment of Physician's Choice in Participants With Advanced Endometrial Cancer (MK-3475-775/E7080-G000-309 Per Merck Standard Convention [KEYNOTE-775])
Baseline characteristics by cohort
| Measure |
Lenvatinib 20 mg + Pembrolizumab 200 mg
n=411 Participants
Participants with EC received lenvatinib 20 mg orally, once daily, plus pembrolizumab 200 mg intravenously, every 3 weeks in each 21-day cycle. Participants continued to receive treatment until disease progression, development of unacceptable toxicity, withdrawal of consent, completion of 35 treatments (approximately 2 years) with pembrolizumab, or sponsor termination of the study.
|
Treatment of Physician's Choice (TPC): Doxorubicin or Paclitaxel
n=416 Participants
Participants with EC received either doxorubicin 60 milligrams per square meter (mg/m\^2) intravenously, every 3 weeks, in each 21-day treatment cycle, or paclitaxel 80 mg/m\^2 intravenously, weekly (3 weeks on/1 week off), in each 28-day treatment cycle. Participants continued to receive treatment until a lifetime cumulative dose of 500 mg/m\^2 doxorubicin, a maximum dose of paclitaxel per standard of care, or until disease progression, development of unacceptable toxicity, withdrawal of consent, or sponsor termination of the study.
|
Total
n=827 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.2 years
STANDARD_DEVIATION 9.1 • n=110 Participants
|
63.8 years
STANDARD_DEVIATION 9.2 • n=114 Participants
|
63.5 years
STANDARD_DEVIATION 9.1 • n=224 Participants
|
|
Age, Customized
In utero
|
0 Participants
n=110 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=224 Participants
|
|
Age, Customized
Preterm newborn infants (gestational age < 37 wks)
|
0 Participants
n=110 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=224 Participants
|
|
Age, Customized
Newborns (0-27 days)
|
0 Participants
n=110 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=224 Participants
|
|
Age, Customized
Infants and toddlers (28 days-23 months)
|
0 Participants
n=110 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=224 Participants
|
|
Age, Customized
Children (2-11 years)
|
0 Participants
n=110 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=224 Participants
|
|
Age, Customized
Adolescents (12-17 years)
|
0 Participants
n=110 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=224 Participants
|
|
Age, Customized
Adults (18-64 years)
|
206 Participants
n=110 Participants
|
204 Participants
n=114 Participants
|
410 Participants
n=224 Participants
|
|
Age, Customized
From 65-84 years
|
205 Participants
n=110 Participants
|
210 Participants
n=114 Participants
|
415 Participants
n=224 Participants
|
|
Age, Customized
85 years and over
|
0 Participants
n=110 Participants
|
2 Participants
n=114 Participants
|
2 Participants
n=224 Participants
|
|
Sex: Female, Male
Female
|
411 Participants
n=110 Participants
|
416 Participants
n=114 Participants
|
827 Participants
n=224 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=110 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=224 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
59 Participants
n=110 Participants
|
73 Participants
n=114 Participants
|
132 Participants
n=224 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
309 Participants
n=110 Participants
|
288 Participants
n=114 Participants
|
597 Participants
n=224 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
43 Participants
n=110 Participants
|
55 Participants
n=114 Participants
|
98 Participants
n=224 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
4 Participants
n=110 Participants
|
7 Participants
n=114 Participants
|
11 Participants
n=224 Participants
|
|
Race (NIH/OMB)
Asian
|
85 Participants
n=110 Participants
|
92 Participants
n=114 Participants
|
177 Participants
n=224 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=110 Participants
|
0 Participants
n=114 Participants
|
1 Participants
n=224 Participants
|
|
Race (NIH/OMB)
Black or African American
|
17 Participants
n=110 Participants
|
14 Participants
n=114 Participants
|
31 Participants
n=224 Participants
|
|
Race (NIH/OMB)
White
|
261 Participants
n=110 Participants
|
247 Participants
n=114 Participants
|
508 Participants
n=224 Participants
|
|
Race (NIH/OMB)
More than one race
|
7 Participants
n=110 Participants
|
13 Participants
n=114 Participants
|
20 Participants
n=224 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
36 Participants
n=110 Participants
|
43 Participants
n=114 Participants
|
79 Participants
n=224 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) performance status
0 = Fully active; no performance restrictions
|
246 Participants
n=110 Participants
|
241 Participants
n=114 Participants
|
487 Participants
n=224 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) performance status
1 = Limited activity, ambulant, can-do light work
|
165 Participants
n=110 Participants
|
175 Participants
n=114 Participants
|
340 Participants
n=224 Participants
|
|
Prior history of pelvic radiation
Participants with pelvic radiation
|
176 Participants
n=110 Participants
|
187 Participants
n=114 Participants
|
363 Participants
n=224 Participants
|
|
Prior history of pelvic radiation
Participants without pelvic radiation
|
235 Participants
n=110 Participants
|
229 Participants
n=114 Participants
|
464 Participants
n=224 Participants
|
|
Geographic region
Region 1
|
234 Participants
n=110 Participants
|
240 Participants
n=114 Participants
|
474 Participants
n=224 Participants
|
|
Geographic region
Region 2
|
177 Participants
n=110 Participants
|
176 Participants
n=114 Participants
|
353 Participants
n=224 Participants
|
|
Mismatch repair (MMR) status
Proficient MMR (pMMR)
|
346 Participants
n=110 Participants
|
351 Participants
n=114 Participants
|
697 Participants
n=224 Participants
|
|
Mismatch repair (MMR) status
Deficient (dMMR)
|
65 Participants
n=110 Participants
|
65 Participants
n=114 Participants
|
130 Participants
n=224 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 27 monthsPopulation: Analysis population consisted of ITT (intent to treat) population which included all randomized participants. Data is reported for pMMR participants.
PFS was defined as the time from the date of randomization to the date of the first documentation of disease progression, as determined by Blinded Independent Central Review (BICR) per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 or death due to any cause (whichever occurred first). Disease progression was defined as at least 20 percent (%) increase (including an absolute increase of at least 5 millimeter \[mm\]) in the sum of diameter of target lesions, taking as reference the smallest sum and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions. PFS was estimated and analyzed using Kaplan-Meier method.
Outcome measures
| Measure |
Lenvatinib 20 mg + Pembrolizumab 200 mg
n=346 Participants
Participants with Endometrial cancer (EC) received lenvatinib 20 milligrams (mg) orally, once daily, plus pembrolizumab 200 mg intravenously, every 3 weeks in each 21-day cycle. Participants continued to receive treatment until disease progression, development of unacceptable toxicity, withdrawal of consent, completion of 35 treatments (approximately 2 years) with pembrolizumab, or sponsor termination of the study
|
Treatment of Physician's Choice (TPC): Doxorubicin or Paclitaxel
n=351 Participants
Participants with EC received either doxorubicin 60 milligrams per square meter (mg/m\^2) intravenously, every 3 weeks, in each 21-day treatment cycle, or paclitaxel 80 mg/m\^2 intravenously, weekly (3 weeks on/1 week off), in each 28-day treatment cycle. Participants continued to receive treatment until a lifetime cumulative dose of 500 mg/m\^2 doxorubicin, a maximum dose of paclitaxel per standard of care, or until disease progression, development of unacceptable toxicity, withdrawal of consent, or sponsor termination of the study.
|
|---|---|---|
|
Progression Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Based on Blinded Independent Central Review (BICR) in Mismatch Repair Proficient (pMMR) Participants
|
6.6 Months
95% Confidence Interval 5.6 • Interval 5.6 to 7.4
|
3.8 Months
95% Confidence Interval 3.6 • Interval 3.6 to 5.0
|
PRIMARY outcome
Timeframe: Up to approximately 27 monthsPopulation: Analysis population consisted of ITT population which included all randomized participants.
PFS was defined as the time from the date of randomization to the date of the first documentation of disease progression, as determined by Blinded Independent Central Review (BICR) per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 or death due to any cause (whichever occurred first). Disease progression was defined as at least 20 percent (%) increase (including an absolute increase of at least 5 millimeter \[mm\]) in the sum of diameter of target lesions, taking as reference the smallest sum and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions. PFS was estimated and analyzed using Kaplan-Meier method.
Outcome measures
| Measure |
Lenvatinib 20 mg + Pembrolizumab 200 mg
n=411 Participants
Participants with Endometrial cancer (EC) received lenvatinib 20 milligrams (mg) orally, once daily, plus pembrolizumab 200 mg intravenously, every 3 weeks in each 21-day cycle. Participants continued to receive treatment until disease progression, development of unacceptable toxicity, withdrawal of consent, completion of 35 treatments (approximately 2 years) with pembrolizumab, or sponsor termination of the study
|
Treatment of Physician's Choice (TPC): Doxorubicin or Paclitaxel
n=416 Participants
Participants with EC received either doxorubicin 60 milligrams per square meter (mg/m\^2) intravenously, every 3 weeks, in each 21-day treatment cycle, or paclitaxel 80 mg/m\^2 intravenously, weekly (3 weeks on/1 week off), in each 28-day treatment cycle. Participants continued to receive treatment until a lifetime cumulative dose of 500 mg/m\^2 doxorubicin, a maximum dose of paclitaxel per standard of care, or until disease progression, development of unacceptable toxicity, withdrawal of consent, or sponsor termination of the study.
|
|---|---|---|
|
PFS Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Based on BICR in All-comer Participants
|
7.2 Months
95% Confidence Interval 5.7 • Interval 5.7 to 7.6
|
3.8 Months
95% Confidence Interval 3.6 • Interval 3.6 to 4.2
|
PRIMARY outcome
Timeframe: Up to approximately 43 monthsPopulation: Analysis population consisted of ITT population which included all randomized participants. Data is reported for pMMR participants.
OS was defined as the time from the date of randomization to the date of death due to any cause. Participants who were lost to follow-up and those who were alive at the date of data cut-off were censored at the date the participant was last known alive, or date of data cut-off, whichever occurred first.
Outcome measures
| Measure |
Lenvatinib 20 mg + Pembrolizumab 200 mg
n=346 Participants
Participants with Endometrial cancer (EC) received lenvatinib 20 milligrams (mg) orally, once daily, plus pembrolizumab 200 mg intravenously, every 3 weeks in each 21-day cycle. Participants continued to receive treatment until disease progression, development of unacceptable toxicity, withdrawal of consent, completion of 35 treatments (approximately 2 years) with pembrolizumab, or sponsor termination of the study
|
Treatment of Physician's Choice (TPC): Doxorubicin or Paclitaxel
n=351 Participants
Participants with EC received either doxorubicin 60 milligrams per square meter (mg/m\^2) intravenously, every 3 weeks, in each 21-day treatment cycle, or paclitaxel 80 mg/m\^2 intravenously, weekly (3 weeks on/1 week off), in each 28-day treatment cycle. Participants continued to receive treatment until a lifetime cumulative dose of 500 mg/m\^2 doxorubicin, a maximum dose of paclitaxel per standard of care, or until disease progression, development of unacceptable toxicity, withdrawal of consent, or sponsor termination of the study.
|
|---|---|---|
|
Overall Survival (OS) in pMMR Participants
|
18.0 Months
Interval 14.9 to 20.5
|
12.2 Months
Interval 11.0 to 14.1
|
PRIMARY outcome
Timeframe: Up to approximately 43 monthsPopulation: Analysis population consisted of ITT population which included all randomized participants.
OS was defined as the time from the date of randomization to the date of death due to any cause. Participants who were lost to follow-up and those who were alive at the date of data cut-off were censored at the date the participant was last known alive, or date of data cut-off, whichever occurred first.
Outcome measures
| Measure |
Lenvatinib 20 mg + Pembrolizumab 200 mg
n=411 Participants
Participants with Endometrial cancer (EC) received lenvatinib 20 milligrams (mg) orally, once daily, plus pembrolizumab 200 mg intravenously, every 3 weeks in each 21-day cycle. Participants continued to receive treatment until disease progression, development of unacceptable toxicity, withdrawal of consent, completion of 35 treatments (approximately 2 years) with pembrolizumab, or sponsor termination of the study
|
Treatment of Physician's Choice (TPC): Doxorubicin or Paclitaxel
n=416 Participants
Participants with EC received either doxorubicin 60 milligrams per square meter (mg/m\^2) intravenously, every 3 weeks, in each 21-day treatment cycle, or paclitaxel 80 mg/m\^2 intravenously, weekly (3 weeks on/1 week off), in each 28-day treatment cycle. Participants continued to receive treatment until a lifetime cumulative dose of 500 mg/m\^2 doxorubicin, a maximum dose of paclitaxel per standard of care, or until disease progression, development of unacceptable toxicity, withdrawal of consent, or sponsor termination of the study.
|
|---|---|---|
|
OS in All-comer Participants
|
18.7 Months
95% Confidence Interval 15.6 • Interval 15.6 to 21.3
|
11.9 Months
95% Confidence Interval 10.7 • Interval 10.7 to 13.3
|
SECONDARY outcome
Timeframe: Up to approximately 80 monthsPopulation: Analysis population consisted of ITT population which included all randomized participants. Data is reported for pMMR participants.
ORR was defined as the percentage of participants who had best overall response of either complete response (CR) or partial response (PR) as determined by BICR per RECIST 1.1. CR was defined as the disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis to less than (\<) 10mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.
Outcome measures
| Measure |
Lenvatinib 20 mg + Pembrolizumab 200 mg
n=346 Participants
Participants with Endometrial cancer (EC) received lenvatinib 20 milligrams (mg) orally, once daily, plus pembrolizumab 200 mg intravenously, every 3 weeks in each 21-day cycle. Participants continued to receive treatment until disease progression, development of unacceptable toxicity, withdrawal of consent, completion of 35 treatments (approximately 2 years) with pembrolizumab, or sponsor termination of the study
|
Treatment of Physician's Choice (TPC): Doxorubicin or Paclitaxel
n=351 Participants
Participants with EC received either doxorubicin 60 milligrams per square meter (mg/m\^2) intravenously, every 3 weeks, in each 21-day treatment cycle, or paclitaxel 80 mg/m\^2 intravenously, weekly (3 weeks on/1 week off), in each 28-day treatment cycle. Participants continued to receive treatment until a lifetime cumulative dose of 500 mg/m\^2 doxorubicin, a maximum dose of paclitaxel per standard of care, or until disease progression, development of unacceptable toxicity, withdrawal of consent, or sponsor termination of the study.
|
|---|---|---|
|
Objective Response Rate (ORR) in pMMR Participants
|
30.3 Percentage of participants
95% Confidence Interval 25.5 • Interval 25.5 to 35.5
|
15.1 Percentage of participants
95% Confidence Interval 11.5 • Interval 11.5 to 19.3
|
SECONDARY outcome
Timeframe: Up to approximately 80 monthsPopulation: Analysis population consisted of ITT population which included all randomized participants.
ORR was defined as the percentage of participants who had best overall response of either complete response (CR) or partial response (PR) as determined by BICR per RECIST 1.1. CR was defined as the disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis to less than (\<) 10mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.
Outcome measures
| Measure |
Lenvatinib 20 mg + Pembrolizumab 200 mg
n=411 Participants
Participants with Endometrial cancer (EC) received lenvatinib 20 milligrams (mg) orally, once daily, plus pembrolizumab 200 mg intravenously, every 3 weeks in each 21-day cycle. Participants continued to receive treatment until disease progression, development of unacceptable toxicity, withdrawal of consent, completion of 35 treatments (approximately 2 years) with pembrolizumab, or sponsor termination of the study
|
Treatment of Physician's Choice (TPC): Doxorubicin or Paclitaxel
n=416 Participants
Participants with EC received either doxorubicin 60 milligrams per square meter (mg/m\^2) intravenously, every 3 weeks, in each 21-day treatment cycle, or paclitaxel 80 mg/m\^2 intravenously, weekly (3 weeks on/1 week off), in each 28-day treatment cycle. Participants continued to receive treatment until a lifetime cumulative dose of 500 mg/m\^2 doxorubicin, a maximum dose of paclitaxel per standard of care, or until disease progression, development of unacceptable toxicity, withdrawal of consent, or sponsor termination of the study.
|
|---|---|---|
|
ORR in All-comer Participants
|
31.9 Percentage of Participants
95% Confidence Interval 27.4 • Interval 27.4 to 36.6
|
14.7 Percentage of Participants
95% Confidence Interval 11.4 • Interval 11.4 to 18.4
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Analysis population consisted of ITT population which included all randomized participants. Data is reported for pMMR participants. Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.
EORTC QLQ-C30 was a questionnaire which included 30 questions that rates the overall quality of life in cancer participants. The first 28 questions use a 4-point scale (1=not at all to 4=very much) for evaluating function (physical, role, social, cognitive, emotional), symptoms (diarrhea, fatigue, dyspnea, appetite loss, insomnia, nausea/vomiting, constipation, and pain) and financial difficulties. The last 2 questions use a 7-point scale (1=very poor to 7=excellent) to evaluate overall health and quality of life. Scores are transformed to a range of 0 to 100 using a standard EORTC algorithm. A high score for a functional scale represents a high/healthy level of functioning, a high score for the global health status/quality of life (QoL) represents a high QoL, but a high score for a symptom scale/item represents a high level of symptomatology/problem.
Outcome measures
| Measure |
Lenvatinib 20 mg + Pembrolizumab 200 mg
n=327 Participants
Participants with Endometrial cancer (EC) received lenvatinib 20 milligrams (mg) orally, once daily, plus pembrolizumab 200 mg intravenously, every 3 weeks in each 21-day cycle. Participants continued to receive treatment until disease progression, development of unacceptable toxicity, withdrawal of consent, completion of 35 treatments (approximately 2 years) with pembrolizumab, or sponsor termination of the study
|
Treatment of Physician's Choice (TPC): Doxorubicin or Paclitaxel
n=310 Participants
Participants with EC received either doxorubicin 60 milligrams per square meter (mg/m\^2) intravenously, every 3 weeks, in each 21-day treatment cycle, or paclitaxel 80 mg/m\^2 intravenously, weekly (3 weeks on/1 week off), in each 28-day treatment cycle. Participants continued to receive treatment until a lifetime cumulative dose of 500 mg/m\^2 doxorubicin, a maximum dose of paclitaxel per standard of care, or until disease progression, development of unacceptable toxicity, withdrawal of consent, or sponsor termination of the study.
|
|---|---|---|
|
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) in pMMR Participants
|
-6.80 Score on a scale
95% Confidence Interval -9.43 • Interval -9.43 to -4.17
|
-7.96 Score on a scale
95% Confidence Interval -10.86 • Interval -10.86 to -5.05
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Analysis population consisted of ITT population which included all randomized participants. Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.
EORTC QLQ-C30 was a questionnaire which included 30 questions that rates the overall quality of life in cancer participants. The first 28 questions use a 4-point scale (1=not at all to 4=very much) for evaluating function (physical, role, social, cognitive, emotional), symptoms (diarrhea, fatigue, dyspnea, appetite loss, insomnia, nausea/vomiting, constipation, and pain) and financial difficulties. The last 2 questions use a 7-point scale (1=very poor to 7=excellent) to evaluate overall health and quality of life. Scores are transformed to a range of 0 to 100 using a standard EORTC algorithm. A high score for a functional scale represents a high/healthy level of functioning, a high score for the global health status/quality of life (QoL) represents a high QoL, but a high score for a symptom scale/item represents a high level of symptomatology/problem.
Outcome measures
| Measure |
Lenvatinib 20 mg + Pembrolizumab 200 mg
n=386 Participants
Participants with Endometrial cancer (EC) received lenvatinib 20 milligrams (mg) orally, once daily, plus pembrolizumab 200 mg intravenously, every 3 weeks in each 21-day cycle. Participants continued to receive treatment until disease progression, development of unacceptable toxicity, withdrawal of consent, completion of 35 treatments (approximately 2 years) with pembrolizumab, or sponsor termination of the study
|
Treatment of Physician's Choice (TPC): Doxorubicin or Paclitaxel
n=363 Participants
Participants with EC received either doxorubicin 60 milligrams per square meter (mg/m\^2) intravenously, every 3 weeks, in each 21-day treatment cycle, or paclitaxel 80 mg/m\^2 intravenously, weekly (3 weeks on/1 week off), in each 28-day treatment cycle. Participants continued to receive treatment until a lifetime cumulative dose of 500 mg/m\^2 doxorubicin, a maximum dose of paclitaxel per standard of care, or until disease progression, development of unacceptable toxicity, withdrawal of consent, or sponsor termination of the study.
|
|---|---|---|
|
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) in All-comer Participants
|
-5.97 Score on a scale
95% Confidence Interval -8.36 • Interval -8.36 to -3.58
|
-6.98 Score on a scale
95% Confidence Interval -9.63 • Interval -9.63 to -4.33
|
SECONDARY outcome
Timeframe: Up to approximately 77 monthsPopulation: The analysis population included all randomized participants who received at least 1 dose of study treatment.
TEAEs were AEs that occurred (or worsened, if present at baseline) after the first dose of study drug through 28 days after the last dose. An AE was any untoward medical occurrence in a participant temporally associated with use of study treatment, whether or not related to the treatment. An SAE was any untoward medical occurrence at any dose that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, or was a congenital anomaly/birth defect. An irAE was any unfavorable and unintended immune-related sign, symptom, or disease (new or worsening) temporally associated with study therapy, regardless of whether a causal relationship with the therapy could be determined.
Outcome measures
| Measure |
Lenvatinib 20 mg + Pembrolizumab 200 mg
n=406 Participants
Participants with Endometrial cancer (EC) received lenvatinib 20 milligrams (mg) orally, once daily, plus pembrolizumab 200 mg intravenously, every 3 weeks in each 21-day cycle. Participants continued to receive treatment until disease progression, development of unacceptable toxicity, withdrawal of consent, completion of 35 treatments (approximately 2 years) with pembrolizumab, or sponsor termination of the study
|
Treatment of Physician's Choice (TPC): Doxorubicin or Paclitaxel
n=388 Participants
Participants with EC received either doxorubicin 60 milligrams per square meter (mg/m\^2) intravenously, every 3 weeks, in each 21-day treatment cycle, or paclitaxel 80 mg/m\^2 intravenously, weekly (3 weeks on/1 week off), in each 28-day treatment cycle. Participants continued to receive treatment until a lifetime cumulative dose of 500 mg/m\^2 doxorubicin, a maximum dose of paclitaxel per standard of care, or until disease progression, development of unacceptable toxicity, withdrawal of consent, or sponsor termination of the study.
|
|---|---|---|
|
Number of Partricipants With Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Immune-Related Adverse Events (irAEs)
|
237 Participants
|
121 Participants
|
SECONDARY outcome
Timeframe: Up to approximately 77 monthsPopulation: Safety analysis population included all randomized participants who received at least 1 dose of study treatment. Data is reported for pMMR participants. Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.
TEAEs was defined as those AEs that occurred (or worsened, if present at Baseline) after the first dose of study drug through 30 days after the last dose of study drug. An AE was defined as any untoward medical occurrence in a participants or clinical study participant temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Outcome measures
| Measure |
Lenvatinib 20 mg + Pembrolizumab 200 mg
n=342 Participants
Participants with Endometrial cancer (EC) received lenvatinib 20 milligrams (mg) orally, once daily, plus pembrolizumab 200 mg intravenously, every 3 weeks in each 21-day cycle. Participants continued to receive treatment until disease progression, development of unacceptable toxicity, withdrawal of consent, completion of 35 treatments (approximately 2 years) with pembrolizumab, or sponsor termination of the study
|
Treatment of Physician's Choice (TPC): Doxorubicin or Paclitaxel
n=325 Participants
Participants with EC received either doxorubicin 60 milligrams per square meter (mg/m\^2) intravenously, every 3 weeks, in each 21-day treatment cycle, or paclitaxel 80 mg/m\^2 intravenously, weekly (3 weeks on/1 week off), in each 28-day treatment cycle. Participants continued to receive treatment until a lifetime cumulative dose of 500 mg/m\^2 doxorubicin, a maximum dose of paclitaxel per standard of care, or until disease progression, development of unacceptable toxicity, withdrawal of consent, or sponsor termination of the study.
|
|---|---|---|
|
Number of Participants Who Discontinued Study Treatment Due to a TEAE in pMMR Participants
|
140 Participants
|
42 Participants
|
SECONDARY outcome
Timeframe: Up to approximately 77 monthsPopulation: Safety analysis population included all randomized participants who received at least 1 dose of study treatment.
TEAEs was defined as those AEs that occurred (or worsened, if present at Baseline) after the first dose of study drug through 30 days after the last dose of study drug. An AE was defined as any untoward medical occurrence in a participants or clinical study participant temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Outcome measures
| Measure |
Lenvatinib 20 mg + Pembrolizumab 200 mg
n=406 Participants
Participants with Endometrial cancer (EC) received lenvatinib 20 milligrams (mg) orally, once daily, plus pembrolizumab 200 mg intravenously, every 3 weeks in each 21-day cycle. Participants continued to receive treatment until disease progression, development of unacceptable toxicity, withdrawal of consent, completion of 35 treatments (approximately 2 years) with pembrolizumab, or sponsor termination of the study
|
Treatment of Physician's Choice (TPC): Doxorubicin or Paclitaxel
n=388 Participants
Participants with EC received either doxorubicin 60 milligrams per square meter (mg/m\^2) intravenously, every 3 weeks, in each 21-day treatment cycle, or paclitaxel 80 mg/m\^2 intravenously, weekly (3 weeks on/1 week off), in each 28-day treatment cycle. Participants continued to receive treatment until a lifetime cumulative dose of 500 mg/m\^2 doxorubicin, a maximum dose of paclitaxel per standard of care, or until disease progression, development of unacceptable toxicity, withdrawal of consent, or sponsor termination of the study.
|
|---|---|---|
|
Number of Participants Who Discontinued Study Treatment Due to a TEAE in All-comer Participants
|
180 Participants
|
49 Participants
|
SECONDARY outcome
Timeframe: Up to approximately 77 monthsPopulation: Safety analysis population included all randomized participants who received at least 1 dose of study treatment. Data is reported for pMMR participants. Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.
Time to treatment failure due to toxicity was defined as the time from the date of randomization to the date a participant discontinued study treatment due to TEAEs.
Outcome measures
| Measure |
Lenvatinib 20 mg + Pembrolizumab 200 mg
n=342 Participants
Participants with Endometrial cancer (EC) received lenvatinib 20 milligrams (mg) orally, once daily, plus pembrolizumab 200 mg intravenously, every 3 weeks in each 21-day cycle. Participants continued to receive treatment until disease progression, development of unacceptable toxicity, withdrawal of consent, completion of 35 treatments (approximately 2 years) with pembrolizumab, or sponsor termination of the study
|
Treatment of Physician's Choice (TPC): Doxorubicin or Paclitaxel
n=325 Participants
Participants with EC received either doxorubicin 60 milligrams per square meter (mg/m\^2) intravenously, every 3 weeks, in each 21-day treatment cycle, or paclitaxel 80 mg/m\^2 intravenously, weekly (3 weeks on/1 week off), in each 28-day treatment cycle. Participants continued to receive treatment until a lifetime cumulative dose of 500 mg/m\^2 doxorubicin, a maximum dose of paclitaxel per standard of care, or until disease progression, development of unacceptable toxicity, withdrawal of consent, or sponsor termination of the study.
|
|---|---|---|
|
Time to Treatment Failure Due to Toxicity in pMMR Participants
|
429.6 Months
Standard Deviation 491.6 • Interval 491.6 to
|
260.1 Months
Standard Deviation 356.2 • Interval 356.2 to
|
SECONDARY outcome
Timeframe: Up to approximately 77 monthsPopulation: Safety analysis population included all randomized participants who received at least 1 dose of study treatment.
Time to treatment failure due to toxicity was defined as the time from the date of randomization to the date a participant discontinued study treatment due to TEAEs.
Outcome measures
| Measure |
Lenvatinib 20 mg + Pembrolizumab 200 mg
n=406 Participants
Participants with Endometrial cancer (EC) received lenvatinib 20 milligrams (mg) orally, once daily, plus pembrolizumab 200 mg intravenously, every 3 weeks in each 21-day cycle. Participants continued to receive treatment until disease progression, development of unacceptable toxicity, withdrawal of consent, completion of 35 treatments (approximately 2 years) with pembrolizumab, or sponsor termination of the study
|
Treatment of Physician's Choice (TPC): Doxorubicin or Paclitaxel
n=388 Participants
Participants with EC received either doxorubicin 60 milligrams per square meter (mg/m\^2) intravenously, every 3 weeks, in each 21-day treatment cycle, or paclitaxel 80 mg/m\^2 intravenously, weekly (3 weeks on/1 week off), in each 28-day treatment cycle. Participants continued to receive treatment until a lifetime cumulative dose of 500 mg/m\^2 doxorubicin, a maximum dose of paclitaxel per standard of care, or until disease progression, development of unacceptable toxicity, withdrawal of consent, or sponsor termination of the study.
|
|---|---|---|
|
Time to Treatment Failure Due to Toxicity in All-comer Participants
|
456.5 Months
Standard Deviation 520.6 • Interval 520.6 to
|
259.7 Months
Standard Deviation 369.5 • Interval 369.5 to
|
SECONDARY outcome
Timeframe: Cycle 1 day 1 0.5-4 hours (h), 6-10 postdose; Cycle 1 day 15 predose; Cycle 1 day 15 2-12h postdose, Cycle 2 day 1 predose, 0.5-4h, 6-10 h (Each cycle is 21 days)Population: Analysis population included all participants who have received at least 1 dose of study treatment with documented dosing history in the lenvatinib plus pembrolizumab arm and have measurable plasma levels of lenvatinib. Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies participants evaluable at specific timepoints.
Pharmacokinetic (PK) samples were collected and analyzed using a population PK approach to estimate PK parameters. Individual predicted plasma concentration of lenvatinib was then derived from the PK model.
Outcome measures
| Measure |
Lenvatinib 20 mg + Pembrolizumab 200 mg
n=403 Participants
Participants with Endometrial cancer (EC) received lenvatinib 20 milligrams (mg) orally, once daily, plus pembrolizumab 200 mg intravenously, every 3 weeks in each 21-day cycle. Participants continued to receive treatment until disease progression, development of unacceptable toxicity, withdrawal of consent, completion of 35 treatments (approximately 2 years) with pembrolizumab, or sponsor termination of the study
|
Treatment of Physician's Choice (TPC): Doxorubicin or Paclitaxel
Participants with EC received either doxorubicin 60 milligrams per square meter (mg/m\^2) intravenously, every 3 weeks, in each 21-day treatment cycle, or paclitaxel 80 mg/m\^2 intravenously, weekly (3 weeks on/1 week off), in each 28-day treatment cycle. Participants continued to receive treatment until a lifetime cumulative dose of 500 mg/m\^2 doxorubicin, a maximum dose of paclitaxel per standard of care, or until disease progression, development of unacceptable toxicity, withdrawal of consent, or sponsor termination of the study.
|
|---|---|---|
|
Plasma Concentration of Lenvatinib Versus Time in All-comer Participants
Cycle 2 Day 1, Pre-dose
|
67.2 nanograms per milliliter (ng/mL)
Standard Deviation 74.7
|
—
|
|
Plasma Concentration of Lenvatinib Versus Time in All-comer Participants
Cycle 2 Day 1, 0.5-4h
|
151 nanograms per milliliter (ng/mL)
Standard Deviation 155
|
—
|
|
Plasma Concentration of Lenvatinib Versus Time in All-comer Participants
Cycle 1 Day 1, 0.5-4h Post-dose
|
152 nanograms per milliliter (ng/mL)
Standard Deviation 181
|
—
|
|
Plasma Concentration of Lenvatinib Versus Time in All-comer Participants
Cycle 1 Day 1, 6-10 h Post-dose
|
258 nanograms per milliliter (ng/mL)
Standard Deviation 124
|
—
|
|
Plasma Concentration of Lenvatinib Versus Time in All-comer Participants
Cycle 1 Day 15, Pre-dose
|
89.1 nanograms per milliliter (ng/mL)
Standard Deviation 69.6
|
—
|
|
Plasma Concentration of Lenvatinib Versus Time in All-comer Participants
Cycle 1 Day 15, 2-12 h Post-dose
|
310 nanograms per milliliter (ng/mL)
Standard Deviation 218
|
—
|
|
Plasma Concentration of Lenvatinib Versus Time in All-comer Participants
Cycle 2 Day 1, 6-10 h
|
258 nanograms per milliliter (ng/mL)
Standard Deviation 138
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 day 1 0.5-4 hour (h), 6-10 postdose; Cycle 1 day 15 predose; Cycle 1 day 15 2-12h postdose, Cycle 2 day 1 predose, 0.5-4h, 6-10 h (Each cycle is 21 days)Population: Analysis population included all participants who have received at least 1 dose of study treatment with documented dosing history in the lenvatinib plus pembrolizumab arm and have measurable plasma levels of lenvatinib. Data is reported for pMMR participants. Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies participants evaluable at specific timepoints.
PK samples were collected and analyzed using a population PK approach to estimate PK parameters. Individual predicted plasma concentration of lenvatinib was then derived from the PK model.
Outcome measures
| Measure |
Lenvatinib 20 mg + Pembrolizumab 200 mg
n=63 Participants
Participants with Endometrial cancer (EC) received lenvatinib 20 milligrams (mg) orally, once daily, plus pembrolizumab 200 mg intravenously, every 3 weeks in each 21-day cycle. Participants continued to receive treatment until disease progression, development of unacceptable toxicity, withdrawal of consent, completion of 35 treatments (approximately 2 years) with pembrolizumab, or sponsor termination of the study
|
Treatment of Physician's Choice (TPC): Doxorubicin or Paclitaxel
Participants with EC received either doxorubicin 60 milligrams per square meter (mg/m\^2) intravenously, every 3 weeks, in each 21-day treatment cycle, or paclitaxel 80 mg/m\^2 intravenously, weekly (3 weeks on/1 week off), in each 28-day treatment cycle. Participants continued to receive treatment until a lifetime cumulative dose of 500 mg/m\^2 doxorubicin, a maximum dose of paclitaxel per standard of care, or until disease progression, development of unacceptable toxicity, withdrawal of consent, or sponsor termination of the study.
|
|---|---|---|
|
Plasma Concentration of Lenvatinib Versus Time in pMMR Participants
Cycle 2 Day 1, 6-10 h
|
278 ng/mL
Standard Deviation 132
|
—
|
|
Plasma Concentration of Lenvatinib Versus Time in pMMR Participants
Cycle 1 Day 1, 0.5-4 h Post-dose
|
140 ng/mL
Standard Deviation 180
|
—
|
|
Plasma Concentration of Lenvatinib Versus Time in pMMR Participants
Cycle 1 Day 1, 6-10 h Post-dose
|
283 ng/mL
Standard Deviation 136
|
—
|
|
Plasma Concentration of Lenvatinib Versus Time in pMMR Participants
Cycle 1 Day 15, Pre-dose
|
93.8 ng/mL
Standard Deviation 61.4
|
—
|
|
Plasma Concentration of Lenvatinib Versus Time in pMMR Participants
Cycle 1 Day 15, 2-12 h Post-dose
|
335 ng/mL
Standard Deviation 256
|
—
|
|
Plasma Concentration of Lenvatinib Versus Time in pMMR Participants
Cycle 2 Day 1, Pre-dose
|
67.9 ng/mL
Standard Deviation 60.9
|
—
|
|
Plasma Concentration of Lenvatinib Versus Time in pMMR Participants
Cycle 2 Day 1, 0.5-4 h
|
153 ng/mL
Standard Deviation 127
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1: 0.5-10 hours post-dose; Cycle 1 Day 15: 0-12 hours post-dose; Cycle 2 Day 1: 0.5-10 hours post-dose (each cycle length=21 days)Population: The population pharmacokinetic analysis set includes all the participants who have received at least 1 dose of study treatment with documented dosing history in the lenvatinib plus pembrolizumab arm, and have measurable plasma levels of lenvatinib. Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.
Sparse pharmacokinetic (PK) samples were collected and analyzed using a population PK approach to estimate PK parameters. Individual predicted CL/F for lenvatinib was then derived from the PK model. The data was collected and analyzed for lenvatinib plus pembrolizumab arm only.
Outcome measures
| Measure |
Lenvatinib 20 mg + Pembrolizumab 200 mg
n=403 Participants
Participants with Endometrial cancer (EC) received lenvatinib 20 milligrams (mg) orally, once daily, plus pembrolizumab 200 mg intravenously, every 3 weeks in each 21-day cycle. Participants continued to receive treatment until disease progression, development of unacceptable toxicity, withdrawal of consent, completion of 35 treatments (approximately 2 years) with pembrolizumab, or sponsor termination of the study
|
Treatment of Physician's Choice (TPC): Doxorubicin or Paclitaxel
Participants with EC received either doxorubicin 60 milligrams per square meter (mg/m\^2) intravenously, every 3 weeks, in each 21-day treatment cycle, or paclitaxel 80 mg/m\^2 intravenously, weekly (3 weeks on/1 week off), in each 28-day treatment cycle. Participants continued to receive treatment until a lifetime cumulative dose of 500 mg/m\^2 doxorubicin, a maximum dose of paclitaxel per standard of care, or until disease progression, development of unacceptable toxicity, withdrawal of consent, or sponsor termination of the study.
|
|---|---|---|
|
Model Predicted Apparent Total Clearance (CL/F) for Lenvatinib
|
4.69 liter per hour (L/h)
Standard Deviation 1.39
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1: 0.5-10 hours post-dose; Cycle 1 Day 15: 0-12 hours post-dose; Cycle 2 Day 1: 0.5-10 hours post-dose (each cycle length=21 days)Population: The population pharmacokinetic analysis set includes all the participants who have received at least 1 dose of study treatment with documented dosing history in the lenvatinib plus pembrolizumab arm, and have measurable plasma levels of lenvatinib. Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.
Sparse PK samples were collected and analyzed using a population PK approach to estimate PK parameters. Individual predicted AUC for lenvatinib was then derived from the PK model. The data was collected and analyzed for lenvatinib plus pembrolizumab arm only.
Outcome measures
| Measure |
Lenvatinib 20 mg + Pembrolizumab 200 mg
n=403 Participants
Participants with Endometrial cancer (EC) received lenvatinib 20 milligrams (mg) orally, once daily, plus pembrolizumab 200 mg intravenously, every 3 weeks in each 21-day cycle. Participants continued to receive treatment until disease progression, development of unacceptable toxicity, withdrawal of consent, completion of 35 treatments (approximately 2 years) with pembrolizumab, or sponsor termination of the study
|
Treatment of Physician's Choice (TPC): Doxorubicin or Paclitaxel
Participants with EC received either doxorubicin 60 milligrams per square meter (mg/m\^2) intravenously, every 3 weeks, in each 21-day treatment cycle, or paclitaxel 80 mg/m\^2 intravenously, weekly (3 weeks on/1 week off), in each 28-day treatment cycle. Participants continued to receive treatment until a lifetime cumulative dose of 500 mg/m\^2 doxorubicin, a maximum dose of paclitaxel per standard of care, or until disease progression, development of unacceptable toxicity, withdrawal of consent, or sponsor termination of the study.
|
|---|---|---|
|
Model Predicted Area Under the Plasma Drug Concentration-time Curve (AUC) for Lenvatinib
|
4134 nanogram*hour per milliliter (ng*h/mL)
Standard Deviation 1350
|
—
|
Adverse Events
First Course: Lenvatinib + Pembrolizumab
Serious events: 237 serious events
Other events: 404 other events
Deaths: 317 deaths
First Course: TPC Doxorubicin or Paclitaxel
Serious events: 121 serious events
Other events: 379 other events
Deaths: 362 deaths
Second Course: Lenvatinib + Pembrolizumab
Serious events: 4 serious events
Other events: 20 other events
Deaths: 8 deaths
TPC Crossover
Serious events: 1 serious events
Other events: 6 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
First Course: Lenvatinib + Pembrolizumab
n=406 participants at risk
Participants with Endometrial cancer (EC) received lenvatinib 20 milligrams (mg) orally, once daily, plus pembrolizumab 200 mg intravenously, every 3 weeks in each 21-day cycle. Participants continued to receive treatment until disease progression, development of unacceptable toxicity, withdrawal of consent, completion of 35 treatments (approximately 2 years) with pembrolizumab, or sponsor termination of the study
|
First Course: TPC Doxorubicin or Paclitaxel
n=388 participants at risk
Participants with EC received either doxorubicin 60 milligrams per square meter (mg/m\^2) intravenously, every 3 weeks, in each 21-day treatment cycle, or paclitaxel 80 mg/m\^2 intravenously, weekly (3 weeks on/1 week off), in each 28-day treatment cycle. Participants continued to receive treatment until a lifetime cumulative dose of 500 mg/m\^2 doxorubicin, a maximum dose of paclitaxel per standard of care, or until disease progression, development of unacceptable toxicity, withdrawal of consent, or sponsor termination of the study.
|
Second Course: Lenvatinib + Pembrolizumab
n=21 participants at risk
Eligible participants who completed the first course of up to 35 administrations of pembrolizumab (\~2 years) and lenvatinib (\~2years) or who had Stable disease (SD) or partial response (PR) or had attained complete response (CR), but experienced radiologic progression of disease (PD) initiated a second course of pembrolizumab and lenvatinib at investigators discretion at the same dose and schedule at lenvatinib 20 mg orally, once daily, plus pembrolizumab 200 mg intravenously, every 3 weeks in each 21-day cycle upto 17 cycles (upto \~1 year)
|
TPC Crossover
n=6 participants at risk
Eligible participants who completed the first course of either doxorubicin 60 milligrams per square meter (mg/m\^2) intravenously, every 3 weeks, in each 21-day treatment cycle, or paclitaxel 80 mg/m\^2 intravenously, weekly (3 weeks on/1 week off), in each 28-day treatment cycle and eligible participants continued to receive treatment until a lifetime cumulative dose of 500 mg/m\^2 doxorubicin, a maximum dose of paclitaxel per standard of care or who had Stable disease (SD) or partial response (PR) or had attained complete response (CR), but experienced radiologic progression of disease (PD) initiated treatment with pembrolizumab and lenvatinib at investigators discretion at the same dose and schedule at lenvatinib 20 mg orally, once daily, plus pembrolizumab 200 mg intravenously, every 3 weeks in each 21-day cycle upto 17 cycles (upto \~1 year)
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
2.3%
9/388 • Number of events 9 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Blood and lymphatic system disorders
Febrile bone marrow aplasia
|
0.00%
0/406 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.26%
1/388 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.49%
2/406 • Number of events 2 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
4.1%
16/388 • Number of events 17 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/406 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.26%
1/388 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/406 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.52%
2/388 • Number of events 2 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
2.1%
8/388 • Number of events 8 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Blood and lymphatic system disorders
Neutrophilia
|
0.00%
0/406 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.26%
1/388 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.26%
1/388 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Blood and lymphatic system disorders
Thrombotic microangiopathy
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.49%
2/406 • Number of events 2 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.74%
3/406 • Number of events 3 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Cardiac disorders
Atrial fibrillation
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.52%
2/388 • Number of events 2 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Cardiac disorders
Bundle branch block left
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/406 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.77%
3/388 • Number of events 3 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/406 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.52%
2/388 • Number of events 2 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Cardiac disorders
Cardiogenic shock
|
0.00%
0/406 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.77%
3/388 • Number of events 3 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.00%
0/406 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.26%
1/388 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Cardiac disorders
Myocardial infarction
|
0.49%
2/406 • Number of events 2 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Cardiac disorders
Myocarditis
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Cardiac disorders
Pericardial effusion
|
0.74%
3/406 • Number of events 3 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Cardiac disorders
Right ventricular dysfunction
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Cardiac disorders
Sinus tachycardia
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Cardiac disorders
Stress cardiomyopathy
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/406 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.52%
2/388 • Number of events 3 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Cardiac disorders
Toxic cardiomyopathy
|
0.00%
0/406 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.26%
1/388 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Cardiac disorders
Ventricular fibrillation
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.74%
3/406 • Number of events 3 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
16.7%
1/6 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Endocrine disorders
Adrenocorticotropic hormone deficiency
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Endocrine disorders
Hyperthyroidism
|
0.74%
3/406 • Number of events 3 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Endocrine disorders
Hypophysitis
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Endocrine disorders
Hypothyroidism
|
0.49%
2/406 • Number of events 2 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Eye disorders
Iridocyclitis
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.99%
4/406 • Number of events 4 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.26%
1/388 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Gastrointestinal disorders
Anal fissure
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Gastrointestinal disorders
Ascites
|
0.49%
2/406 • Number of events 2 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.77%
3/388 • Number of events 3 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Gastrointestinal disorders
Colitis
|
1.7%
7/406 • Number of events 7 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.26%
1/388 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
4.8%
1/21 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Gastrointestinal disorders
Colonic fistula
|
0.00%
0/406 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.52%
2/388 • Number of events 2 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Gastrointestinal disorders
Constipation
|
0.74%
3/406 • Number of events 4 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.5%
10/406 • Number of events 10 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.77%
3/388 • Number of events 3 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Gastrointestinal disorders
Duodenal obstruction
|
0.00%
0/406 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.26%
1/388 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.49%
2/406 • Number of events 2 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Gastrointestinal disorders
Gastrointestinal perforation
|
0.74%
3/406 • Number of events 3 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Gastrointestinal disorders
Gastrointestinal toxicity
|
0.00%
0/406 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.26%
1/388 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Gastrointestinal disorders
Ileus
|
0.99%
4/406 • Number of events 5 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Gastrointestinal disorders
Immune-mediated pancreatitis
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Gastrointestinal disorders
Intestinal fistula
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.99%
4/406 • Number of events 4 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.49%
2/406 • Number of events 2 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Gastrointestinal disorders
Lower gastrointestinal perforation
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Gastrointestinal disorders
Malignant gastrointestinal obstruction
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Gastrointestinal disorders
Mechanical ileus
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Gastrointestinal disorders
Nausea
|
0.74%
3/406 • Number of events 3 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.26%
1/388 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.49%
2/406 • Number of events 2 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Gastrointestinal disorders
Proctalgia
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Gastrointestinal disorders
Rectal perforation
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.74%
3/406 • Number of events 3 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.52%
2/388 • Number of events 4 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/406 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.26%
1/388 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Gastrointestinal disorders
Subileus
|
0.49%
2/406 • Number of events 2 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.26%
1/388 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Gastrointestinal disorders
Vomiting
|
2.2%
9/406 • Number of events 9 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.77%
3/388 • Number of events 4 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Hepatobiliary disorders
Biliary obstruction
|
0.49%
2/406 • Number of events 2 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Hepatobiliary disorders
Cholangitis
|
0.99%
4/406 • Number of events 5 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Hepatobiliary disorders
Cholecystitis
|
2.0%
8/406 • Number of events 10 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.49%
2/406 • Number of events 2 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Hepatobiliary disorders
Hepatitis
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Hepatobiliary disorders
Hepatobiliary disease
|
0.00%
0/406 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.26%
1/388 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Hepatobiliary disorders
Hepatotoxicity
|
0.25%
1/406 • Number of events 2 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Hepatobiliary disorders
Immune-mediated hepatitis
|
0.49%
2/406 • Number of events 4 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Hepatobiliary disorders
Liver disorder
|
0.49%
2/406 • Number of events 2 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Immune system disorders
Anaphylactic reaction
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Immune system disorders
Anaphylactic shock
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Immune system disorders
Hypersensitivity
|
0.74%
3/406 • Number of events 4 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Infections and infestations
Abdominal sepsis
|
0.00%
0/406 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.26%
1/388 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Infections and infestations
Appendicitis
|
0.49%
2/406 • Number of events 2 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Infections and infestations
Appendicitis perforated
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Infections and infestations
Arthritis bacterial
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Infections and infestations
Bacteraemia
|
0.25%
1/406 • Number of events 2 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.52%
2/388 • Number of events 2 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Infections and infestations
Bacterial infection
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/406 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.52%
2/388 • Number of events 2 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Infections and infestations
Cystitis
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Infections and infestations
Device related infection
|
0.74%
3/406 • Number of events 3 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.52%
2/388 • Number of events 2 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Infections and infestations
Diarrhoea infectious
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Infections and infestations
Encephalitis
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Infections and infestations
Escherichia bacteraemia
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Infections and infestations
Gastroenteritis
|
0.74%
3/406 • Number of events 3 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.26%
1/388 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Infections and infestations
Gastroenteritis Escherichia coli
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Infections and infestations
Gastroenteritis norovirus
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Infections and infestations
Infected fistula
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Infections and infestations
Infection
|
0.49%
2/406 • Number of events 2 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.26%
1/388 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Infections and infestations
Influenza
|
0.49%
2/406 • Number of events 2 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.52%
2/388 • Number of events 2 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Infections and infestations
Meningitis bacterial
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Infections and infestations
Oesophageal candidiasis
|
0.00%
0/406 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.26%
1/388 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Infections and infestations
Pelvic abscess
|
0.00%
0/406 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.26%
1/388 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Infections and infestations
Peritonitis
|
0.49%
2/406 • Number of events 2 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Infections and infestations
Pneumonia
|
1.5%
6/406 • Number of events 6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
1.0%
4/388 • Number of events 4 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
16.7%
1/6 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Infections and infestations
Postoperative wound infection
|
0.74%
3/406 • Number of events 4 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Infections and infestations
Psoas abscess
|
0.25%
1/406 • Number of events 2 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Infections and infestations
Pyelonephritis
|
0.49%
2/406 • Number of events 2 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.52%
2/388 • Number of events 2 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/406 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.26%
1/388 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Infections and infestations
Retroperitoneal abscess
|
0.00%
0/406 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.26%
1/388 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Infections and infestations
Sepsis
|
1.5%
6/406 • Number of events 6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
1.3%
5/388 • Number of events 5 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Infections and infestations
Septic shock
|
0.00%
0/406 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.26%
1/388 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Infections and infestations
Sialoadenitis
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Infections and infestations
Sinusitis
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Infections and infestations
Skin infection
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Infections and infestations
Tonsillitis
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Infections and infestations
Urinary tract infection
|
3.4%
14/406 • Number of events 16 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.52%
2/388 • Number of events 2 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Infections and infestations
Urosepsis
|
0.49%
2/406 • Number of events 2 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.52%
2/388 • Number of events 2 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Infections and infestations
Vaginal abscess
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Infections and infestations
Vaginal infection
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Infections and infestations
Wound infection
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Injury, poisoning and procedural complications
Gastroenteritis radiation
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Injury, poisoning and procedural complications
Postoperative ileus
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/406 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.26%
1/388 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Injury, poisoning and procedural complications
Skull fractured base
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/406 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.26%
1/388 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Injury, poisoning and procedural complications
Vascular procedure complication
|
0.00%
0/406 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.26%
1/388 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Investigations
Blood creatinine increased
|
0.25%
1/406 • Number of events 2 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Investigations
ECG signs of myocardial ischaemia
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/406 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.26%
1/388 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Investigations
Lipase increased
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
2.2%
9/406 • Number of events 9 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
4.8%
1/21 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.2%
5/406 • Number of events 5 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.26%
1/388 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.26%
1/388 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.49%
2/406 • Number of events 2 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Metabolism and nutrition disorders
Hypochloraemia
|
0.00%
0/406 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.26%
1/388 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.74%
3/406 • Number of events 3 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.52%
2/388 • Number of events 2 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.49%
2/406 • Number of events 2 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.52%
2/388 • Number of events 2 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
4.8%
1/21 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/406 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.26%
1/388 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Metabolism and nutrition disorders
Type 1 diabetes mellitus
|
0.74%
3/406 • Number of events 3 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.26%
1/388 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.49%
2/406 • Number of events 2 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/406 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.26%
1/388 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Musculoskeletal and connective tissue disorders
Fistula
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.49%
2/406 • Number of events 2 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.74%
3/406 • Number of events 3 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.00%
0/406 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.26%
1/388 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma in situ
|
0.00%
0/406 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.26%
1/388 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/406 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.26%
1/388 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Nervous system disorders
Cerebral infarction
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.77%
3/388 • Number of events 3 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Nervous system disorders
Encephalitis autoimmune
|
0.25%
1/406 • Number of events 2 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/406 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.26%
1/388 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Nervous system disorders
Headache
|
0.49%
2/406 • Number of events 2 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Nervous system disorders
Migraine
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Nervous system disorders
Myasthenia gravis
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Nervous system disorders
Nervous system disorder
|
0.25%
1/406 • Number of events 2 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Nervous system disorders
Neuralgia
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Nervous system disorders
Optic neuritis
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Nervous system disorders
Seizure
|
0.00%
0/406 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.52%
2/388 • Number of events 2 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Nervous system disorders
Syncope
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.52%
2/388 • Number of events 2 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Nervous system disorders
Tremor
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Product Issues
Device dislocation
|
0.00%
0/406 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.26%
1/388 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Psychiatric disorders
Anxiety
|
0.25%
1/406 • Number of events 2 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.26%
1/388 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Psychiatric disorders
Confusional state
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Psychiatric disorders
Delirium
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.26%
1/388 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Renal and urinary disorders
Haematuria
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.26%
1/388 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Renal and urinary disorders
Haemorrhage urinary tract
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/406 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.26%
1/388 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Renal and urinary disorders
Renal failure
|
0.74%
3/406 • Number of events 3 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.26%
1/388 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Renal and urinary disorders
Renal injury
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Renal and urinary disorders
Urogenital fistula
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.26%
1/388 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Reproductive system and breast disorders
Female genital tract fistula
|
0.99%
4/406 • Number of events 4 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.26%
1/388 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Reproductive system and breast disorders
Intermenstrual bleeding
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Reproductive system and breast disorders
Uterine haemorrhage
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.49%
2/406 • Number of events 2 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/406 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.26%
1/388 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.49%
2/406 • Number of events 2 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.26%
1/388 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/406 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.26%
1/388 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.49%
2/406 • Number of events 2 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.26%
1/388 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.74%
3/406 • Number of events 4 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.99%
4/406 • Number of events 4 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
1.3%
5/388 • Number of events 5 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/406 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.26%
1/388 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.77%
3/388 • Number of events 3 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.25%
1/406 • Number of events 3 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Skin and subcutaneous tissue disorders
Stasis dermatitis
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Skin and subcutaneous tissue disorders
Stevens-Johnson syndrome
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Skin and subcutaneous tissue disorders
Toxic skin eruption
|
0.25%
1/406 • Number of events 2 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Skin and subcutaneous tissue disorders
Umbilical haemorrhage
|
0.00%
0/406 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.26%
1/388 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Vascular disorders
Aortic thrombosis
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Vascular disorders
Deep vein thrombosis
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.52%
2/388 • Number of events 2 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Vascular disorders
Hypertension
|
4.2%
17/406 • Number of events 17 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Vascular disorders
Hypotension
|
0.49%
2/406 • Number of events 2 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Vascular disorders
Jugular vein thrombosis
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Vascular disorders
Pelvic venous thrombosis
|
0.00%
0/406 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.26%
1/388 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Vascular disorders
Thrombosis
|
0.49%
2/406 • Number of events 2 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Vascular disorders
Vasculitis
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Cardiac disorders
Angina pectoris
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Gastrointestinal disorders
Enteritis
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Gastrointestinal disorders
Fistula of small intestine
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Gastrointestinal disorders
Gastritis
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
1.2%
5/406 • Number of events 5 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.77%
3/388 • Number of events 3 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Gastrointestinal disorders
Ischaemic enteritis
|
0.00%
0/406 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
4.8%
1/21 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Gastrointestinal disorders
Proctitis
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
General disorders
Asthenia
|
0.74%
3/406 • Number of events 3 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.52%
2/388 • Number of events 2 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
General disorders
Catheter site inflammation
|
0.00%
0/406 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.26%
1/388 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
General disorders
Condition aggravated
|
0.00%
0/406 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.26%
1/388 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
General disorders
Death
|
1.2%
5/406 • Number of events 5 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.77%
3/388 • Number of events 3 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
General disorders
Device related thrombosis
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
General disorders
Fatigue
|
0.49%
2/406 • Number of events 2 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
General disorders
General physical health deterioration
|
0.74%
3/406 • Number of events 3 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.26%
1/388 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
4.8%
1/21 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
General disorders
Generalised oedema
|
0.49%
2/406 • Number of events 2 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
General disorders
Hyperpyrexia
|
0.00%
0/406 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.26%
1/388 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
General disorders
Malaise
|
0.00%
0/406 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
16.7%
1/6 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
General disorders
Mucosal inflammation
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.52%
2/388 • Number of events 2 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
General disorders
Oedema peripheral
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.26%
1/388 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
General disorders
Perforated ulcer
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
General disorders
Pyrexia
|
2.0%
8/406 • Number of events 8 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.77%
3/388 • Number of events 3 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Hepatobiliary disorders
Acute hepatic failure
|
0.00%
0/406 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.26%
1/388 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Hepatobiliary disorders
Liver injury
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Infections and infestations
Anal abscess
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Infections and infestations
Biliary tract infection
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Infections and infestations
Hepatitis A
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Infections and infestations
Necrotising fasciitis
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Infections and infestations
Omphalitis
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Injury, poisoning and procedural complications
Fall
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Investigations
Hepatic enzyme increased
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myelomonocytic leukaemia
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholangiocarcinoma
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Nervous system disorders
Middle cerebral artery stroke
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Renal and urinary disorders
Acute kidney injury
|
2.2%
9/406 • Number of events 9 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.77%
3/388 • Number of events 3 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Renal and urinary disorders
Autoimmune nephritis
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Renal and urinary disorders
Renal disorder
|
0.00%
0/406 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
16.7%
1/6 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Lung opacity
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Skin and subcutaneous tissue disorders
Pyoderma gangrenosum
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Surgical and medical procedures
Assisted suicide
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Vascular disorders
Arteriosclerosis
|
0.00%
0/406 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
4.8%
1/21 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Vascular disorders
Hypovolaemic shock
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
Other adverse events
| Measure |
First Course: Lenvatinib + Pembrolizumab
n=406 participants at risk
Participants with Endometrial cancer (EC) received lenvatinib 20 milligrams (mg) orally, once daily, plus pembrolizumab 200 mg intravenously, every 3 weeks in each 21-day cycle. Participants continued to receive treatment until disease progression, development of unacceptable toxicity, withdrawal of consent, completion of 35 treatments (approximately 2 years) with pembrolizumab, or sponsor termination of the study
|
First Course: TPC Doxorubicin or Paclitaxel
n=388 participants at risk
Participants with EC received either doxorubicin 60 milligrams per square meter (mg/m\^2) intravenously, every 3 weeks, in each 21-day treatment cycle, or paclitaxel 80 mg/m\^2 intravenously, weekly (3 weeks on/1 week off), in each 28-day treatment cycle. Participants continued to receive treatment until a lifetime cumulative dose of 500 mg/m\^2 doxorubicin, a maximum dose of paclitaxel per standard of care, or until disease progression, development of unacceptable toxicity, withdrawal of consent, or sponsor termination of the study.
|
Second Course: Lenvatinib + Pembrolizumab
n=21 participants at risk
Eligible participants who completed the first course of up to 35 administrations of pembrolizumab (\~2 years) and lenvatinib (\~2years) or who had Stable disease (SD) or partial response (PR) or had attained complete response (CR), but experienced radiologic progression of disease (PD) initiated a second course of pembrolizumab and lenvatinib at investigators discretion at the same dose and schedule at lenvatinib 20 mg orally, once daily, plus pembrolizumab 200 mg intravenously, every 3 weeks in each 21-day cycle upto 17 cycles (upto \~1 year)
|
TPC Crossover
n=6 participants at risk
Eligible participants who completed the first course of either doxorubicin 60 milligrams per square meter (mg/m\^2) intravenously, every 3 weeks, in each 21-day treatment cycle, or paclitaxel 80 mg/m\^2 intravenously, weekly (3 weeks on/1 week off), in each 28-day treatment cycle and eligible participants continued to receive treatment until a lifetime cumulative dose of 500 mg/m\^2 doxorubicin, a maximum dose of paclitaxel per standard of care or who had Stable disease (SD) or partial response (PR) or had attained complete response (CR), but experienced radiologic progression of disease (PD) initiated treatment with pembrolizumab and lenvatinib at investigators discretion at the same dose and schedule at lenvatinib 20 mg orally, once daily, plus pembrolizumab 200 mg intravenously, every 3 weeks in each 21-day cycle upto 17 cycles (upto \~1 year)
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
28.3%
115/406 • Number of events 171 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
46.6%
181/388 • Number of events 240 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
4.8%
1/21 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
16.7%
1/6 • Number of events 3 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Blood and lymphatic system disorders
Leukopenia
|
6.9%
28/406 • Number of events 72 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
12.9%
50/388 • Number of events 89 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
4.8%
1/21 • Number of events 3 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
6.4%
26/406 • Number of events 61 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
7.7%
30/388 • Number of events 45 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
9.5%
2/21 • Number of events 5 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
16.7%
1/6 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Blood and lymphatic system disorders
Neutropenia
|
9.4%
38/406 • Number of events 106 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
32.2%
125/388 • Number of events 213 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
4.8%
1/21 • Number of events 3 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
11.3%
46/406 • Number of events 66 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
6.7%
26/388 • Number of events 31 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
33.3%
2/6 • Number of events 3 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Endocrine disorders
Hyperthyroidism
|
11.3%
46/406 • Number of events 50 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
1.0%
4/388 • Number of events 4 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
4.8%
1/21 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
16.7%
1/6 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Endocrine disorders
Hypothyroidism
|
58.6%
238/406 • Number of events 299 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.77%
3/388 • Number of events 3 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
19.0%
4/21 • Number of events 5 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
66.7%
4/6 • Number of events 4 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Gastrointestinal disorders
Abdominal pain
|
23.6%
96/406 • Number of events 141 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
13.4%
52/388 • Number of events 58 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
16.7%
1/6 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
14.0%
57/406 • Number of events 75 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
7.2%
28/388 • Number of events 34 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
14.3%
3/21 • Number of events 3 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
16.7%
1/6 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Gastrointestinal disorders
Constipation
|
28.6%
116/406 • Number of events 142 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
24.5%
95/388 • Number of events 119 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
33.3%
2/6 • Number of events 2 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Gastrointestinal disorders
Diarrhoea
|
54.9%
223/406 • Number of events 686 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
19.6%
76/388 • Number of events 107 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
19.0%
4/21 • Number of events 5 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
50.0%
3/6 • Number of events 6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Gastrointestinal disorders
Dry mouth
|
10.6%
43/406 • Number of events 51 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
3.1%
12/388 • Number of events 16 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Gastrointestinal disorders
Dyspepsia
|
7.6%
31/406 • Number of events 37 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
5.2%
20/388 • Number of events 20 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Gastrointestinal disorders
Gastritis
|
5.7%
23/406 • Number of events 26 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.52%
2/388 • Number of events 2 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
7.6%
31/406 • Number of events 36 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
2.1%
8/388 • Number of events 8 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Gastrointestinal disorders
Haemorrhoids
|
6.9%
28/406 • Number of events 30 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
1.8%
7/388 • Number of events 9 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Gastrointestinal disorders
Nausea
|
52.2%
212/406 • Number of events 352 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
46.1%
179/388 • Number of events 302 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
4.8%
1/21 • Number of events 2 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
33.3%
2/6 • Number of events 3 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Gastrointestinal disorders
Stomatitis
|
19.5%
79/406 • Number of events 97 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
11.9%
46/388 • Number of events 58 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
4.8%
1/21 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Gastrointestinal disorders
Vomiting
|
36.7%
149/406 • Number of events 337 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
20.6%
80/388 • Number of events 122 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
9.5%
2/21 • Number of events 3 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
50.0%
3/6 • Number of events 4 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Infections and infestations
Nasopharyngitis
|
4.2%
17/406 • Number of events 19 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
6.2%
24/388 • Number of events 29 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Infections and infestations
Urinary tract infection
|
26.1%
106/406 • Number of events 171 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
10.1%
39/388 • Number of events 49 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
9.5%
2/21 • Number of events 2 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
33.3%
2/6 • Number of events 2 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Investigations
Alanine aminotransferase increased
|
23.4%
95/406 • Number of events 160 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
5.7%
22/388 • Number of events 28 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
4.8%
1/21 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Investigations
Amylase increased
|
9.1%
37/406 • Number of events 60 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
1.3%
5/388 • Number of events 7 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Investigations
Aspartate aminotransferase increased
|
21.9%
89/406 • Number of events 160 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
4.1%
16/388 • Number of events 17 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
4.8%
1/21 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Investigations
Blood alkaline phosphatase increased
|
13.5%
55/406 • Number of events 81 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
3.9%
15/388 • Number of events 19 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
4.8%
1/21 • Number of events 2 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Investigations
Blood bilirubin increased
|
6.2%
25/406 • Number of events 30 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
1.8%
7/388 • Number of events 10 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Investigations
Blood cholesterol increased
|
9.9%
40/406 • Number of events 68 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
1.8%
7/388 • Number of events 9 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Investigations
Blood creatinine increased
|
12.1%
49/406 • Number of events 70 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
2.6%
10/388 • Number of events 10 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
9.5%
2/21 • Number of events 4 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
16.7%
1/6 • Number of events 2 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
13.3%
54/406 • Number of events 61 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.26%
1/388 • Number of events 2 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
4.8%
1/21 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
16.7%
1/6 • Number of events 3 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Investigations
Lipase increased
|
13.3%
54/406 • Number of events 86 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
2.1%
8/388 • Number of events 9 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
14.3%
3/21 • Number of events 3 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
33.3%
2/6 • Number of events 3 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Investigations
Lymphocyte count decreased
|
4.2%
17/406 • Number of events 28 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
6.2%
24/388 • Number of events 32 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Investigations
Neutrophil count decreased
|
5.7%
23/406 • Number of events 39 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
24.5%
95/388 • Number of events 220 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
16.7%
1/6 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Investigations
Platelet count decreased
|
12.8%
52/406 • Number of events 96 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
5.9%
23/388 • Number of events 28 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
33.3%
2/6 • Number of events 2 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Investigations
Weight decreased
|
36.2%
147/406 • Number of events 169 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
5.9%
23/388 • Number of events 24 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
4.8%
1/21 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
50.0%
3/6 • Number of events 5 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Investigations
White blood cell count decreased
|
5.2%
21/406 • Number of events 29 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
16.2%
63/388 • Number of events 147 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
9.5%
2/21 • Number of events 2 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
16.7%
1/6 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
45.3%
184/406 • Number of events 253 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
21.4%
83/388 • Number of events 99 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
19.0%
4/21 • Number of events 5 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
50.0%
3/6 • Number of events 5 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Metabolism and nutrition disorders
Dehydration
|
5.4%
22/406 • Number of events 29 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
1.8%
7/388 • Number of events 7 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
6.7%
27/406 • Number of events 39 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
1.8%
7/388 • Number of events 11 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
10.3%
42/406 • Number of events 80 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
4.9%
19/388 • Number of events 24 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
4.8%
1/21 • Number of events 2 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
14.0%
57/406 • Number of events 102 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
3.1%
12/388 • Number of events 14 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
16.7%
1/6 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
9.9%
40/406 • Number of events 56 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
4.6%
18/388 • Number of events 20 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
9.5%
2/21 • Number of events 5 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
19.7%
80/406 • Number of events 148 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
7.0%
27/388 • Number of events 30 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
9.5%
2/21 • Number of events 3 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
50.0%
3/6 • Number of events 3 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
9.4%
38/406 • Number of events 49 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
4.1%
16/388 • Number of events 16 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
4.8%
1/21 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
16.7%
1/6 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
33.7%
137/406 • Number of events 209 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
8.0%
31/388 • Number of events 33 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
9.5%
2/21 • Number of events 3 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
16.7%
1/6 • Number of events 2 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
14.8%
60/406 • Number of events 76 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
7.7%
30/388 • Number of events 37 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
23.8%
5/21 • Number of events 5 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
17.7%
72/406 • Number of events 98 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
5.2%
20/388 • Number of events 25 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
33.3%
2/6 • Number of events 2 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
13.5%
55/406 • Number of events 73 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
5.7%
22/388 • Number of events 26 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
4.8%
1/21 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
50.0%
3/6 • Number of events 3 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Nervous system disorders
Dizziness
|
11.3%
46/406 • Number of events 54 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
5.7%
22/388 • Number of events 29 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
9.5%
2/21 • Number of events 3 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Nervous system disorders
Dysgeusia
|
10.3%
42/406 • Number of events 46 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
7.5%
29/388 • Number of events 36 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Nervous system disorders
Headache
|
26.4%
107/406 • Number of events 154 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
9.0%
35/388 • Number of events 36 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Nervous system disorders
Neuropathy peripheral
|
4.7%
19/406 • Number of events 26 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
5.9%
23/388 • Number of events 24 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
16.7%
1/6 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Psychiatric disorders
Insomnia
|
8.6%
35/406 • Number of events 38 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
5.2%
20/388 • Number of events 21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Renal and urinary disorders
Dysuria
|
6.2%
25/406 • Number of events 28 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
2.8%
11/388 • Number of events 13 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
16.7%
1/6 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Renal and urinary disorders
Proteinuria
|
31.5%
128/406 • Number of events 275 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
3.4%
13/388 • Number of events 15 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
19.0%
4/21 • Number of events 10 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
33.3%
2/6 • Number of events 2 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.5%
63/406 • Number of events 78 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
13.1%
51/388 • Number of events 55 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
9.5%
2/21 • Number of events 2 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
23.4%
95/406 • Number of events 114 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.77%
3/388 • Number of events 4 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
66.7%
4/6 • Number of events 4 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
12.3%
50/406 • Number of events 55 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
11.1%
43/388 • Number of events 45 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
14.3%
3/21 • Number of events 3 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
8.4%
34/406 • Number of events 39 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
2.8%
11/388 • Number of events 13 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.2%
25/406 • Number of events 31 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
2.3%
9/388 • Number of events 11 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
4.8%
1/21 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
6.2%
25/406 • Number of events 26 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
30.9%
120/388 • Number of events 120 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
7.9%
32/406 • Number of events 37 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
2.8%
11/388 • Number of events 11 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
21.2%
86/406 • Number of events 98 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.77%
3/388 • Number of events 3 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
50.0%
3/6 • Number of events 3 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
11.3%
46/406 • Number of events 59 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
3.1%
12/388 • Number of events 12 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
9.5%
2/21 • Number of events 2 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
33.3%
2/6 • Number of events 2 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Skin and subcutaneous tissue disorders
Rash
|
16.3%
66/406 • Number of events 91 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
3.4%
13/388 • Number of events 13 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
9.5%
2/21 • Number of events 2 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
16.7%
1/6 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Vascular disorders
Hypertension
|
62.8%
255/406 • Number of events 435 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
5.2%
20/388 • Number of events 28 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
4.8%
1/21 • Number of events 2 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
33.3%
2/6 • Number of events 4 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.49%
2/406 • Number of events 2 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
16.7%
1/6 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Eye disorders
Diplopia
|
0.49%
2/406 • Number of events 2 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
16.7%
1/6 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Eye disorders
Eye pruritus
|
0.74%
3/406 • Number of events 3 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.26%
1/388 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
16.7%
1/6 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
2.2%
9/406 • Number of events 10 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
1.3%
5/388 • Number of events 5 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
4.8%
1/21 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
16.7%
1/6 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.49%
2/406 • Number of events 2 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.77%
3/388 • Number of events 3 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
16.7%
1/6 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Gastrointestinal disorders
Odynophagia
|
0.99%
4/406 • Number of events 6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.77%
3/388 • Number of events 3 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
16.7%
1/6 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Gastrointestinal disorders
Oral pain
|
5.2%
21/406 • Number of events 25 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.77%
3/388 • Number of events 3 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
General disorders
Asthenia
|
24.4%
99/406 • Number of events 129 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
24.0%
93/388 • Number of events 124 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
9.5%
2/21 • Number of events 3 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
General disorders
Chest pain
|
3.4%
14/406 • Number of events 16 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
1.8%
7/388 • Number of events 8 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
4.8%
1/21 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
16.7%
1/6 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
General disorders
Fatigue
|
34.0%
138/406 • Number of events 176 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
27.6%
107/388 • Number of events 146 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
16.7%
1/6 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
General disorders
Malaise
|
6.2%
25/406 • Number of events 35 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
4.9%
19/388 • Number of events 29 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
General disorders
Mucosal inflammation
|
13.3%
54/406 • Number of events 73 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
9.8%
38/388 • Number of events 47 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
16.7%
1/6 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
General disorders
Oedema peripheral
|
14.0%
57/406 • Number of events 76 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
9.3%
36/388 • Number of events 40 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
14.3%
3/21 • Number of events 3 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
General disorders
Pyrexia
|
15.3%
62/406 • Number of events 99 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
6.7%
26/388 • Number of events 29 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
9.5%
2/21 • Number of events 2 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
16.7%
1/6 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Infections and infestations
COVID-19
|
2.7%
11/406 • Number of events 11 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
9.5%
2/21 • Number of events 2 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
33.3%
2/6 • Number of events 2 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Infections and infestations
Cellulitis
|
1.2%
5/406 • Number of events 5 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
1.3%
5/388 • Number of events 5 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
16.7%
1/6 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Infections and infestations
Cystitis
|
5.9%
24/406 • Number of events 29 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
2.1%
8/388 • Number of events 8 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Infections and infestations
Fungal foot infection
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.26%
1/388 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
16.7%
1/6 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Infections and infestations
Influenza
|
2.0%
8/406 • Number of events 8 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
2.1%
8/388 • Number of events 9 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
16.7%
1/6 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Infections and infestations
Oral herpes
|
0.99%
4/406 • Number of events 6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
1.3%
5/388 • Number of events 7 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
16.7%
1/6 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Infections and infestations
Respiratory tract infection
|
0.49%
2/406 • Number of events 2 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
1.0%
4/388 • Number of events 5 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
16.7%
1/6 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Infections and infestations
Tinea infection
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.52%
2/388 • Number of events 2 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
16.7%
1/6 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Infections and infestations
Upper respiratory tract infection
|
6.2%
25/406 • Number of events 27 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
4.4%
17/388 • Number of events 20 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
9.5%
2/21 • Number of events 2 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
16.7%
1/6 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Investigations
Blood calcium decreased
|
0.74%
3/406 • Number of events 3 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.52%
2/388 • Number of events 2 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
16.7%
1/6 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Investigations
Blood chloride decreased
|
0.99%
4/406 • Number of events 4 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.26%
1/388 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
16.7%
1/6 • Number of events 5 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Investigations
Blood creatine phosphokinase increased
|
5.7%
23/406 • Number of events 28 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.52%
2/388 • Number of events 2 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
33.3%
2/6 • Number of events 2 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Investigations
Blood lactate dehydrogenase increased
|
5.4%
22/406 • Number of events 30 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
3.1%
12/388 • Number of events 13 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
4.8%
1/21 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
16.7%
1/6 • Number of events 3 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Investigations
Blood magnesium decreased
|
2.0%
8/406 • Number of events 18 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
1.5%
6/388 • Number of events 7 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
16.7%
1/6 • Number of events 4 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Investigations
Blood phosphorus decreased
|
0.74%
3/406 • Number of events 3 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
16.7%
1/6 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Investigations
Blood sodium decreased
|
1.2%
5/406 • Number of events 9 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
1.0%
4/388 • Number of events 4 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
16.7%
1/6 • Number of events 2 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Investigations
Blood urea increased
|
1.5%
6/406 • Number of events 11 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
1.0%
4/388 • Number of events 6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
16.7%
1/6 • Number of events 2 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Investigations
International normalised ratio increased
|
0.00%
0/406 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
16.7%
1/6 • Number of events 3 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Investigations
White blood cell count increased
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.52%
2/388 • Number of events 3 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
16.7%
1/6 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
5.2%
21/406 • Number of events 24 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.77%
3/388 • Number of events 3 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
4.8%
1/21 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
4.9%
20/406 • Number of events 26 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
1.0%
4/388 • Number of events 4 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
14.3%
3/21 • Number of events 3 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
16.7%
1/6 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
14.8%
60/406 • Number of events 72 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
6.7%
26/388 • Number of events 35 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
9.5%
2/21 • Number of events 4 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
16.7%
1/6 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
4.9%
20/406 • Number of events 29 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
1.8%
7/388 • Number of events 10 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
9.5%
2/21 • Number of events 2 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
16.7%
1/6 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
2.7%
11/406 • Number of events 13 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
2.6%
10/388 • Number of events 10 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
16.7%
1/6 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
4.2%
17/406 • Number of events 23 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
2.1%
8/388 • Number of events 9 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
33.3%
2/6 • Number of events 3 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Nervous system disorders
Taste disorder
|
1.7%
7/406 • Number of events 8 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
1.3%
5/388 • Number of events 6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
16.7%
1/6 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Psychiatric disorders
Anxiety
|
3.4%
14/406 • Number of events 14 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
2.6%
10/388 • Number of events 11 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
16.7%
1/6 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Psychiatric disorders
Initial insomnia
|
0.00%
0/406 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
16.7%
1/6 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Renal and urinary disorders
Leukocyturia
|
0.99%
4/406 • Number of events 9 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.26%
1/388 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
16.7%
1/6 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Reproductive system and breast disorders
Breast pain
|
0.25%
1/406 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
16.7%
1/6 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
5.2%
21/406 • Number of events 26 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
3.1%
12/388 • Number of events 14 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/6 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
1.7%
7/406 • Number of events 7 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
16.7%
1/6 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
1.7%
7/406 • Number of events 7 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
1.0%
4/388 • Number of events 4 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
16.7%
1/6 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.99%
4/406 • Number of events 4 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
1.0%
4/388 • Number of events 4 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
4.8%
1/21 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
16.7%
1/6 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
1.7%
7/406 • Number of events 8 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
1.0%
4/388 • Number of events 4 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
33.3%
2/6 • Number of events 2 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
2.2%
9/406 • Number of events 10 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.26%
1/388 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
16.7%
1/6 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Skin and subcutaneous tissue disorders
Pemphigoid
|
0.49%
2/406 • Number of events 2 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
16.7%
1/6 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.99%
4/406 • Number of events 4 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/388 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
16.7%
1/6 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
|
Vascular disorders
Hot flush
|
2.0%
8/406 • Number of events 9 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
1.8%
7/388 • Number of events 8 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
0.00%
0/21 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
16.7%
1/6 • Number of events 1 • Up to approximately 79 months
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place