Trial Outcomes & Findings for Study of Pembrolizumab (MK-3475) Plus Olaparib Versus Abiraterone Acetate or Enzalutamide in Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-7339-010/KEYLYNK-010) (NCT NCT03834519)
NCT ID: NCT03834519
Last Updated: 2025-05-18
Results Overview
Overall survival (OS) is defined as the time from randomization to death due to any cause. The nonparametric Kaplan-Meier method was used to estimate the survival curves.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
793 participants
Primary outcome timeframe
Up to ~31 months
Results posted on
2025-05-18
Participant Flow
Participants randomized to the next-generation hormonal agent monotherapy (NHA) arm received one of two NHA treatments, per protocol.
Participant milestones
| Measure |
Pembrolizumab + Olaparib
Participants received olaparib 600 mg as two 150 mg oral tablets twice daily (BID) continuously until progression PLUS on Day 1 of each 21-day cycle, pembrolizumab 200 mg by intravenous (IV) infusion for up to 35 cycles (approximately 2 years).
|
Next-generation Hormonal Agent Monotherapy (NHA)
Participants received a single NHA of either abiraterone acetate (participants previously treated with enzalutamide) 1000 mg as two 500 mg or four 250 mg oral tablets once daily (QD) PLUS prednisone or prednisolone 10 mg as one 5 mg tablet BID until progression OR participants received enzalutamide (participants previously treated with abiraterone acetate) 160 mg as four 40 mg oral tablets or capsules OR two 80 mg tablets QD until progression.
|
|---|---|---|
|
Overall Study
STARTED
|
529
|
264
|
|
Overall Study
Treated
|
526
|
256
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
529
|
264
|
Reasons for withdrawal
| Measure |
Pembrolizumab + Olaparib
Participants received olaparib 600 mg as two 150 mg oral tablets twice daily (BID) continuously until progression PLUS on Day 1 of each 21-day cycle, pembrolizumab 200 mg by intravenous (IV) infusion for up to 35 cycles (approximately 2 years).
|
Next-generation Hormonal Agent Monotherapy (NHA)
Participants received a single NHA of either abiraterone acetate (participants previously treated with enzalutamide) 1000 mg as two 500 mg or four 250 mg oral tablets once daily (QD) PLUS prednisone or prednisolone 10 mg as one 5 mg tablet BID until progression OR participants received enzalutamide (participants previously treated with abiraterone acetate) 160 mg as four 40 mg oral tablets or capsules OR two 80 mg tablets QD until progression.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
5
|
8
|
|
Overall Study
Death
|
368
|
174
|
|
Overall Study
Physician Decision
|
5
|
1
|
|
Overall Study
Sponsor decision
|
149
|
80
|
Baseline Characteristics
Study of Pembrolizumab (MK-3475) Plus Olaparib Versus Abiraterone Acetate or Enzalutamide in Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-7339-010/KEYLYNK-010)
Baseline characteristics by cohort
| Measure |
Pembrolizumab + Olaparib
n=529 Participants
Participants received olaparib 600 mg as two 150 mg oral tablets twice daily (BID) continuously until progression PLUS on Day 1 of each 21-day cycle, pembrolizumab 200 mg by intravenous (IV) infusion for up to 35 cycles (approximately 2 years).
|
Next-generation Hormonal Agent Monotherapy (NHA)
n=264 Participants
Participants received a single NHA of either abiraterone acetate (participants previously treated with enzalutamide) 1000 mg as two 500 mg or four 250 mg oral tablets once daily (QD) PLUS prednisone or prednisolone 10 mg as one 5 mg tablet BID until progression OR participants received enzalutamide (participants previously treated with abiraterone acetate) 160 mg as four 40 mg oral tablets or capsules OR two 80 mg tablets QD until progression.
|
Total
n=793 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
69.9 Years
STANDARD_DEVIATION 7.4 • n=99 Participants
|
69.1 Years
STANDARD_DEVIATION 7.3 • n=107 Participants
|
69.6 Years
STANDARD_DEVIATION 7.4 • n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
529 Participants
n=99 Participants
|
264 Participants
n=107 Participants
|
793 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
71 Participants
n=99 Participants
|
32 Participants
n=107 Participants
|
103 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
441 Participants
n=99 Participants
|
219 Participants
n=107 Participants
|
660 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
17 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
102 Participants
n=99 Participants
|
59 Participants
n=107 Participants
|
161 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
419 Participants
n=99 Participants
|
199 Participants
n=107 Participants
|
618 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Measurable Response Evaluation Criteria in Solid Tumors Version 1.1 Disease Status at Baseline
RECIST Measurable: Yes
|
244 Participants
n=99 Participants
|
119 Participants
n=107 Participants
|
363 Participants
n=206 Participants
|
|
Measurable Response Evaluation Criteria in Solid Tumors Version 1.1 Disease Status at Baseline
RECIST Measurable: No
|
285 Participants
n=99 Participants
|
145 Participants
n=107 Participants
|
430 Participants
n=206 Participants
|
|
Prior Use of NHA Treatment
Abiraterone only
|
289 Participants
n=99 Participants
|
143 Participants
n=107 Participants
|
432 Participants
n=206 Participants
|
|
Prior Use of NHA Treatment
Enzalutamide only
|
240 Participants
n=99 Participants
|
120 Participants
n=107 Participants
|
360 Participants
n=206 Participants
|
|
Prior Use of NHA Treatment
Abiraterone and Enzalutamide
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Up to ~31 monthsPopulation: All randomized participants.
Overall survival (OS) is defined as the time from randomization to death due to any cause. The nonparametric Kaplan-Meier method was used to estimate the survival curves.
Outcome measures
| Measure |
Next-generation Hormonal Agent Monotherapy (NHA)
n=264 Participants
Participants received a single NHA of either abiraterone acetate (participants previously treated with enzalutamide) 1000 mg as two 500 mg or four 250 mg oral tablets once daily (QD) PLUS prednisone or prednisolone 10 mg as one 5 mg tablet BID until progression OR participants received enzalutamide (participants previously treated with abiraterone acetate) 160 mg as four 40 mg oral tablets or capsules OR two 80 mg tablets QD until progression.
|
Pembrolizumab + Olaparib
n=529 Participants
Participants received olaparib 600 mg as two 150 mg oral tablets twice daily (BID) continuously until progression PLUS on Day 1 of each 21-day cycle, pembrolizumab 200 mg by intravenous (IV) infusion for up to 35 cycles (approximately 2 years).
|
|---|---|---|
|
Overall Survival (OS)
|
14.6 Months
Interval 12.6 to 17.3
|
15.8 Months
Interval 14.6 to 17.0
|
PRIMARY outcome
Timeframe: Up to ~26 monthsPopulation: All randomized participants.
rPFS is defined as the time from randomization to the first documented progressive disease (PD) per PCWG-modified RECIST 1.1 based on BICR or death due to any cause, whichever occurred first. Per PCWG-modified RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions or ≥2 new bone lesions was also considered PD. PCWG-modified RECIST is similar to RECIST 1.1 with the exception that a confirmation assessment of PD (\>4 weeks after the initial PD) is required for participants who remain on treatment following a documented PD per RECIST 1.1 and PCWG rules include new bone lesions. The rPFS per PCWG-modified RECIST as assessed by BICR for all participants is presented. The nonparametric Kaplan-Meier method was used to estimate the survival curves.
Outcome measures
| Measure |
Next-generation Hormonal Agent Monotherapy (NHA)
n=264 Participants
Participants received a single NHA of either abiraterone acetate (participants previously treated with enzalutamide) 1000 mg as two 500 mg or four 250 mg oral tablets once daily (QD) PLUS prednisone or prednisolone 10 mg as one 5 mg tablet BID until progression OR participants received enzalutamide (participants previously treated with abiraterone acetate) 160 mg as four 40 mg oral tablets or capsules OR two 80 mg tablets QD until progression.
|
Pembrolizumab + Olaparib
n=529 Participants
Participants received olaparib 600 mg as two 150 mg oral tablets twice daily (BID) continuously until progression PLUS on Day 1 of each 21-day cycle, pembrolizumab 200 mg by intravenous (IV) infusion for up to 35 cycles (approximately 2 years).
|
|---|---|---|
|
Radiographic Progression-Free Survival (rPFS)
|
4.2 Months
Interval 4.0 to 6.1
|
4.4 Months
Interval 4.2 to 6.0
|
SECONDARY outcome
Timeframe: Up to ~26 monthsPopulation: All randomized participants.
TFST is the time from randomization to initiation of the first subsequent anticancer therapy defined as the first anti-cancer treatment not part of the study arm for a given participant, or death, whichever occurs first. The nonparametric Kaplan-Meier method was used to estimate the survival curves.
Outcome measures
| Measure |
Next-generation Hormonal Agent Monotherapy (NHA)
n=264 Participants
Participants received a single NHA of either abiraterone acetate (participants previously treated with enzalutamide) 1000 mg as two 500 mg or four 250 mg oral tablets once daily (QD) PLUS prednisone or prednisolone 10 mg as one 5 mg tablet BID until progression OR participants received enzalutamide (participants previously treated with abiraterone acetate) 160 mg as four 40 mg oral tablets or capsules OR two 80 mg tablets QD until progression.
|
Pembrolizumab + Olaparib
n=529 Participants
Participants received olaparib 600 mg as two 150 mg oral tablets twice daily (BID) continuously until progression PLUS on Day 1 of each 21-day cycle, pembrolizumab 200 mg by intravenous (IV) infusion for up to 35 cycles (approximately 2 years).
|
|---|---|---|
|
Time to Initiation of the First Subsequent Anticancer Therapy (TFST)
|
5.7 Months
Interval 5.0 to 7.1
|
7.2 Months
Interval 6.7 to 8.1
|
SECONDARY outcome
Timeframe: Up to ~31 monthsPopulation: All randomized participants who had measurable disease at baseline.
ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions per RECIST 1.1 and no evidence of disease (NED) bone scan) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions per RECIST 1.1 and Non-PD, non-evaluable (NE), or NED bone scan or CR with non-PD or NE bone scan.) The percentage of participants who experienced CR or PR as assessed by BICR is presented.
Outcome measures
| Measure |
Next-generation Hormonal Agent Monotherapy (NHA)
n=119 Participants
Participants received a single NHA of either abiraterone acetate (participants previously treated with enzalutamide) 1000 mg as two 500 mg or four 250 mg oral tablets once daily (QD) PLUS prednisone or prednisolone 10 mg as one 5 mg tablet BID until progression OR participants received enzalutamide (participants previously treated with abiraterone acetate) 160 mg as four 40 mg oral tablets or capsules OR two 80 mg tablets QD until progression.
|
Pembrolizumab + Olaparib
n=244 Participants
Participants received olaparib 600 mg as two 150 mg oral tablets twice daily (BID) continuously until progression PLUS on Day 1 of each 21-day cycle, pembrolizumab 200 mg by intravenous (IV) infusion for up to 35 cycles (approximately 2 years).
|
|---|---|---|
|
Objective Response Rate (ORR)
|
5.9 Percentage of Participants
Interval 2.4 to 11.7
|
16.8 Percentage of Participants
Interval 12.3 to 22.1
|
SECONDARY outcome
Timeframe: Up to ~26 monthsPopulation: All randomized participants who experience a confirmed CR or PR and had measurable disease at baseline.
DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per PCWG-modified RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of ≥ 2 new bone lesions is also considered PD. DOR as assessed by BICR is presented.
Outcome measures
| Measure |
Next-generation Hormonal Agent Monotherapy (NHA)
n=7 Participants
Participants received a single NHA of either abiraterone acetate (participants previously treated with enzalutamide) 1000 mg as two 500 mg or four 250 mg oral tablets once daily (QD) PLUS prednisone or prednisolone 10 mg as one 5 mg tablet BID until progression OR participants received enzalutamide (participants previously treated with abiraterone acetate) 160 mg as four 40 mg oral tablets or capsules OR two 80 mg tablets QD until progression.
|
Pembrolizumab + Olaparib
n=41 Participants
Participants received olaparib 600 mg as two 150 mg oral tablets twice daily (BID) continuously until progression PLUS on Day 1 of each 21-day cycle, pembrolizumab 200 mg by intravenous (IV) infusion for up to 35 cycles (approximately 2 years).
|
|---|---|---|
|
Duration of Response (DOR)
|
8.5 Months
Interval 5.2 to
NA = Upper limit not reached at time of data cut-off due to insufficient number of responding participants with relapse.
|
8.1 Months
Interval 6.2 to 14.1
|
SECONDARY outcome
Timeframe: Up to ~31 monthsPopulation: All randomized participants.
Time to PSA progression is defined as the time from randomization to PSA progression. PSA progression date is defined as the date of: 1\) ≥25% increase and ≥2 ng/mL above the nadir, confirmed by a second value ≥3 weeks later if there is PSA decline from baseline, OR 2) ≥25% increase and ≥2 ng/mL increase from baseline beyond 12 weeks if there is no PSA decline from baseline. The nonparametric Kaplan-Meier method was used to estimate the survival curves.
Outcome measures
| Measure |
Next-generation Hormonal Agent Monotherapy (NHA)
n=264 Participants
Participants received a single NHA of either abiraterone acetate (participants previously treated with enzalutamide) 1000 mg as two 500 mg or four 250 mg oral tablets once daily (QD) PLUS prednisone or prednisolone 10 mg as one 5 mg tablet BID until progression OR participants received enzalutamide (participants previously treated with abiraterone acetate) 160 mg as four 40 mg oral tablets or capsules OR two 80 mg tablets QD until progression.
|
Pembrolizumab + Olaparib
n=529 Participants
Participants received olaparib 600 mg as two 150 mg oral tablets twice daily (BID) continuously until progression PLUS on Day 1 of each 21-day cycle, pembrolizumab 200 mg by intravenous (IV) infusion for up to 35 cycles (approximately 2 years).
|
|---|---|---|
|
Time to Prostate-Specific Antigen (PSA) Progression
|
3.5 Months
Interval 3.2 to 4.3
|
3.3 Months
Interval 3.0 to 3.5
|
SECONDARY outcome
Timeframe: Up to ~31 monthsPopulation: All randomized participants.
SSRE is defined as the time from randomization to the first symptomatic skeletal-related event, defined as whichever occurs first: * First use of external-beam radiation therapy (EBRT) to prevent or relieve skeletal symptoms; * Occurrence of new symptomatic pathologic bone fracture (vertebral or nonvertebral); * Occurrence of spinal cord compression; or * Tumor-related orthopedic surgical intervention
Outcome measures
| Measure |
Next-generation Hormonal Agent Monotherapy (NHA)
n=264 Participants
Participants received a single NHA of either abiraterone acetate (participants previously treated with enzalutamide) 1000 mg as two 500 mg or four 250 mg oral tablets once daily (QD) PLUS prednisone or prednisolone 10 mg as one 5 mg tablet BID until progression OR participants received enzalutamide (participants previously treated with abiraterone acetate) 160 mg as four 40 mg oral tablets or capsules OR two 80 mg tablets QD until progression.
|
Pembrolizumab + Olaparib
n=529 Participants
Participants received olaparib 600 mg as two 150 mg oral tablets twice daily (BID) continuously until progression PLUS on Day 1 of each 21-day cycle, pembrolizumab 200 mg by intravenous (IV) infusion for up to 35 cycles (approximately 2 years).
|
|---|---|---|
|
Time to First Symptomatic Skeletal-Related Event (SSRE)
|
NA Months
NA = Lower limit, median, and upper limit were not reached at time of data cut-off due to insufficient number of responding participants with relapse.
|
NA Months
NA = Lower limit, median, and upper limit were not reached at time of data cut-off due to insufficient number of responding participants with relapse.
|
SECONDARY outcome
Timeframe: Up to ~31 monthsPopulation: All randomized participants.
Time to radiographic soft tissue progression is defined as the time from randomization to radiographic soft tissue progression per soft tissue rule of PCWG-modified RECIST 1.1. Progression is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression. Time to radiographic soft tissue progression as assessed by BICR is presented.
Outcome measures
| Measure |
Next-generation Hormonal Agent Monotherapy (NHA)
n=264 Participants
Participants received a single NHA of either abiraterone acetate (participants previously treated with enzalutamide) 1000 mg as two 500 mg or four 250 mg oral tablets once daily (QD) PLUS prednisone or prednisolone 10 mg as one 5 mg tablet BID until progression OR participants received enzalutamide (participants previously treated with abiraterone acetate) 160 mg as four 40 mg oral tablets or capsules OR two 80 mg tablets QD until progression.
|
Pembrolizumab + Olaparib
n=529 Participants
Participants received olaparib 600 mg as two 150 mg oral tablets twice daily (BID) continuously until progression PLUS on Day 1 of each 21-day cycle, pembrolizumab 200 mg by intravenous (IV) infusion for up to 35 cycles (approximately 2 years).
|
|---|---|---|
|
Time to Radiographic Soft Tissue Progression
|
6.4 Months
Interval 6.1 to 10.2
|
10.3 Months
Interval 8.3 to 12.3
|
SECONDARY outcome
Timeframe: Up to ~31 monthsPopulation: All participants who have at least 1 assessment available and have received at least 1 dose of study intervention.
TTPP is defined as the time from randomization to pain progression as determined by Item 3 of the Brief Pain Inventory Short Form (BPI-SF) and by the Analgesic Quantification Algorithm (AQA) score. Pain progression is defined as: 1. For participants who are asymptomatic at baseline, a ≥2-point change from baseline in the average (4-7 days) BPI-SF item 3 score at 2 consecutive visits OR initiation of opioid use for pain 2. For participants who are symptomatic at baseline (average BPI-SF Item 3 score \>0 and/or currently taking opioids), a ≥2-point change from baseline in the average BPI-SF Item 3 score and an average worst pain score ≥4 and no decrease in average opioid use (≥1-point decrease in AQA score from a starting value of 2 or higher) OR any increase in opioid use at 2 consecutive follow-up visits. Participants who had more than 2 consecutive visits that were not evaluable for pain progression were censored at the last evaluable assessment.
Outcome measures
| Measure |
Next-generation Hormonal Agent Monotherapy (NHA)
n=246 Participants
Participants received a single NHA of either abiraterone acetate (participants previously treated with enzalutamide) 1000 mg as two 500 mg or four 250 mg oral tablets once daily (QD) PLUS prednisone or prednisolone 10 mg as one 5 mg tablet BID until progression OR participants received enzalutamide (participants previously treated with abiraterone acetate) 160 mg as four 40 mg oral tablets or capsules OR two 80 mg tablets QD until progression.
|
Pembrolizumab + Olaparib
n=504 Participants
Participants received olaparib 600 mg as two 150 mg oral tablets twice daily (BID) continuously until progression PLUS on Day 1 of each 21-day cycle, pembrolizumab 200 mg by intravenous (IV) infusion for up to 35 cycles (approximately 2 years).
|
|---|---|---|
|
Time to Pain Progression (TTPP)
|
12.0 Months
Interval 10.1 to
NA = Upper limit was not reached at time of data cut-off due to insufficient number of responding participants with relapse.
|
13.5 Months
Interval 9.7 to
NA = Upper limit was not reached at time of data cut-off due to insufficient number of responding participants with relapse.
|
SECONDARY outcome
Timeframe: Up to ~55 monthsPopulation: All randomized participants who received at least 1 dose of study intervention.
An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experienced an adverse event are presented.
Outcome measures
| Measure |
Next-generation Hormonal Agent Monotherapy (NHA)
n=256 Participants
Participants received a single NHA of either abiraterone acetate (participants previously treated with enzalutamide) 1000 mg as two 500 mg or four 250 mg oral tablets once daily (QD) PLUS prednisone or prednisolone 10 mg as one 5 mg tablet BID until progression OR participants received enzalutamide (participants previously treated with abiraterone acetate) 160 mg as four 40 mg oral tablets or capsules OR two 80 mg tablets QD until progression.
|
Pembrolizumab + Olaparib
n=526 Participants
Participants received olaparib 600 mg as two 150 mg oral tablets twice daily (BID) continuously until progression PLUS on Day 1 of each 21-day cycle, pembrolizumab 200 mg by intravenous (IV) infusion for up to 35 cycles (approximately 2 years).
|
|---|---|---|
|
Number of Participants Who Experience an Adverse Event (AE)
|
238 Participants
|
518 Participants
|
SECONDARY outcome
Timeframe: Up to ~1461 DaysPopulation: All randomized participants who received at least 1 dose of study intervention.
An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study treatment due to an AE are presented.
Outcome measures
| Measure |
Next-generation Hormonal Agent Monotherapy (NHA)
n=256 Participants
Participants received a single NHA of either abiraterone acetate (participants previously treated with enzalutamide) 1000 mg as two 500 mg or four 250 mg oral tablets once daily (QD) PLUS prednisone or prednisolone 10 mg as one 5 mg tablet BID until progression OR participants received enzalutamide (participants previously treated with abiraterone acetate) 160 mg as four 40 mg oral tablets or capsules OR two 80 mg tablets QD until progression.
|
Pembrolizumab + Olaparib
n=526 Participants
Participants received olaparib 600 mg as two 150 mg oral tablets twice daily (BID) continuously until progression PLUS on Day 1 of each 21-day cycle, pembrolizumab 200 mg by intravenous (IV) infusion for up to 35 cycles (approximately 2 years).
|
|---|---|---|
|
Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)
|
11 Participants
|
90 Participants
|
Adverse Events
Pembrolizumab + Olaparib
Serious events: 179 serious events
Other events: 495 other events
Deaths: 372 deaths
Next-generation Hormonal Agent Monotherapy (NHA)
Serious events: 59 serious events
Other events: 215 other events
Deaths: 178 deaths
Serious adverse events
| Measure |
Pembrolizumab + Olaparib
n=526 participants at risk
Participants received olaparib 600 mg as two 150 mg oral tablets twice daily (BID) continuously until progression PLUS on Day 1 of each 21-day cycle, pembrolizumab 200 mg by intravenous (IV) infusion for up to 35 cycles (approximately 2 years).
|
Next-generation Hormonal Agent Monotherapy (NHA)
n=256 participants at risk
Participants received a single NHA of either abiraterone acetate (participants previously treated with enzalutamide) 1000 mg as two 500 mg or four 250 mg oral tablets once daily (QD) PLUS prednisone or prednisolone 10 mg as one 5 mg tablet BID until progression OR participants received enzalutamide (participants previously treated with abiraterone acetate) 160 mg as four 40 mg oral tablets or capsules OR two 80 mg tablets QD until progression.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
3.8%
20/526 • Number of events 22 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
1.2%
3/256 • Number of events 3 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Blood and lymphatic system disorders
Anaemia of malignant disease
|
0.19%
1/526 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.00%
0/256 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.19%
1/526 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.00%
0/256 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.19%
1/526 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.00%
0/256 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.57%
3/526 • Number of events 3 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.00%
0/256 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Cardiac disorders
Acute myocardial infarction
|
0.76%
4/526 • Number of events 4 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.00%
0/256 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Cardiac disorders
Atrial fibrillation
|
0.38%
2/526 • Number of events 4 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.00%
0/256 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Cardiac disorders
Cardiac failure
|
0.76%
4/526 • Number of events 4 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.39%
1/256 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Cardiac disorders
Cardiac failure chronic
|
0.19%
1/526 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.00%
0/256 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Cardiac disorders
Cardiac failure congestive
|
0.38%
2/526 • Number of events 2 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.00%
0/256 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.19%
1/526 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.39%
1/256 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Cardiac disorders
Cardiogenic shock
|
0.19%
1/526 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.00%
0/256 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Cardiac disorders
Coronary artery disease
|
0.19%
1/526 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.00%
0/256 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Cardiac disorders
Coronary artery occlusion
|
0.00%
0/526 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.39%
1/256 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Cardiac disorders
Coronary artery stenosis
|
0.19%
1/526 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.00%
0/256 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Cardiac disorders
Myocardial infarction
|
0.76%
4/526 • Number of events 4 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.00%
0/256 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Cardiac disorders
Myocarditis
|
0.19%
1/526 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.00%
0/256 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/526 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.39%
1/256 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Endocrine disorders
Adrenal insufficiency
|
1.7%
9/526 • Number of events 9 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.39%
1/256 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Endocrine disorders
Hypothyroidism
|
0.19%
1/526 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.00%
0/256 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Eye disorders
Diplopia
|
0.19%
1/526 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.00%
0/256 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/526 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.39%
1/256 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Gastrointestinal disorders
Colitis
|
0.76%
4/526 • Number of events 4 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.00%
0/256 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Gastrointestinal disorders
Diarrhoea
|
0.76%
4/526 • Number of events 4 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.00%
0/256 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Gastrointestinal disorders
Dysphagia
|
0.19%
1/526 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.00%
0/256 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Gastrointestinal disorders
Enteritis
|
0.19%
1/526 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.00%
0/256 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.19%
1/526 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.00%
0/256 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.19%
1/526 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.00%
0/256 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.19%
1/526 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.00%
0/256 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Gastrointestinal disorders
Haematemesis
|
0.19%
1/526 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.00%
0/256 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.19%
1/526 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.00%
0/256 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Gastrointestinal disorders
Mechanical ileus
|
0.19%
1/526 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.00%
0/256 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Gastrointestinal disorders
Melaena
|
0.19%
1/526 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.00%
0/256 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Gastrointestinal disorders
Nausea
|
0.38%
2/526 • Number of events 2 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.00%
0/256 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Gastrointestinal disorders
Neutropenic colitis
|
0.19%
1/526 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.00%
0/256 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Gastrointestinal disorders
Oesophageal haemorrhage
|
0.19%
1/526 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.00%
0/256 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Gastrointestinal disorders
Pneumoperitoneum
|
0.19%
1/526 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.00%
0/256 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.38%
2/526 • Number of events 2 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.00%
0/256 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.19%
1/526 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.00%
0/256 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Gastrointestinal disorders
Subileus
|
0.19%
1/526 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.00%
0/256 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Gastrointestinal disorders
Vomiting
|
0.38%
2/526 • Number of events 2 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.00%
0/256 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
General disorders
Asthenia
|
0.19%
1/526 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.00%
0/256 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
General disorders
Death
|
0.95%
5/526 • Number of events 5 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.78%
2/256 • Number of events 2 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
General disorders
Fatigue
|
0.38%
2/526 • Number of events 2 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.39%
1/256 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
General disorders
General physical health deterioration
|
0.76%
4/526 • Number of events 4 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.00%
0/256 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
General disorders
Malaise
|
0.00%
0/526 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.39%
1/256 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.19%
1/526 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.39%
1/256 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
General disorders
Pain
|
0.19%
1/526 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.78%
2/256 • Number of events 2 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
General disorders
Pyrexia
|
0.76%
4/526 • Number of events 4 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.39%
1/256 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
General disorders
Systemic inflammatory response syndrome
|
0.19%
1/526 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.00%
0/256 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Hepatobiliary disorders
Autoimmune hepatitis
|
0.19%
1/526 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.00%
0/256 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/526 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.39%
1/256 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Hepatobiliary disorders
Gallbladder disorder
|
0.19%
1/526 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.00%
0/256 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.19%
1/526 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.00%
0/256 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Hepatobiliary disorders
Hepatitis
|
0.19%
1/526 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.00%
0/256 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.19%
1/526 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.00%
0/256 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Hepatobiliary disorders
Immune-mediated hepatitis
|
0.19%
1/526 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.00%
0/256 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Immune system disorders
Anaphylactic reaction
|
0.38%
2/526 • Number of events 2 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.00%
0/256 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Immune system disorders
Cytokine release syndrome
|
0.19%
1/526 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.00%
0/256 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Infections and infestations
Appendicitis
|
0.19%
1/526 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.00%
0/256 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Infections and infestations
Atypical pneumonia
|
0.19%
1/526 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.00%
0/256 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Infections and infestations
Bacteraemia
|
0.19%
1/526 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.39%
1/256 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Infections and infestations
COVID-19
|
1.1%
6/526 • Number of events 6 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.39%
1/256 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Infections and infestations
COVID-19 pneumonia
|
0.76%
4/526 • Number of events 4 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.78%
2/256 • Number of events 2 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Infections and infestations
Clostridium difficile colitis
|
0.19%
1/526 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.00%
0/256 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Infections and infestations
Dengue fever
|
0.19%
1/526 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.00%
0/256 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Infections and infestations
Device related infection
|
0.19%
1/526 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.00%
0/256 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Infections and infestations
Encephalitis
|
0.19%
1/526 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.00%
0/256 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Infections and infestations
Erysipelas
|
0.19%
1/526 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.00%
0/256 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Infections and infestations
Herpes zoster
|
0.19%
1/526 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.00%
0/256 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Infections and infestations
Infective spondylitis
|
0.19%
1/526 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.00%
0/256 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Infections and infestations
Kidney infection
|
0.19%
1/526 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.00%
0/256 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Infections and infestations
Oral candidiasis
|
0.19%
1/526 • Number of events 2 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.00%
0/256 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Infections and infestations
Periodontitis
|
0.19%
1/526 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.00%
0/256 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.19%
1/526 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.00%
0/256 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Infections and infestations
Pneumonia
|
2.9%
15/526 • Number of events 15 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.78%
2/256 • Number of events 2 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Infections and infestations
Pneumonia aspiration
|
0.38%
2/526 • Number of events 2 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.00%
0/256 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Infections and infestations
Pneumonia bacterial
|
0.19%
1/526 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.00%
0/256 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Infections and infestations
Progressive multifocal leukoencephalopathy
|
0.19%
1/526 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.00%
0/256 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Infections and infestations
Prostatitis Escherichia coli
|
0.00%
0/526 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.39%
1/256 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Infections and infestations
Pyelonephritis
|
0.57%
3/526 • Number of events 3 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
1.2%
3/256 • Number of events 3 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Infections and infestations
Sepsis
|
0.76%
4/526 • Number of events 4 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.39%
1/256 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Infections and infestations
Septic shock
|
0.95%
5/526 • Number of events 5 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.00%
0/256 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Infections and infestations
Streptococcal bacteraemia
|
0.19%
1/526 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.00%
0/256 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Infections and infestations
Urinary tract infection
|
2.1%
11/526 • Number of events 12 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
1.6%
4/256 • Number of events 4 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Infections and infestations
Urosepsis
|
0.19%
1/526 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.78%
2/256 • Number of events 2 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.19%
1/526 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.00%
0/256 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Injury, poisoning and procedural complications
Contusion
|
0.19%
1/526 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.00%
0/256 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.19%
1/526 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.00%
0/256 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Injury, poisoning and procedural complications
Fall
|
0.19%
1/526 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.00%
0/256 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.19%
1/526 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.00%
0/256 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.38%
2/526 • Number of events 2 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.39%
1/256 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Injury, poisoning and procedural complications
Fracture
|
0.19%
1/526 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.39%
1/256 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Injury, poisoning and procedural complications
Gastroenteritis radiation
|
0.19%
1/526 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.00%
0/256 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.19%
1/526 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.00%
0/256 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Injury, poisoning and procedural complications
Ilium fracture
|
0.00%
0/526 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.39%
1/256 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.19%
1/526 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.00%
0/256 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Injury, poisoning and procedural complications
Post-traumatic pain
|
0.19%
1/526 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.00%
0/256 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Injury, poisoning and procedural complications
Radiation proctitis
|
0.00%
0/526 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.39%
1/256 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/526 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.39%
1/256 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.19%
1/526 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.39%
1/256 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.38%
2/526 • Number of events 2 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.00%
0/256 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.19%
1/526 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.00%
0/256 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.00%
0/526 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.39%
1/256 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.19%
1/526 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.00%
0/256 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Investigations
Aspartate aminotransferase increased
|
0.19%
1/526 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.00%
0/256 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Investigations
Blood alkaline phosphatase increased
|
0.19%
1/526 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.00%
0/256 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/526 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.39%
1/256 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Investigations
Blood creatinine increased
|
0.19%
1/526 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.00%
0/256 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/526 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.39%
1/256 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Investigations
SARS-CoV-2 test positive
|
0.19%
1/526 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.00%
0/256 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.19%
1/526 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.00%
0/256 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Metabolism and nutrition disorders
Dehydration
|
0.57%
3/526 • Number of events 3 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.00%
0/256 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.19%
1/526 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.00%
0/256 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.19%
1/526 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.00%
0/256 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Metabolism and nutrition disorders
Hyperglycaemic hyperosmolar nonketotic syndrome
|
0.19%
1/526 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.00%
0/256 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.57%
3/526 • Number of events 3 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.00%
0/256 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.19%
1/526 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
1.2%
3/256 • Number of events 3 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Metabolism and nutrition disorders
Type 1 diabetes mellitus
|
0.00%
0/526 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.39%
1/256 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.3%
7/526 • Number of events 7 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.78%
2/256 • Number of events 2 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.57%
3/526 • Number of events 3 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.00%
0/256 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Musculoskeletal and connective tissue disorders
Chondrocalcinosis
|
0.19%
1/526 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.00%
0/256 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/526 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.39%
1/256 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/526 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.39%
1/256 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.19%
1/526 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.00%
0/256 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of jaw
|
0.19%
1/526 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.78%
2/256 • Number of events 2 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/526 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.39%
1/256 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Musculoskeletal and connective tissue disorders
Polyarthritis
|
0.19%
1/526 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.00%
0/256 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Musculoskeletal and connective tissue disorders
Polymyalgia rheumatica
|
0.19%
1/526 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.00%
0/256 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/526 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.39%
1/256 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Musculoskeletal and connective tissue disorders
Spinal stenosis
|
0.19%
1/526 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.00%
0/256 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/526 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.39%
1/256 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.19%
1/526 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.39%
1/256 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.00%
0/526 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.39%
1/256 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.19%
1/526 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.00%
0/256 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.19%
1/526 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.00%
0/256 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.19%
1/526 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.39%
1/256 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.19%
1/526 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.00%
0/256 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Nervous system disorders
Cerebral ischaemia
|
0.19%
1/526 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.00%
0/256 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Nervous system disorders
Cerebrovascular accident
|
0.57%
3/526 • Number of events 3 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.39%
1/256 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Nervous system disorders
Depressed level of consciousness
|
0.19%
1/526 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.00%
0/256 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Nervous system disorders
Ischaemic stroke
|
0.19%
1/526 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.00%
0/256 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Nervous system disorders
Paraparesis
|
0.00%
0/526 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.39%
1/256 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Nervous system disorders
Paraplegia
|
0.19%
1/526 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.00%
0/256 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Nervous system disorders
Presyncope
|
0.19%
1/526 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.39%
1/256 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Nervous system disorders
Sciatica
|
0.19%
1/526 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.39%
1/256 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Nervous system disorders
Seizure
|
0.19%
1/526 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.00%
0/256 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Nervous system disorders
Spinal cord compression
|
0.95%
5/526 • Number of events 5 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.00%
0/256 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Nervous system disorders
Syncope
|
0.19%
1/526 • Number of events 2 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.00%
0/256 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Nervous system disorders
Transient ischaemic attack
|
0.19%
1/526 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.39%
1/256 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Psychiatric disorders
Confusional state
|
0.38%
2/526 • Number of events 2 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.39%
1/256 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Renal and urinary disorders
Acute kidney injury
|
0.57%
3/526 • Number of events 3 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.39%
1/256 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Renal and urinary disorders
Haematuria
|
0.57%
3/526 • Number of events 4 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
1.6%
4/256 • Number of events 4 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Renal and urinary disorders
Haemorrhage urinary tract
|
0.19%
1/526 • Number of events 3 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.00%
0/256 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Renal and urinary disorders
Hydronephrosis
|
0.19%
1/526 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.39%
1/256 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.19%
1/526 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.00%
0/256 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Renal and urinary disorders
Postrenal failure
|
0.19%
1/526 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.00%
0/256 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Renal and urinary disorders
Pyelocaliectasis
|
0.00%
0/526 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.39%
1/256 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/526 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.39%
1/256 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Renal and urinary disorders
Renal failure
|
0.38%
2/526 • Number of events 2 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.00%
0/256 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Renal and urinary disorders
Renal impairment
|
0.38%
2/526 • Number of events 2 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.00%
0/256 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Renal and urinary disorders
Ureteric stenosis
|
0.19%
1/526 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.00%
0/256 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.19%
1/526 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.00%
0/256 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Renal and urinary disorders
Urinary retention
|
0.76%
4/526 • Number of events 5 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.78%
2/256 • Number of events 3 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.95%
5/526 • Number of events 5 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.39%
1/256 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Respiratory, thoracic and mediastinal disorders
Immune-mediated lung disease
|
0.19%
1/526 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.00%
0/256 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.19%
1/526 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.00%
0/256 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.19%
1/526 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.00%
0/256 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumomediastinum
|
0.19%
1/526 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.00%
0/256 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.19%
1/526 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.00%
0/256 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.57%
3/526 • Number of events 3 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.00%
0/256 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.19%
1/526 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.00%
0/256 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.19%
1/526 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.00%
0/256 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Skin and subcutaneous tissue disorders
Toxic epidermal necrolysis
|
0.00%
0/526 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.39%
1/256 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Skin and subcutaneous tissue disorders
Toxic skin eruption
|
0.19%
1/526 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.00%
0/256 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Vascular disorders
Aortic aneurysm
|
0.19%
1/526 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.00%
0/256 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Vascular disorders
Deep vein thrombosis
|
0.19%
1/526 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.00%
0/256 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Vascular disorders
Embolism
|
0.38%
2/526 • Number of events 2 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.00%
0/256 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Vascular disorders
Hypertension
|
0.19%
1/526 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.00%
0/256 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Vascular disorders
Hypertensive crisis
|
0.19%
1/526 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.00%
0/256 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Vascular disorders
Hypotension
|
0.19%
1/526 • Number of events 1 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
0.00%
0/256 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
Other adverse events
| Measure |
Pembrolizumab + Olaparib
n=526 participants at risk
Participants received olaparib 600 mg as two 150 mg oral tablets twice daily (BID) continuously until progression PLUS on Day 1 of each 21-day cycle, pembrolizumab 200 mg by intravenous (IV) infusion for up to 35 cycles (approximately 2 years).
|
Next-generation Hormonal Agent Monotherapy (NHA)
n=256 participants at risk
Participants received a single NHA of either abiraterone acetate (participants previously treated with enzalutamide) 1000 mg as two 500 mg or four 250 mg oral tablets once daily (QD) PLUS prednisone or prednisolone 10 mg as one 5 mg tablet BID until progression OR participants received enzalutamide (participants previously treated with abiraterone acetate) 160 mg as four 40 mg oral tablets or capsules OR two 80 mg tablets QD until progression.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
51.7%
272/526 • Number of events 327 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
14.1%
36/256 • Number of events 38 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Endocrine disorders
Hypothyroidism
|
10.3%
54/526 • Number of events 55 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
1.6%
4/256 • Number of events 4 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Gastrointestinal disorders
Constipation
|
20.5%
108/526 • Number of events 124 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
17.2%
44/256 • Number of events 47 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Gastrointestinal disorders
Diarrhoea
|
19.6%
103/526 • Number of events 135 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
8.2%
21/256 • Number of events 25 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Gastrointestinal disorders
Nausea
|
42.4%
223/526 • Number of events 280 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
18.4%
47/256 • Number of events 51 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Gastrointestinal disorders
Vomiting
|
17.5%
92/526 • Number of events 149 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
7.0%
18/256 • Number of events 20 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
General disorders
Asthenia
|
18.1%
95/526 • Number of events 109 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
10.5%
27/256 • Number of events 29 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
General disorders
Fatigue
|
35.7%
188/526 • Number of events 200 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
25.8%
66/256 • Number of events 67 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
General disorders
Oedema peripheral
|
9.1%
48/526 • Number of events 51 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
5.5%
14/256 • Number of events 16 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
General disorders
Pyrexia
|
9.9%
52/526 • Number of events 61 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
2.7%
7/256 • Number of events 8 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Infections and infestations
Urinary tract infection
|
4.9%
26/526 • Number of events 33 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
5.1%
13/256 • Number of events 16 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Investigations
Alanine aminotransferase increased
|
5.5%
29/526 • Number of events 30 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
2.7%
7/256 • Number of events 7 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Investigations
Aspartate aminotransferase increased
|
7.6%
40/526 • Number of events 49 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
3.9%
10/256 • Number of events 10 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Investigations
Blood alkaline phosphatase increased
|
6.7%
35/526 • Number of events 38 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
9.8%
25/256 • Number of events 28 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Investigations
Blood creatinine increased
|
8.9%
47/526 • Number of events 57 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
2.3%
6/256 • Number of events 6 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Investigations
Weight decreased
|
13.5%
71/526 • Number of events 74 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
5.9%
15/256 • Number of events 15 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
29.5%
155/526 • Number of events 178 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
18.0%
46/256 • Number of events 53 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
18.8%
99/526 • Number of events 122 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
14.5%
37/256 • Number of events 46 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.2%
85/526 • Number of events 95 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
17.6%
45/256 • Number of events 52 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
6.7%
35/526 • Number of events 43 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
10.2%
26/256 • Number of events 27 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.3%
33/526 • Number of events 36 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
3.1%
8/256 • Number of events 10 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.8%
36/526 • Number of events 40 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
9.0%
23/256 • Number of events 31 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Nervous system disorders
Dizziness
|
8.4%
44/526 • Number of events 53 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
3.5%
9/256 • Number of events 9 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Nervous system disorders
Dysgeusia
|
5.9%
31/526 • Number of events 32 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
1.2%
3/256 • Number of events 3 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Nervous system disorders
Headache
|
5.5%
29/526 • Number of events 36 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
5.1%
13/256 • Number of events 19 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Psychiatric disorders
Insomnia
|
4.6%
24/526 • Number of events 26 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
5.1%
13/256 • Number of events 14 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Renal and urinary disorders
Haematuria
|
5.1%
27/526 • Number of events 35 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
4.3%
11/256 • Number of events 14 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.5%
29/526 • Number of events 34 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
2.7%
7/256 • Number of events 7 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
8.7%
46/526 • Number of events 57 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
3.5%
9/256 • Number of events 10 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.4%
39/526 • Number of events 44 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
2.3%
6/256 • Number of events 6 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.0%
37/526 • Number of events 47 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
1.2%
3/256 • Number of events 3 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Vascular disorders
Hot flush
|
2.1%
11/526 • Number of events 11 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
5.9%
15/256 • Number of events 15 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
|
Vascular disorders
Hypertension
|
5.9%
31/526 • Number of events 37 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
12.1%
31/256 • Number of events 32 • For All-Cause Mortality: from allocation up to ~55 months. For AEs from start of treatment up to ~55 months.
All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme LLC
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments. Authorship will be determined by mutual agreement and in line with International Committee of Medical Journal Editors authorship requirements.
- Publication restrictions are in place
Restriction type: OTHER