Trial Outcomes & Findings for A Study of Apalutamide in Chinese Participants With Non Metastatic Castration Resistant Prostate Cancer (NM-CRPC) (NCT NCT04108208)
NCT ID: NCT04108208
Last Updated: 2025-11-13
Results Overview
Time to prostate specific antigen progression (TTPP) was defined as the time from randomization to the first date of documented PSA progression based on PCWG2 criteria. PCWG2 was defined as the PSA progression as 1) the date that a 25 percent (%) or greater increase and an absolute increase of 2 nanograms per milliliter (ng/mL) or more from the Nadir was documented, which was confirmed by a second value obtained 3 or more weeks later. 2) Where no decline from baseline was documented as a 25% increase from the baseline value along with an increase in absolute value of 2 ng/mL or more after 12 week of treatment. Kaplan-Meier method was used for the analysis.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE4
Target enrollment
75 participants
Primary outcome timeframe
From randomization until first documented PSA progression (up to 3 years 3 months)
Results posted on
2025-11-13
Participant Flow
Results are currently reported till primary completion date (01 Jun 2023). Post completing end of treatment (EoT, 30 days after last dose of study treatment) visit, participants entered post-treatment followup phase and remained in study until death, recording of development of symptomatic progression, initiation of any new systemic anticancer therapies, withdrawal of consent or study termination. Follow-up phase is still ongoing and thus remaining results will be posted upon study completion.
Participant milestones
| Measure |
Placebo Plus Androgen-deprivation Therapy (ADT)
Participants received placebo matching to apalutamide tablets orally once daily along with ADT of Cycle 1 Day 1 until disease progression, unacceptable toxicity, withdrawal of consent, death or termination of the study. Each treatment cycle was of 28 days. Participants who did not have distant metastasis were switched to receive apalutamide + ADT from Cycle 6 Day 1 and those who had prostate-specific antigen (PSA) prior to completion of first 5 cycles crossed over to receive apalutamide + ADT at the time of PSA progression. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, death or termination of the study by the sponsor.
|
Apalutamide 240 mg Plus ADT
Participants received apalutamide 240 milligrams (mg) tablets (4 tablets of 60 mg) orally once daily along with ADT from Cycle 1 Day 1 until disease progression, unacceptable toxicity, withdrawal of consent, death or termination of the study. Each treatment cycle was of 28 days.
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
50
|
|
Overall Study
Crossed-over to Apalutamide
|
22
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
25
|
50
|
Reasons for withdrawal
| Measure |
Placebo Plus Androgen-deprivation Therapy (ADT)
Participants received placebo matching to apalutamide tablets orally once daily along with ADT of Cycle 1 Day 1 until disease progression, unacceptable toxicity, withdrawal of consent, death or termination of the study. Each treatment cycle was of 28 days. Participants who did not have distant metastasis were switched to receive apalutamide + ADT from Cycle 6 Day 1 and those who had prostate-specific antigen (PSA) prior to completion of first 5 cycles crossed over to receive apalutamide + ADT at the time of PSA progression. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, death or termination of the study by the sponsor.
|
Apalutamide 240 mg Plus ADT
Participants received apalutamide 240 milligrams (mg) tablets (4 tablets of 60 mg) orally once daily along with ADT from Cycle 1 Day 1 until disease progression, unacceptable toxicity, withdrawal of consent, death or termination of the study. Each treatment cycle was of 28 days.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
6
|
|
Overall Study
other-ongoing
|
20
|
40
|
|
Overall Study
Death
|
1
|
4
|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
Baseline Characteristics
A Study of Apalutamide in Chinese Participants With Non Metastatic Castration Resistant Prostate Cancer (NM-CRPC)
Baseline characteristics by cohort
| Measure |
Placebo Plus Androgen-deprivation Therapy (ADT)
n=25 Participants
Participants received placebo matching to apalutamide tablets orally once daily along with ADT of Cycle 1 Day 1 until disease progression, unacceptable toxicity, withdrawal of consent, death or termination of the study. Each treatment cycle was of 28 days. Participants who did not have distant metastasis were switched to receive apalutamide + ADT from Cycle 6 Day 1 and those who had prostate-specific antigen (PSA) prior to completion of first 5 cycles crossed over to receive apalutamide + ADT at the time of PSA progression. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, death or termination of the study by the sponsor.
|
Apalutamide 240 mg Plus ADT
n=50 Participants
Participants received apalutamide 240 milligrams (mg) tablets (4 tablets of 60 mg) orally once daily along with ADT from Cycle 1 Day 1 until disease progression, unacceptable toxicity, withdrawal of consent, death or termination of the study. Each treatment cycle was of 28 days.
|
Total
n=75 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
74.5 Years
STANDARD_DEVIATION 7.82 • n=10 Participants
|
75.1 Years
STANDARD_DEVIATION 7.90 • n=10 Participants
|
74.9 Years
STANDARD_DEVIATION 7.83 • n=20 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=10 Participants
|
50 Participants
n=10 Participants
|
75 Participants
n=20 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Asian
|
25 Participants
n=10 Participants
|
50 Participants
n=10 Participants
|
75 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
|
Region of Enrollment
China
|
25 Participants
n=10 Participants
|
50 Participants
n=10 Participants
|
75 Participants
n=20 Participants
|
PRIMARY outcome
Timeframe: From randomization until first documented PSA progression (up to 3 years 3 months)Population: The Intent-to-Treat (ITT) analysis set included all randomized participants and were classified according to their assigned treatment group, regardless of the actual treatment received.
Time to prostate specific antigen progression (TTPP) was defined as the time from randomization to the first date of documented PSA progression based on PCWG2 criteria. PCWG2 was defined as the PSA progression as 1) the date that a 25 percent (%) or greater increase and an absolute increase of 2 nanograms per milliliter (ng/mL) or more from the Nadir was documented, which was confirmed by a second value obtained 3 or more weeks later. 2) Where no decline from baseline was documented as a 25% increase from the baseline value along with an increase in absolute value of 2 ng/mL or more after 12 week of treatment. Kaplan-Meier method was used for the analysis.
Outcome measures
| Measure |
Placebo Plus Androgen-deprivation Therapy (ADT)
n=25 Participants
Participants received placebo matching to apalutamide tablets orally once daily along with ADT of Cycle 1 Day 1 until disease progression, unacceptable toxicity, withdrawal of consent, death or termination of the study. Each treatment cycle was of 28 days. Participants who did not have distant metastasis were switched to receive apalutamide + ADT from Cycle 6 Day 1 and those who had prostate-specific antigen (PSA) prior to completion of first 5 cycles crossed over to receive apalutamide + ADT at the time of PSA progression. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, death or termination of the study by the sponsor.
|
Apalutamide 240 mg Plus ADT
n=50 Participants
Participants received apalutamide 240 milligrams (mg) tablets (4 tablets of 60 mg) orally once daily along with ADT from Cycle 1 Day 1 until disease progression, unacceptable toxicity, withdrawal of consent, death or termination of the study. Each treatment cycle was of 28 days.
|
|---|---|---|
|
Time to Prostate Specific Antigen (PSA) Progression (TTPP) Based on Prostate Cancer Working Group 2 (PCWG2) Criteria
|
NA Months
Interval 3.55 to
Here, "NA" denotes in the median and upper limit of 95% confidence interval (CI) were not estimable due to insufficient number of participants with events.
|
NA Months
Interval 25.76 to
Here, "NA" denotes in the median and upper limit of 95% CI were not estimable due to insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: Up to 6 years 4 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 6 years 4 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 6 years 4 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Presdose: Day 1 of Cycles 1, 2, 3, and 6; 2 hours postdose: Day 1 of Cycles 1 and 3Outcome measures
Outcome data not reported
Adverse Events
Placebo Plus Androgen-deprivation Therapy (ADT)
Serious events: 4 serious events
Other events: 11 other events
Deaths: 1 deaths
Apalutamide 240 mg Plus ADT
Serious events: 20 serious events
Other events: 47 other events
Deaths: 4 deaths
Placebo + ADT to Apalutamide + ADT
Serious events: 5 serious events
Other events: 21 other events
Deaths: 0 deaths
All Participants: Apalutamide 240 mg Plus ADT
Serious events: 25 serious events
Other events: 68 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Placebo Plus Androgen-deprivation Therapy (ADT)
n=25 participants at risk
Participants received placebo matching to apalutamide tablets orally once daily along with ADT of Cycle 1 Day 1 until disease progression, unacceptable toxicity, withdrawal of consent, death or termination of the study. Each treatment cycle was of 28 days. Participants who did not have distant metastasis were switched to receive apalutamide + ADT from Cycle 6 Day 1 and those who had prostate-specific antigen (PSA) prior to completion of first 5 cycles crossed over to receive apalutamide + ADT at the time of PSA progression. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, death or termination of the study by the sponsor.
|
Apalutamide 240 mg Plus ADT
n=50 participants at risk
Participants received apalutamide 240 milligrams (mg) tablets (4 tablets of 60 mg) orally once daily along with ADT from Cycle 1 Day 1 until disease progression, unacceptable toxicity, withdrawal of consent, death or termination of the study. Each treatment cycle was of 28 days.
|
Placebo + ADT to Apalutamide + ADT
n=22 participants at risk
In placebo arm, participants who did not have distant metastasis after completion of 5 cycles of placebo plus ADT treatment and participants who had PSA progression prior to completion of 5 cycles of study treatment were crossed over to apalutamide 240 mg + ADT treatment and were treated until disease progression, unacceptable toxicity, withdrawal of consent, death or termination of the study.
|
All Participants: Apalutamide 240 mg Plus ADT
n=72 participants at risk
All participants who received apalutamide 240 mg in arm 'Apalutamide 240 mg Plus ADT' and arm 'Placebo + ADT to Apalutamide + ADT".
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/25 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
0.00%
0/50 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
4.5%
1/22 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
1.4%
1/72 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
|
Cardiac disorders
Atrioventricular Block Complete
|
0.00%
0/25 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
2.0%
1/50 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
0.00%
0/22 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
1.4%
1/72 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
|
Ear and labyrinth disorders
Mixed Deafness
|
4.0%
1/25 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
0.00%
0/50 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
0.00%
0/22 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
0.00%
0/72 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
|
Gastrointestinal disorders
Gastritis Erosive
|
0.00%
0/25 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
0.00%
0/50 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
4.5%
1/22 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
1.4%
1/72 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
|
Gastrointestinal disorders
Pancreatitis Acute
|
0.00%
0/25 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
2.0%
1/50 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
0.00%
0/22 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
1.4%
1/72 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/25 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
2.0%
1/50 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
0.00%
0/22 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
1.4%
1/72 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
|
Infections and infestations
Covid-19
|
0.00%
0/25 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
4.0%
2/50 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
4.5%
1/22 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
4.2%
3/72 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/25 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
10.0%
5/50 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
0.00%
0/22 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
6.9%
5/72 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
|
Infections and infestations
Sepsis
|
0.00%
0/25 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
0.00%
0/50 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
4.5%
1/22 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
1.4%
1/72 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
|
Injury, poisoning and procedural complications
Femur Fracture
|
0.00%
0/25 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
0.00%
0/50 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
4.5%
1/22 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
1.4%
1/72 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
|
Injury, poisoning and procedural complications
Humerus Fracture
|
0.00%
0/25 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
2.0%
1/50 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
0.00%
0/22 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
1.4%
1/72 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
|
Injury, poisoning and procedural complications
Lower Limb Fracture
|
0.00%
0/25 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
2.0%
1/50 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
0.00%
0/22 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
1.4%
1/72 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
|
Injury, poisoning and procedural complications
Lumbar Vertebral Fracture
|
0.00%
0/25 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
2.0%
1/50 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
0.00%
0/22 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
1.4%
1/72 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
|
Injury, poisoning and procedural complications
Pelvic Fracture
|
0.00%
0/25 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
2.0%
1/50 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
0.00%
0/22 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
1.4%
1/72 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
|
Injury, poisoning and procedural complications
Thoracic Vertebral Fracture
|
0.00%
0/25 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
2.0%
1/50 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
0.00%
0/22 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
1.4%
1/72 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
|
Injury, poisoning and procedural complications
Tibia Fracture
|
0.00%
0/25 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
2.0%
1/50 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
0.00%
0/22 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
1.4%
1/72 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
|
Metabolism and nutrition disorders
Type 2 Diabetes Mellitus
|
0.00%
0/25 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
2.0%
1/50 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
0.00%
0/22 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
1.4%
1/72 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
|
Musculoskeletal and connective tissue disorders
Osteoporotic Fracture
|
0.00%
0/25 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
2.0%
1/50 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
0.00%
0/22 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
1.4%
1/72 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal Stromal Tumour
|
4.0%
1/25 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
0.00%
0/50 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
0.00%
0/22 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
0.00%
0/72 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Neoplasm Malignant
|
0.00%
0/25 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
2.0%
1/50 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
0.00%
0/22 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
1.4%
1/72 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small Cell Lung Cancer
|
0.00%
0/25 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
2.0%
1/50 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
0.00%
0/22 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
1.4%
1/72 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
|
Nervous system disorders
Cerebral Infarction
|
4.0%
1/25 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
0.00%
0/50 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
0.00%
0/22 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
0.00%
0/72 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
|
Nervous system disorders
Hypoxic-Ischaemic Encephalopathy
|
0.00%
0/25 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
2.0%
1/50 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
0.00%
0/22 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
1.4%
1/72 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
|
Psychiatric disorders
Suicide Attempt
|
4.0%
1/25 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
0.00%
0/50 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
0.00%
0/22 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
0.00%
0/72 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
|
Renal and urinary disorders
Calculus Bladder
|
0.00%
0/25 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
4.0%
2/50 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
0.00%
0/22 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
2.8%
2/72 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
|
Skin and subcutaneous tissue disorders
Angiolymphoid Hyperplasia with Eosinophilia
|
0.00%
0/25 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
2.0%
1/50 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
0.00%
0/22 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
1.4%
1/72 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Exfoliative Generalised
|
0.00%
0/25 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
0.00%
0/50 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
4.5%
1/22 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
1.4%
1/72 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
|
Vascular disorders
Hypertension
|
0.00%
0/25 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
2.0%
1/50 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
0.00%
0/22 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
1.4%
1/72 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
Other adverse events
| Measure |
Placebo Plus Androgen-deprivation Therapy (ADT)
n=25 participants at risk
Participants received placebo matching to apalutamide tablets orally once daily along with ADT of Cycle 1 Day 1 until disease progression, unacceptable toxicity, withdrawal of consent, death or termination of the study. Each treatment cycle was of 28 days. Participants who did not have distant metastasis were switched to receive apalutamide + ADT from Cycle 6 Day 1 and those who had prostate-specific antigen (PSA) prior to completion of first 5 cycles crossed over to receive apalutamide + ADT at the time of PSA progression. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, death or termination of the study by the sponsor.
|
Apalutamide 240 mg Plus ADT
n=50 participants at risk
Participants received apalutamide 240 milligrams (mg) tablets (4 tablets of 60 mg) orally once daily along with ADT from Cycle 1 Day 1 until disease progression, unacceptable toxicity, withdrawal of consent, death or termination of the study. Each treatment cycle was of 28 days.
|
Placebo + ADT to Apalutamide + ADT
n=22 participants at risk
In placebo arm, participants who did not have distant metastasis after completion of 5 cycles of placebo plus ADT treatment and participants who had PSA progression prior to completion of 5 cycles of study treatment were crossed over to apalutamide 240 mg + ADT treatment and were treated until disease progression, unacceptable toxicity, withdrawal of consent, death or termination of the study.
|
All Participants: Apalutamide 240 mg Plus ADT
n=72 participants at risk
All participants who received apalutamide 240 mg in arm 'Apalutamide 240 mg Plus ADT' and arm 'Placebo + ADT to Apalutamide + ADT".
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
12.0%
3/25 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
30.0%
15/50 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
22.7%
5/22 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
27.8%
20/72 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/25 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
18.0%
9/50 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
13.6%
3/22 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
16.7%
12/72 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
4.0%
1/25 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
8.0%
4/50 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
4.5%
1/22 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
6.9%
5/72 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/25 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
8.0%
4/50 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
9.1%
2/22 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
8.3%
6/72 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/25 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
6.0%
3/50 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
0.00%
0/22 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
4.2%
3/72 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/25 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
4.0%
2/50 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
9.1%
2/22 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
5.6%
4/72 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
|
General disorders
Fatigue
|
0.00%
0/25 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
6.0%
3/50 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
4.5%
1/22 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
5.6%
4/72 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
|
General disorders
Malaise
|
0.00%
0/25 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
8.0%
4/50 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
0.00%
0/22 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
5.6%
4/72 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
|
General disorders
Oedema Peripheral
|
0.00%
0/25 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
6.0%
3/50 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
0.00%
0/22 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
4.2%
3/72 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
|
General disorders
Pyrexia
|
4.0%
1/25 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
0.00%
0/50 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
18.2%
4/22 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
5.6%
4/72 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
|
Infections and infestations
Covid-19
|
0.00%
0/25 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
12.0%
6/50 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
22.7%
5/22 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
15.3%
11/72 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
|
Infections and infestations
Pneumonia
|
4.0%
1/25 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
8.0%
4/50 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
0.00%
0/22 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
5.6%
4/72 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
|
Infections and infestations
Suspected Covid-19
|
0.00%
0/25 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
0.00%
0/50 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
9.1%
2/22 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
2.8%
2/72 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/25 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
6.0%
3/50 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
0.00%
0/22 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
4.2%
3/72 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
|
Injury, poisoning and procedural complications
Rib Fracture
|
4.0%
1/25 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
10.0%
5/50 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
9.1%
2/22 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
9.7%
7/72 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
|
Investigations
Alanine Aminotransferase Increased
|
4.0%
1/25 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
6.0%
3/50 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
4.5%
1/22 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
5.6%
4/72 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
|
Investigations
Aspartate Aminotransferase Increased
|
8.0%
2/25 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
4.0%
2/50 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
4.5%
1/22 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
4.2%
3/72 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
|
Investigations
Blood Thyroid Stimulating Hormone Increased
|
0.00%
0/25 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
6.0%
3/50 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
0.00%
0/22 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
4.2%
3/72 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
|
Investigations
Low Density Lipoprotein Increased
|
0.00%
0/25 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
6.0%
3/50 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
0.00%
0/22 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
4.2%
3/72 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
|
Investigations
Weight Decreased
|
0.00%
0/25 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
20.0%
10/50 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
9.1%
2/22 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
16.7%
12/72 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/25 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
8.0%
4/50 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
4.5%
1/22 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
6.9%
5/72 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/25 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
20.0%
10/50 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
13.6%
3/22 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
18.1%
13/72 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/25 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
10.0%
5/50 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
0.00%
0/22 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
6.9%
5/72 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
4.0%
1/25 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
4.0%
2/50 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
9.1%
2/22 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
5.6%
4/72 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/25 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
6.0%
3/50 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
4.5%
1/22 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
5.6%
4/72 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
4.0%
1/25 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
6.0%
3/50 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
4.5%
1/22 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
5.6%
4/72 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/25 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
6.0%
3/50 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
0.00%
0/22 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
4.2%
3/72 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/25 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
6.0%
3/50 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
0.00%
0/22 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
4.2%
3/72 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
0.00%
0/25 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
6.0%
3/50 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
4.5%
1/22 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
5.6%
4/72 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/25 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
0.00%
0/50 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
9.1%
2/22 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
2.8%
2/72 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Allergic
|
0.00%
0/25 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
2.0%
1/50 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
9.1%
2/22 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
4.2%
3/72 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/25 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
6.0%
3/50 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
4.5%
1/22 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
5.6%
4/72 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.0%
1/25 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
10.0%
5/50 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
4.5%
1/22 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
8.3%
6/72 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
|
Skin and subcutaneous tissue disorders
Rash
|
12.0%
3/25 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
28.0%
14/50 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
18.2%
4/22 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
25.0%
18/72 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
|
0.00%
0/25 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
6.0%
3/50 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
0.00%
0/22 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
4.2%
3/72 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
|
Vascular disorders
Hypertension
|
8.0%
2/25 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
22.0%
11/50 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
13.6%
3/22 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
19.4%
14/72 • Serious adverse events (AEs) and other AEs: From Cycle 1 Day 1 up to 30 days post last dose of study drug (up to 38.3 months); all-cause mortality: from Cycle 1 Day 1 up to 3 years and 3 months
The safety analysis set included all randomized participants who had received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. "All participants: Apalutamide" 240 mg Plus ADT arm presents combined data for participants treated with Apalutamide + ADT which included participants from original apalutamide arm and those who crossed over from placebo arm.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days to allow for filing of a patent application.
- Publication restrictions are in place
Restriction type: OTHER