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NCT01995513 · OUTCOME

Percentage of Participants With Adverse Events (AEs) Leading to Death

Safety Study of Continued Enzalutamide Treatment In Prostate Cancer Patients · Source last updated 2023-09-18

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
Not reported
Time frame
Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum of 99.4 months)

What was measured

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Outcome of an AE was response to a question answered by the investigator: 'Is the AE leading to study discontinuation or death?' as 'yes'.

Analysis population: Safety population included all participants who received any amount of study drug.

Groups in this outcome

Enzalutamide 160 mg

Participants who only received enzalutamide 160 mg as four 40 mg capsules, orally once daily in the study.

Enzalutamide Crossing Over to Abiraterone + Prednisone

Participants who received enzalutamide (after switching from enzalutamide), abiraterone 1000 mg as four 250 mg tablets, orally once daily and prednisone 10 mg administered as two 5 mg tablets, orally twice daily in the study.

Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg

Participants who received enzalutamide 160 mg as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in the study.

Placebo+Abiraterone 1000mg+ Prednisone 10mg

Participants who received placebo matched to enzalutamide as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in the study.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Enzalutamide 160 mg509
Enzalutamide Crossing Over to Abiraterone + Prednisone13
Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg125
Placebo+Abiraterone 1000mg+ Prednisone 10mg124

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Enzalutamide 160 mg5.9Not reportedNot reportedNot reportedNot reported
Enzalutamide Crossing Over to Abiraterone + Prednisone0Not reportedNot reportedNot reportedNot reported
Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg3.2Not reportedNot reportedNot reportedNot reported
Placebo+Abiraterone 1000mg+ Prednisone 10mg2.4Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        5.9
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        3.2
      4. group Id
        OG003
        value
        2.4
denoms
  1. counts
    1. group Id
      OG000
      value
      509
    2. group Id
      OG001
      value
      13
    3. group Id
      OG002
      value
      125
    4. group Id
      OG003
      value
      124
    units
    Participants
description
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Outcome of an AE was response to a question answered by the investigator: 'Is the AE leading to study discontinuation or death?' as 'yes'.
groups
  1. description
    Participants who only received enzalutamide 160 mg as four 40 mg capsules, orally once daily in the study.
    id
    OG000
    title
    Enzalutamide 160 mg
  2. description
    Participants who received enzalutamide (after switching from enzalutamide), abiraterone 1000 mg as four 250 mg tablets, orally once daily and prednisone 10 mg administered as two 5 mg tablets, orally twice daily in the study.
    id
    OG001
    title
    Enzalutamide Crossing Over to Abiraterone + Prednisone
  3. description
    Participants who received enzalutamide 160 mg as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in the study.
    id
    OG002
    title
    Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg
  4. description
    Participants who received placebo matched to enzalutamide as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in the study.
    id
    OG003
    title
    Placebo+Abiraterone 1000mg+ Prednisone 10mg
param Type
NUMBER
population Description
Safety population included all participants who received any amount of study drug.
reporting Status
POSTED
time Frame
Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum of 99.4 months)
title
Percentage of Participants With Adverse Events (AEs) Leading to Death
type
OTHER_PRE_SPECIFIED
unit Of Measure
percentage of participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice