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NCT01664923 · OUTCOME

Percentage of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

Safety and Efficacy Study of Enzalutamide Versus Bicalutamide in Men With Prostate Cancer · Source last updated 2019-01-30

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
From first dose of study drug until the end of open label phase (up to maximum duration of 65 months)

What was measured

An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. An SAE was an AE resulting in any of following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly. A treatment emergent AE defined as an event that emerged during treatment period (From first dose of study drug until end of open label phase \[up to maximum duration of 65 months\]) that was absent before treatment, or worsened during treatment period relative to pre-treatment state. AE included both serious and non- SAE. Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An AE was considered related to study drug if event was assessed by investigator as probably or possibly related.

Analysis population: Safety population included all participants who received at least 1 dose of study drug.

Groups in this outcome

Enzalutamide

Participants received enzalutamide 160 mg, self-administered as four 40-mg capsules, and 1 bicalutamide matching placebo capsule once per day, by mouth for up to 29 months in DB phase. Participants who completed DB phase and consented to participate in open label phase, received enzalutamide 160 mg, self-administered as four 40-mg capsules once per day by mouth for up to 36 months in open label phase.

DB Phase: Bicalutamide

Participants received bicalutamide 50 mg, self-administered as 1 capsule, once per day by mouth and 4 enzalutamide matching placebo capsules for up to 29 months in DB phase.

Open Label Phase: Bicalutamide Crossover to Enzalutamide

Participants who received bicalutamide 50 mg in DB phase and consented to participate in open label phase, received enzalutamide 160 mg, self-administered as four 40-mg capsules, once per day by mouth in open label phase for up to 36 months.

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

Analysis denominator · Participants

GroupSource count
Enzalutamide197
DB Phase: Bicalutamide198
Open Label Phase: Bicalutamide Crossover to Enzalutamide37

Reported measurements

Any AE
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Enzalutamide96.4Not reportedNot reportedNot reportedNot reported
DB Phase: Bicalutamide90.4Not reportedNot reportedNot reportedNot reported
Open Label Phase: Bicalutamide Crossover to Enzalutamide97.3Not reportedNot reportedNot reportedNot reported
AE Leading to Study Drug Discontinuation
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Enzalutamide16.2Not reportedNot reportedNot reportedNot reported
DB Phase: Bicalutamide13.1Not reportedNot reportedNot reportedNot reported
Open Label Phase: Bicalutamide Crossover to Enzalutamide24.3Not reportedNot reportedNot reportedNot reported
AE Leading to Death
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Enzalutamide4.6Not reportedNot reportedNot reportedNot reported
DB Phase: Bicalutamide3.0Not reportedNot reportedNot reportedNot reported
Open Label Phase: Bicalutamide Crossover to Enzalutamide8.1Not reportedNot reportedNot reportedNot reported
Serious AE
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Enzalutamide38.6Not reportedNot reportedNot reportedNot reported
DB Phase: Bicalutamide30.3Not reportedNot reportedNot reportedNot reported
Open Label Phase: Bicalutamide Crossover to Enzalutamide43.2Not reportedNot reportedNot reportedNot reported
AE Related to Study Drug
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Enzalutamide66.5Not reportedNot reportedNot reportedNot reported
DB Phase: Bicalutamide53.5Not reportedNot reportedNot reportedNot reported
Open Label Phase: Bicalutamide Crossover to Enzalutamide70.3Not reportedNot reportedNot reportedNot reported
Serious AE Related to Study Drug
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Enzalutamide7.6Not reportedNot reportedNot reportedNot reported
DB Phase: Bicalutamide3.5Not reportedNot reportedNot reportedNot reported
Open Label Phase: Bicalutamide Crossover to Enzalutamide2.7Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        96.4
      2. group Id
        OG001
        value
        90.4
      3. group Id
        OG002
        value
        97.3
    title
    Any AE
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        16.2
      2. group Id
        OG001
        value
        13.1
      3. group Id
        OG002
        value
        24.3
    title
    AE Leading to Study Drug Discontinuation
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        4.6
      2. group Id
        OG001
        value
        3.0
      3. group Id
        OG002
        value
        8.1
    title
    AE Leading to Death
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        38.6
      2. group Id
        OG001
        value
        30.3
      3. group Id
        OG002
        value
        43.2
    title
    Serious AE
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        66.5
      2. group Id
        OG001
        value
        53.5
      3. group Id
        OG002
        value
        70.3
    title
    AE Related to Study Drug
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        7.6
      2. group Id
        OG001
        value
        3.5
      3. group Id
        OG002
        value
        2.7
    title
    Serious AE Related to Study Drug
denoms
  1. counts
    1. group Id
      OG000
      value
      197
    2. group Id
      OG001
      value
      198
    3. group Id
      OG002
      value
      37
    units
    Participants
description
An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. An SAE was an AE resulting in any of following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly. A treatment emergent AE defined as an event that emerged during treatment period (From first dose of study drug until end of open label phase \[up to maximum duration of 65 months\]) that was absent before treatment, or worsened during treatment period relative to pre-treatment state. AE included both serious and non- SAE. Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An AE was considered related to study drug if event was assessed by investigator as probably or possibly related.
groups
  1. description
    Participants received enzalutamide 160 mg, self-administered as four 40-mg capsules, and 1 bicalutamide matching placebo capsule once per day, by mouth for up to 29 months in DB phase. Participants who completed DB phase and consented to participate in open label phase, received enzalutamide 160 mg, self-administered as four 40-mg capsules once per day by mouth for up to 36 months in open label phase.
    id
    OG000
    title
    Enzalutamide
  2. description
    Participants received bicalutamide 50 mg, self-administered as 1 capsule, once per day by mouth and 4 enzalutamide matching placebo capsules for up to 29 months in DB phase.
    id
    OG001
    title
    DB Phase: Bicalutamide
  3. description
    Participants who received bicalutamide 50 mg in DB phase and consented to participate in open label phase, received enzalutamide 160 mg, self-administered as four 40-mg capsules, once per day by mouth in open label phase for up to 36 months.
    id
    OG002
    title
    Open Label Phase: Bicalutamide Crossover to Enzalutamide
param Type
NUMBER
population Description
Safety population included all participants who received at least 1 dose of study drug.
reporting Status
POSTED
time Frame
From first dose of study drug until the end of open label phase (up to maximum duration of 65 months)
title
Percentage of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice