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NCT01212991 · OUTCOME

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

A Safety and Efficacy Study of Oral MDV3100 in Chemotherapy-Naive Patients With Progressive Metastatic Prostate Cancer · Source last updated 2020-03-17

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

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years)

What was measured

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the 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/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to a maximum of 6.5 years that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious AEs.

Analysis population: The safety analysis set included all randomized participants who received at least 1 dose or partial dose of study drug.

Groups in this outcome

Enzalutamide

Participants received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.

Placebo

Participants received placebo, administered as four capsules, once per day by mouth.

Placebo Participants Crossover to Enzalutamide

Participants who received placebo in double-blind period and who agreed to proceed to open-label phase period, received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.

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

Analysis denominator · Participants

GroupSource count
Enzalutamide871
Placebo844
Placebo Participants Crossover to Enzalutamide234

Reported measurements

AEs
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Enzalutamide857Not reportedNot reportedNot reportedNot reported
Placebo791Not reportedNot reportedNot reportedNot reported
Placebo Participants Crossover to Enzalutamide212Not reportedNot reportedNot reportedNot reported
SAEs
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Enzalutamide384Not reportedNot reportedNot reportedNot reported
Placebo229Not reportedNot reportedNot reportedNot reported
Placebo Participants Crossover to Enzalutamide104Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        857
      2. group Id
        OG001
        value
        791
      3. group Id
        OG002
        value
        212
    title
    AEs
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        384
      2. group Id
        OG001
        value
        229
      3. group Id
        OG002
        value
        104
    title
    SAEs
denoms
  1. counts
    1. group Id
      OG000
      value
      871
    2. group Id
      OG001
      value
      844
    3. group Id
      OG002
      value
      234
    units
    Participants
description
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the 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/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to a maximum of 6.5 years that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious AEs.
groups
  1. description
    Participants received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.
    id
    OG000
    title
    Enzalutamide
  2. description
    Participants received placebo, administered as four capsules, once per day by mouth.
    id
    OG001
    title
    Placebo
  3. description
    Participants who received placebo in double-blind period and who agreed to proceed to open-label phase period, received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.
    id
    OG002
    title
    Placebo Participants Crossover to Enzalutamide
param Type
COUNT_OF_PARTICIPANTS
population Description
The safety analysis set included all randomized participants who received at least 1 dose or partial dose of study drug.
reporting Status
POSTED
time Frame
Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years)
title
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
type
OTHER_PRE_SPECIFIED
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice