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NCT02003924 · OUTCOME

Number of Participants With Increase of 2 or More National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) (Version 4.0) Toxicity Grades Above Baseline - Hematology

Safety and Efficacy Study of Enzalutamide in Patients With Nonmetastatic Castration-Resistant Prostate Cancer · Source last updated 2026-01-27

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
From first dose of study drug to the last dose + 30 days (or the day before initiation of a new antineoplastic treatment, whichever occurred first) (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)

What was measured

Hematology parameters: Haemoglobin (grams per liter \[g/L\]); leukocytes (log 10 raised to power 9 per liter \[10\*9/L\]); lymphocytes (log 10 raised to power 6 per liter \[10\*6/L\]); neutrophils (log 10 raised to power 6 per liter \[10\*6/L\]); platelets (log 10 raised to power 9 per litre \[10\*9/L\]).

Analysis population: The safety population was defined as all participants randomly assigned to receive at least 1 dose or partial dose of study drug (enzalutamide or placebo) according to the actual treatment received (not the treatment assigned).

Groups in this outcome

Enzalutamide 160 mg

Participants received 4 capsules of Enzalutamide 40 mg each (total dose 160 mg per day) orally, once daily in double-blind and open-label phase (up to a maximum of 68.8 months) until radiographic progression. Participants after last dose of study drug, were followed up for safety up to 30 days, and were long term followed up (for survival status and new prostate cancer therapies) from last dose to the death date or last known survival date.

Placebo

Participants received 4 capsules of placebo (matched to Enzalutamide) orally, once daily in double blind phase (up to a maximum of 51.3 months) until radiographic progression. Participants were given an opportunity to switch to open-label enzalutamide after completion of double blind phase. Participants after last dose of study drug, were followed up for safety up to 30 days and were long term followed up (for survival status and new prostate cancer therapies) to the death date or last known survival date.

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 mg930
Placebo465

Reported measurements

Haemoglobin (Low)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Enzalutamide 160 mg12Not reportedNot reportedNot reportedNot reported
Placebo7Not reportedNot reportedNot reportedNot reported
Leukocytes (Low)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Enzalutamide 160 mg7Not reportedNot reportedNot reportedNot reported
Placebo7Not reportedNot reportedNot reportedNot reported
Lymphocytes (High)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Enzalutamide 160 mg4Not reportedNot reportedNot reportedNot reported
Placebo2Not reportedNot reportedNot reportedNot reported
Lymphocytes (Low)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Enzalutamide 160 mg44Not reportedNot reportedNot reportedNot reported
Placebo26Not reportedNot reportedNot reportedNot reported
Neutrophils (Low)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Enzalutamide 160 mg13Not reportedNot reportedNot reportedNot reported
Placebo4Not reportedNot reportedNot reportedNot reported
Platelets (Low)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Enzalutamide 160 mg3Not reportedNot reportedNot reportedNot reported
Placebo2Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        12
      2. group Id
        OG001
        value
        7
    title
    Haemoglobin (Low)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        7
      2. group Id
        OG001
        value
        7
    title
    Leukocytes (Low)
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        2
    title
    Lymphocytes (High)
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        44
      2. group Id
        OG001
        value
        26
    title
    Lymphocytes (Low)
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        13
      2. group Id
        OG001
        value
        4
    title
    Neutrophils (Low)
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        2
    title
    Platelets (Low)
denoms
  1. counts
    1. group Id
      OG000
      value
      930
    2. group Id
      OG001
      value
      465
    units
    Participants
description
Hematology parameters: Haemoglobin (grams per liter \[g/L\]); leukocytes (log 10 raised to power 9 per liter \[10\*9/L\]); lymphocytes (log 10 raised to power 6 per liter \[10\*6/L\]); neutrophils (log 10 raised to power 6 per liter \[10\*6/L\]); platelets (log 10 raised to power 9 per litre \[10\*9/L\]).
groups
  1. description
    Participants received 4 capsules of Enzalutamide 40 mg each (total dose 160 mg per day) orally, once daily in double-blind and open-label phase (up to a maximum of 68.8 months) until radiographic progression. Participants after last dose of study drug, were followed up for safety up to 30 days, and were long term followed up (for survival status and new prostate cancer therapies) from last dose to the death date or last known survival date.
    id
    OG000
    title
    Enzalutamide 160 mg
  2. description
    Participants received 4 capsules of placebo (matched to Enzalutamide) orally, once daily in double blind phase (up to a maximum of 51.3 months) until radiographic progression. Participants were given an opportunity to switch to open-label enzalutamide after completion of double blind phase. Participants after last dose of study drug, were followed up for safety up to 30 days and were long term followed up (for survival status and new prostate cancer therapies) to the death date or last known survival date.
    id
    OG001
    title
    Placebo
param Type
COUNT_OF_PARTICIPANTS
population Description
The safety population was defined as all participants randomly assigned to receive at least 1 dose or partial dose of study drug (enzalutamide or placebo) according to the actual treatment received (not the treatment assigned).
reporting Status
POSTED
time Frame
From first dose of study drug to the last dose + 30 days (or the day before initiation of a new antineoplastic treatment, whichever occurred first) (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)
title
Number of Participants With Increase of 2 or More National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) (Version 4.0) Toxicity Grades Above Baseline - Hematology
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice