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 - Chemistry
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
Chemistry parameters: Alanine aminotransferase (units per liter \[U/L\]); albumin (g/L); alkaline phosphatase (U/L); bilirubin (micromoles per liter \[umol/L\]); calcium (millimoles per liter \[mmol/L\]); creatine kinase (U/L); creatinine (umol/L); glucose, magnesium, phosphate, potassium, sodium (mmol/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
Group
Source count
Enzalutamide 160 mg
930
Placebo
465
Reported measurements
Alanine Aminotransferase (High)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Enzalutamide 160 mg
4
Not reported
Not reported
Not reported
Not reported
Placebo
1
Not reported
Not reported
Not reported
Not reported
Albumin (Low)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Enzalutamide 160 mg
7
Not reported
Not reported
Not reported
Not reported
Placebo
0
Not reported
Not reported
Not reported
Not reported
Alkaline Phosphatase (High)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Enzalutamide 160 mg
3
Not reported
Not reported
Not reported
Not reported
Placebo
6
Not reported
Not reported
Not reported
Not reported
Aspartate Aminotransferase (High)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Enzalutamide 160 mg
3
Not reported
Not reported
Not reported
Not reported
Placebo
1
Not reported
Not reported
Not reported
Not reported
Bilirubin (High)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Enzalutamide 160 mg
4
Not reported
Not reported
Not reported
Not reported
Placebo
1
Not reported
Not reported
Not reported
Not reported
Calcium (High)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Enzalutamide 160 mg
1
Not reported
Not reported
Not reported
Not reported
Placebo
1
Not reported
Not reported
Not reported
Not reported
Calcium (Low)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Enzalutamide 160 mg
2
Not reported
Not reported
Not reported
Not reported
Placebo
1
Not reported
Not reported
Not reported
Not reported
Creatine Kinase (High)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Enzalutamide 160 mg
4
Not reported
Not reported
Not reported
Not reported
Placebo
3
Not reported
Not reported
Not reported
Not reported
Creatinine (High)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Enzalutamide 160 mg
1
Not reported
Not reported
Not reported
Not reported
Placebo
7
Not reported
Not reported
Not reported
Not reported
Glucose (High)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Enzalutamide 160 mg
26
Not reported
Not reported
Not reported
Not reported
Placebo
8
Not reported
Not reported
Not reported
Not reported
Glucose (Low)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Enzalutamide 160 mg
5
Not reported
Not reported
Not reported
Not reported
Placebo
1
Not reported
Not reported
Not reported
Not reported
Magnesium (High)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Enzalutamide 160 mg
1
Not reported
Not reported
Not reported
Not reported
Placebo
0
Not reported
Not reported
Not reported
Not reported
Magnesium (Low)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Enzalutamide 160 mg
1
Not reported
Not reported
Not reported
Not reported
Placebo
0
Not reported
Not reported
Not reported
Not reported
Phosphate (Low)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Enzalutamide 160 mg
30
Not reported
Not reported
Not reported
Not reported
Placebo
13
Not reported
Not reported
Not reported
Not reported
Potassium (High)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Enzalutamide 160 mg
14
Not reported
Not reported
Not reported
Not reported
Placebo
5
Not reported
Not reported
Not reported
Not reported
Potassium (Low)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Enzalutamide 160 mg
0
Not reported
Not reported
Not reported
Not reported
Placebo
3
Not reported
Not reported
Not reported
Not reported
Sodium (High)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Enzalutamide 160 mg
2
Not reported
Not reported
Not reported
Not reported
Placebo
1
Not reported
Not reported
Not reported
Not reported
Sodium (Low)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Enzalutamide 160 mg
12
Not reported
Not reported
Not reported
Not reported
Placebo
7
Not reported
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
value
4
group Id
OG001
value
1
title
Alanine Aminotransferase (High)
categories
measurements
group Id
OG000
value
7
group Id
OG001
value
0
title
Albumin (Low)
categories
measurements
group Id
OG000
value
3
group Id
OG001
value
6
title
Alkaline Phosphatase (High)
categories
measurements
group Id
OG000
value
3
group Id
OG001
value
1
title
Aspartate Aminotransferase (High)
categories
measurements
group Id
OG000
value
4
group Id
OG001
value
1
title
Bilirubin (High)
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
1
title
Calcium (High)
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
1
title
Calcium (Low)
categories
measurements
group Id
OG000
value
4
group Id
OG001
value
3
title
Creatine Kinase (High)
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
7
title
Creatinine (High)
categories
measurements
group Id
OG000
value
26
group Id
OG001
value
8
title
Glucose (High)
categories
measurements
group Id
OG000
value
5
group Id
OG001
value
1
title
Glucose (Low)
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
0
title
Magnesium (High)
denoms
counts
group Id
OG000
value
930
group Id
OG001
value
465
units
Participants
description
Chemistry parameters: Alanine aminotransferase (units per liter \[U/L\]); albumin (g/L); alkaline phosphatase (U/L); bilirubin (micromoles per liter \[umol/L\]); calcium (millimoles per liter \[mmol/L\]); creatine kinase (U/L); creatinine (umol/L); glucose, magnesium, phosphate, potassium, sodium (mmol/L).
groups
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
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 - Chemistry
Triangle