Number of Participants With Grade 3/4 Post-Baseline Laboratory Toxicity (Hematology and Chemistry)
Safety and Efficacy Study of MDV3100 in Patients With Castration-Resistant Prostate Cancer Who Have Been Previously Treated With Docetaxel-based Chemotherapy · Source last updated 2018-12-11
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, up to the safety follow-up visit or unscheduled visit or the initiation of another anti-neoplastic therapy whichever occurred first (up to 101 months)
What was measured
Laboratory parameters included hematological and chemistry parameters. Chemistry parameters included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bilirubin, calcium, creatine kinase, creatinine, glucose, magnesium, phosphate, potassium and sodium. Hematology parameters included haemoglobin, leukocytes, lymphocytes, neutrophils and platelet. Test abnormalities were graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03 as Grade 3= severe and Grade 4= life-threatening or disabling. Only categories with at least 1 participant with abnormality are reported in this outcome measure. Unscheduled visit was performed at any time during the study whenever necessary to assess for or follow-up on AEs, at the participant's request or if deemed necessary by the investigator.
Analysis population: Safety population was defined as all randomized participants who received at least 1 dose of study drug.
Groups in this outcome
Enzalutamide
In DB Phase, participants received Enzalutamide capsules 160 mg orally per day. Participants who completed DB Phase, entered in optional OLE Phase and received same treatment until unacceptable toxicity, confirmed disease progression and the participant was scheduled to initiate a new systemic anti-neoplastic therapy, death or withdrawal (median treatment duration was 8.3 months).
Placebo: DB Phase
In DB Phase, participants received placebo capsules (for Enzalutamide) orally per day until unacceptable toxicity, confirmed disease progression and the participant was scheduled to initiate a new systemic anti-neoplastic therapy, death or withdrawal (median treatment duration was 3.0 months).
Placebo (DB) /Enzalutamide 160 mg (OLE) Phase
Participants who received placebo in DB phase, completed DB Phase and entered in optional OLE Phase, received Enzalutamide capsules 160 mg orally per day until unacceptable toxicity, confirmed disease progression and the participant was scheduled to initiate a new systemic anti-neoplastic therapy, death or withdrawal (median treatment duration was 7.7 months).
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
800
Placebo: DB Phase
399
Placebo (DB) /Enzalutamide 160 mg (OLE) Phase
50
Reported measurements
Alanine Aminotransferase:High
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Enzalutamide
2
Not reported
Not reported
Not reported
Not reported
Placebo: DB Phase
2
Not reported
Not reported
Not reported
Not reported
Placebo (DB) /Enzalutamide 160 mg (OLE) Phase
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
7
Not reported
Not reported
Not reported
Not reported
Placebo: DB Phase
3
Not reported
Not reported
Not reported
Not reported
Placebo (DB) /Enzalutamide 160 mg (OLE) Phase
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
102
Not reported
Not reported
Not reported
Not reported
Placebo: DB Phase
74
Not reported
Not reported
Not reported
Not reported
Placebo (DB) /Enzalutamide 160 mg (OLE) Phase
3
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
3
Not reported
Not reported
Not reported
Not reported
Placebo: DB Phase
4
Not reported
Not reported
Not reported
Not reported
Placebo (DB) /Enzalutamide 160 mg (OLE) Phase
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
2
Not reported
Not reported
Not reported
Not reported
Placebo: DB Phase
0
Not reported
Not reported
Not reported
Not reported
Placebo (DB) /Enzalutamide 160 mg (OLE) Phase
0
Not reported
Not reported
Not reported
Not reported
Calcium: Low
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Enzalutamide
14
Not reported
Not reported
Not reported
Not reported
Placebo: DB Phase
15
Not reported
Not reported
Not reported
Not reported
Placebo (DB) /Enzalutamide 160 mg (OLE) Phase
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
1
Not reported
Not reported
Not reported
Not reported
Placebo: DB Phase
0
Not reported
Not reported
Not reported
Not reported
Placebo (DB) /Enzalutamide 160 mg (OLE) Phase
0
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
4
Not reported
Not reported
Not reported
Not reported
Placebo: DB Phase
2
Not reported
Not reported
Not reported
Not reported
Placebo (DB) /Enzalutamide 160 mg (OLE) Phase
0
Not reported
Not reported
Not reported
Not reported
Creatinine: High
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Enzalutamide
0
Not reported
Not reported
Not reported
Not reported
Placebo: DB Phase
2
Not reported
Not reported
Not reported
Not reported
Placebo (DB) /Enzalutamide 160 mg (OLE) Phase
0
Not reported
Not reported
Not reported
Not reported
Glucose: High
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Enzalutamide
17
Not reported
Not reported
Not reported
Not reported
Placebo: DB Phase
10
Not reported
Not reported
Not reported
Not reported
Placebo (DB) /Enzalutamide 160 mg (OLE) Phase
1
Not reported
Not reported
Not reported
Not reported
Magnesium: Low
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Enzalutamide
0
Not reported
Not reported
Not reported
Not reported
Placebo: DB Phase
1
Not reported
Not reported
Not reported
Not reported
Placebo (DB) /Enzalutamide 160 mg (OLE) Phase
0
Not reported
Not reported
Not reported
Not reported
Magnesium: High
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Enzalutamide
1
Not reported
Not reported
Not reported
Not reported
Placebo: DB Phase
1
Not reported
Not reported
Not reported
Not reported
Placebo (DB) /Enzalutamide 160 mg (OLE) Phase
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
28
Not reported
Not reported
Not reported
Not reported
Placebo: DB Phase
10
Not reported
Not reported
Not reported
Not reported
Placebo (DB) /Enzalutamide 160 mg (OLE) Phase
2
Not reported
Not reported
Not reported
Not reported
Potassium: Low
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Enzalutamide
7
Not reported
Not reported
Not reported
Not reported
Placebo: DB Phase
4
Not reported
Not reported
Not reported
Not reported
Placebo (DB) /Enzalutamide 160 mg (OLE) Phase
1
Not reported
Not reported
Not reported
Not reported
Potassium: High
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Enzalutamide
2
Not reported
Not reported
Not reported
Not reported
Placebo: DB Phase
3
Not reported
Not reported
Not reported
Not reported
Placebo (DB) /Enzalutamide 160 mg (OLE) Phase
0
Not reported
Not reported
Not reported
Not reported
Sodium: Low
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Enzalutamide
19
Not reported
Not reported
Not reported
Not reported
Placebo: DB Phase
13
Not reported
Not reported
Not reported
Not reported
Placebo (DB) /Enzalutamide 160 mg (OLE) Phase
0
Not reported
Not reported
Not reported
Not reported
Sodium: High
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Enzalutamide
0
Not reported
Not reported
Not reported
Not reported
Placebo: DB Phase
1
Not reported
Not reported
Not reported
Not reported
Placebo (DB) /Enzalutamide 160 mg (OLE) Phase
0
Not reported
Not reported
Not reported
Not reported
Hemoglobin: Low
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Enzalutamide
38
Not reported
Not reported
Not reported
Not reported
Placebo: DB Phase
20
Not reported
Not reported
Not reported
Not reported
Placebo (DB) /Enzalutamide 160 mg (OLE) Phase
4
Not reported
Not reported
Not reported
Not reported
Hemoglobin: High
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Enzalutamide
1
Not reported
Not reported
Not reported
Not reported
Placebo: DB Phase
0
Not reported
Not reported
Not reported
Not reported
Placebo (DB) /Enzalutamide 160 mg (OLE) Phase
0
Not reported
Not reported
Not reported
Not reported
Leukocytes: Low
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Enzalutamide
8
Not reported
Not reported
Not reported
Not reported
Placebo: DB Phase
1
Not reported
Not reported
Not reported
Not reported
Placebo (DB) /Enzalutamide 160 mg (OLE) Phase
1
Not reported
Not reported
Not reported
Not reported
Lymphocytes: Low
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Enzalutamide
80
Not reported
Not reported
Not reported
Not reported
Placebo: DB Phase
48
Not reported
Not reported
Not reported
Not reported
Placebo (DB) /Enzalutamide 160 mg (OLE) Phase
5
Not reported
Not reported
Not reported
Not reported
Neutrophils: Low
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Enzalutamide
10
Not reported
Not reported
Not reported
Not reported
Placebo: DB Phase
0
Not reported
Not reported
Not reported
Not reported
Placebo (DB) /Enzalutamide 160 mg (OLE) Phase
1
Not reported
Not reported
Not reported
Not reported
Platelet; Low
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Enzalutamide
4
Not reported
Not reported
Not reported
Not reported
Placebo: DB Phase
4
Not reported
Not reported
Not reported
Not reported
Placebo (DB) /Enzalutamide 160 mg (OLE) Phase
0
Not reported
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
2
group Id
OG002
value
1
title
Alanine Aminotransferase:High
categories
measurements
group Id
OG000
value
7
group Id
OG001
value
3
group Id
OG002
value
0
title
Albumin: Low
categories
measurements
group Id
OG000
value
102
group Id
OG001
value
74
group Id
OG002
value
3
title
Alkaline Phosphatase: High
categories
measurements
group Id
OG000
value
3
group Id
OG001
value
4
group Id
OG002
value
1
title
Aspartate Aminotransferase: High
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
0
group Id
OG002
value
0
title
Bilirubin: High
categories
measurements
group Id
OG000
value
14
group Id
OG001
value
15
group Id
OG002
value
1
title
Calcium: Low
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
0
group Id
OG002
value
0
title
Calcium: High
categories
measurements
group Id
OG000
value
4
group Id
OG001
value
2
group Id
OG002
value
0
title
Creatine Kinase: High
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
2
group Id
OG002
value
0
title
Creatinine: High
categories
measurements
group Id
OG000
value
17
group Id
OG001
value
10
group Id
OG002
value
1
title
Glucose: High
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
1
group Id
OG002
value
0
title
Magnesium: Low
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
1
group Id
OG002
value
0
title
Magnesium: High
denoms
counts
group Id
OG000
value
800
group Id
OG001
value
399
group Id
OG002
value
50
units
Participants
description
Laboratory parameters included hematological and chemistry parameters. Chemistry parameters included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bilirubin, calcium, creatine kinase, creatinine, glucose, magnesium, phosphate, potassium and sodium. Hematology parameters included haemoglobin, leukocytes, lymphocytes, neutrophils and platelet. Test abnormalities were graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03 as Grade 3= severe and Grade 4= life-threatening or disabling. Only categories with at least 1 participant with abnormality are reported in this outcome measure. Unscheduled visit was performed at any time during the study whenever necessary to assess for or follow-up on AEs, at the participant's request or if deemed necessary by the investigator.
groups
description
In DB Phase, participants received Enzalutamide capsules 160 mg orally per day. Participants who completed DB Phase, entered in optional OLE Phase and received same treatment until unacceptable toxicity, confirmed disease progression and the participant was scheduled to initiate a new systemic anti-neoplastic therapy, death or withdrawal (median treatment duration was 8.3 months).
id
OG000
title
Enzalutamide
description
In DB Phase, participants received placebo capsules (for Enzalutamide) orally per day until unacceptable toxicity, confirmed disease progression and the participant was scheduled to initiate a new systemic anti-neoplastic therapy, death or withdrawal (median treatment duration was 3.0 months).
id
OG001
title
Placebo: DB Phase
description
Participants who received placebo in DB phase, completed DB Phase and entered in optional OLE Phase, received Enzalutamide capsules 160 mg orally per day until unacceptable toxicity, confirmed disease progression and the participant was scheduled to initiate a new systemic anti-neoplastic therapy, death or withdrawal (median treatment duration was 7.7 months).
id
OG002
title
Placebo (DB) /Enzalutamide 160 mg (OLE) Phase
param Type
COUNT_OF_PARTICIPANTS
population Description
Safety population was defined as all randomized participants who received at least 1 dose of study drug.
reporting Status
POSTED
time Frame
Baseline, up to the safety follow-up visit or unscheduled visit or the initiation of another anti-neoplastic therapy whichever occurred first (up to 101 months)
title
Number of Participants With Grade 3/4 Post-Baseline Laboratory Toxicity (Hematology and Chemistry)
Triangle