NCT01995513 · OUTCOME
Percentage of Participants With Treatment-Emergent Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)
Safety Study of Continued Enzalutamide Treatment In Prostate Cancer Patients · Source last updated 2023-09-18
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
- Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum of 99.4 months)
What was measured
Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. 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 30 days after last dose of study drug that were absent before treatment or that worsened relative to pre-treatment state. Relatedness to study drug was assessed by the investigator.
Analysis population: Safety population included all participants who received any amount of study drug. "Number Analyzed" signifies participants evaluable for the specified categories for respective arms.
Groups in this outcome
Enzalutamide 160 mg
Participants who only received enzalutamide 160 mg as four 40 mg capsules, orally once daily in the study.
Enzalutamide Crossing Over to Abiraterone + Prednisone
Participants who received (after switching from enzalutamide), abiraterone 1000 mg as four 250 mg tablets, orally once daily and prednisone 10 mg administered as two 5 mg tablets, orally twice daily in the study.
Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg
Participants who received enzalutamide 160 mg as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in the study.
Placebo+Abiraterone 1000mg+ Prednisone 10mg
Participants who received placebo matched to enzalutamide as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in the study.
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 | 509 |
|---|
| Enzalutamide Crossing Over to Abiraterone + Prednisone | 13 |
|---|
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | 125 |
|---|
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | 124 |
|---|
Reported measurements
TEAEs related to Enzalutamide or Placebo
Analysis denominator · Participants
| Group | Source count |
|---|
| Enzalutamide 160 mg | 509 |
|---|
| Enzalutamide Crossing Over to Abiraterone + Prednisone | 0 |
|---|
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | 125 |
|---|
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | 124 |
|---|
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Enzalutamide 160 mg | 66.6 | Not reported | Not reported | Not reported | Not reported |
|---|
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | 46.4 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | 36.3 | Not reported | Not reported | Not reported | Not reported |
|---|
TEAEs related to Abiraterone
Analysis denominator · Participants
| Group | Source count |
|---|
| Enzalutamide 160 mg | 0 |
|---|
| Enzalutamide Crossing Over to Abiraterone + Prednisone | 13 |
|---|
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | 125 |
|---|
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | 124 |
|---|
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Enzalutamide Crossing Over to Abiraterone + Prednisone | 38.5 | Not reported | Not reported | Not reported | Not reported |
|---|
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | 54.4 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | 45.2 | Not reported | Not reported | Not reported | Not reported |
|---|
TEAEs related to Prednisone
Analysis denominator · Participants
| Group | Source count |
|---|
| Enzalutamide 160 mg | 0 |
|---|
| Enzalutamide Crossing Over to Abiraterone + Prednisone | 13 |
|---|
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | 125 |
|---|
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | 124 |
|---|
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Enzalutamide Crossing Over to Abiraterone + Prednisone | 7.7 | Not reported | Not reported | Not reported | Not reported |
|---|
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | 36.0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | 32.3 | Not reported | Not reported | Not reported | Not reported |
|---|
SAEs related to Enzalutamide or Placebo
Analysis denominator · Participants
| Group | Source count |
|---|
| Enzalutamide 160 mg | 509 |
|---|
| Enzalutamide Crossing Over to Abiraterone + Prednisone | 0 |
|---|
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | 125 |
|---|
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | 124 |
|---|
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Enzalutamide 160 mg | 4.1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | 7.2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | 4.8 | Not reported | Not reported | Not reported | Not reported |
|---|
SAEs related to Abiraterone
Analysis denominator · Participants
| Group | Source count |
|---|
| Enzalutamide 160 mg | 0 |
|---|
| Enzalutamide Crossing Over to Abiraterone + Prednisone | 13 |
|---|
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | 125 |
|---|
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | 124 |
|---|
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Enzalutamide Crossing Over to Abiraterone + Prednisone | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | 7.2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | 4.0 | Not reported | Not reported | Not reported | Not reported |
|---|
SAEs related to Prednisone
Analysis denominator · Participants
| Group | Source count |
|---|
| Enzalutamide 160 mg | 0 |
|---|
| Enzalutamide Crossing Over to Abiraterone + Prednisone | 13 |
|---|
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | 125 |
|---|
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | 124 |
|---|
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Enzalutamide Crossing Over to Abiraterone + Prednisone | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | 2.4 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | 4.8 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 66.6
- group Id
- OG002
- value
- 46.4
- group Id
- OG003
- value
- 36.3
- denoms
- counts
- group Id
- OG000
- value
- 509
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 125
- group Id
- OG003
- value
- 124
- units
- Participants
- title
- TEAEs related to Enzalutamide or Placebo
- categories
- measurements
- group Id
- OG001
- value
- 38.5
- group Id
- OG002
- value
- 54.4
- group Id
- OG003
- value
- 45.2
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 13
- group Id
- OG002
- value
- 125
- group Id
- OG003
- value
- 124
- units
- Participants
- title
- TEAEs related to Abiraterone
- categories
- measurements
- group Id
- OG001
- value
- 7.7
- group Id
- OG002
- value
- 36.0
- group Id
- OG003
- value
- 32.3
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 13
- group Id
- OG002
- value
- 125
- group Id
- OG003
- value
- 124
- units
- Participants
- title
- TEAEs related to Prednisone
- categories
- measurements
- group Id
- OG000
- value
- 4.1
- group Id
- OG002
- value
- 7.2
- group Id
- OG003
- value
- 4.8
- denoms
- counts
- group Id
- OG000
- value
- 509
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 125
- group Id
- OG003
- value
- 124
- units
- Participants
- title
- SAEs related to Enzalutamide or Placebo
- categories
- measurements
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 7.2
- group Id
- OG003
- value
- 4.0
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 13
- group Id
- OG002
- value
- 125
- group Id
- OG003
- value
- 124
- units
- Participants
- title
- SAEs related to Abiraterone
- categories
- measurements
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 2.4
- group Id
- OG003
- value
- 4.8
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 13
- group Id
- OG002
- value
- 125
- group Id
- OG003
- value
- 124
- units
- Participants
- title
- SAEs related to Prednisone
- denoms
- counts
- group Id
- OG000
- value
- 509
- group Id
- OG001
- value
- 13
- group Id
- OG002
- value
- 125
- group Id
- OG003
- value
- 124
- units
- Participants
- description
- Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. 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 30 days after last dose of study drug that were absent before treatment or that worsened relative to pre-treatment state. Relatedness to study drug was assessed by the investigator.
- groups
- description
- Participants who only received enzalutamide 160 mg as four 40 mg capsules, orally once daily in the study.
- id
- OG000
- title
- Enzalutamide 160 mg
- description
- Participants who received (after switching from enzalutamide), abiraterone 1000 mg as four 250 mg tablets, orally once daily and prednisone 10 mg administered as two 5 mg tablets, orally twice daily in the study.
- id
- OG001
- title
- Enzalutamide Crossing Over to Abiraterone + Prednisone
- description
- Participants who received enzalutamide 160 mg as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in the study.
- id
- OG002
- title
- Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg
- description
- Participants who received placebo matched to enzalutamide as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in the study.
- id
- OG003
- title
- Placebo+Abiraterone 1000mg+ Prednisone 10mg
- param Type
- NUMBER
- population Description
- Safety population included all participants who received any amount of study drug. "Number Analyzed" signifies participants evaluable for the specified categories for respective arms.
- reporting Status
- POSTED
- time Frame
- Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum of 99.4 months)
- title
- Percentage of Participants With Treatment-Emergent Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)
- type
- OTHER_PRE_SPECIFIED
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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