NCT02294461 · OUTCOME
Number of Participants With Adverse Events (AE)
An Asian Study to Evaluate Efficacy and Safety of Oral Enzalutamide in Progressive Metastatic Prostate Cancer Participants · Source last updated 2025-10-24
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- From first dose on Day 1 until 28 days after the last dose of study drug, or one day before the date of initiation of cytotoxic chemotherapy or an investigational agent for treatment of prostate cancer, whichever comes first, up to 123 months and 24 days
What was measured
An AE was defined as any untoward medical occurrence, temporally associated with use of medicinal product, whether considered related to medicinal product. AE could therefore be any unfavorable \& unintended sign, symptom, or disease temporally associated with use of a medicinal product. An AE was considered serious if, results in death; is life-threatening; results in persistent disability; results in congenital anomaly; requires inpatient hospitalization; or leads to prolongation of hospitalization; other medically important events. TEAE was defined as AE occurring from time of study drug administration on Day 1 until follow-up visit (28 days after last dose, or one day before date of initiation of cytotoxic chemotherapy or an investigational agent, whichever comes first). AEs were graded using National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03, where Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Life-threatening; Grade 5 = Fatal.
Analysis population: Safety Analysis Set consisted of all randomized participants who received at least 1 dose of study drug.
Groups in this outcome
Enzalutamide
Participants received 160 mg of enzalutamide orally once a day during double blind period until PSA progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer (up to 29.4 months). Eligible participants who received enzalutamide during double blind and who provided consent to take part in open-label period continued to receive 160 mg of enzalutamide in open-label period orally once a day until PSA progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer (up to 54.3 months). This arm represents both double blind and open-label period.
Placebo
Participants received enzalutamide matching placebo orally once a day during double-blind period until PSA progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer (up to 18.6 months). This arm represents only double blind period.
Placebo Followed by Enzalutamide
Eligible participants who received enzalutamide matching placebo during double-blind period and who provided consent to take part in open-label period, received 160 mg of enzalutamide orally once a day during open-label period until PSA progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer (up to 53.8 months). This arm represents only open-label period.
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 | 202 |
|---|
| Placebo | 193 |
|---|
| Placebo Followed by Enzalutamide | 51 |
|---|
Reported measurements
Treatment Emergent Adverse Events (TEAEs)
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Enzalutamide | 190 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo | 166 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo Followed by Enzalutamide | 47 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 3 or Higher TEAE
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Enzalutamide | 98 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo | 66 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo Followed by Enzalutamide | 28 | Not reported | Not reported | Not reported | Not reported |
|---|
TEAE Leading to Death
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Enzalutamide | 24 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo | 7 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo Followed by Enzalutamide | 7 | Not reported | Not reported | Not reported | Not reported |
|---|
Serious TEAE
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Enzalutamide | 87 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo | 57 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo Followed by Enzalutamide | 24 | Not reported | Not reported | Not reported | Not reported |
|---|
TEAE That Was Primary Reason for Treatment Discontinuation
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Enzalutamide | 32 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo | 33 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo Followed by Enzalutamide | 7 | Not reported | Not reported | Not reported | Not reported |
|---|
TEAE Leading to Study Drug Discontinuation
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Enzalutamide | 49 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo | 42 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo Followed by Enzalutamide | 12 | Not reported | Not reported | Not reported | Not reported |
|---|
TEAE Leading to Dose Reduction of Study Drug
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Enzalutamide | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo Followed by Enzalutamide | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
TEAE Leading to Dose Interruption of Study Drug
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Enzalutamide | 28 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo | 16 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo Followed by Enzalutamide | 7 | Not reported | Not reported | Not reported | Not reported |
|---|
TEAE Related to Study Drug
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Enzalutamide | 102 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo | 59 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo Followed by Enzalutamide | 13 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 3 or Higher TEAE Related to Study Drug
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Enzalutamide | 26 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo | 13 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo Followed by Enzalutamide | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
Serious TEAE Related to Study Drug
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Enzalutamide | 14 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo | 7 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo Followed by Enzalutamide | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 190
- group Id
- OG001
- value
- 166
- group Id
- OG002
- value
- 47
- title
- Treatment Emergent Adverse Events (TEAEs)
- categories
- measurements
- group Id
- OG000
- value
- 98
- group Id
- OG001
- value
- 66
- group Id
- OG002
- value
- 28
- title
- Grade 3 or Higher TEAE
- categories
- measurements
- group Id
- OG000
- value
- 24
- group Id
- OG001
- value
- 7
- group Id
- OG002
- value
- 7
- title
- TEAE Leading to Death
- categories
- measurements
- group Id
- OG000
- value
- 87
- group Id
- OG001
- value
- 57
- group Id
- OG002
- value
- 24
- title
- Serious TEAE
- categories
- measurements
- group Id
- OG000
- value
- 32
- group Id
- OG001
- value
- 33
- group Id
- OG002
- value
- 7
- title
- TEAE That Was Primary Reason for Treatment Discontinuation
- categories
- measurements
- group Id
- OG000
- value
- 49
- group Id
- OG001
- value
- 42
- group Id
- OG002
- value
- 12
- title
- TEAE Leading to Study Drug Discontinuation
- categories
- measurements
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 2
- title
- TEAE Leading to Dose Reduction of Study Drug
- categories
- measurements
- group Id
- OG000
- value
- 28
- group Id
- OG001
- value
- 16
- group Id
- OG002
- value
- 7
- title
- TEAE Leading to Dose Interruption of Study Drug
- categories
- measurements
- group Id
- OG000
- value
- 102
- group Id
- OG001
- value
- 59
- group Id
- OG002
- value
- 13
- title
- TEAE Related to Study Drug
- categories
- measurements
- group Id
- OG000
- value
- 26
- group Id
- OG001
- value
- 13
- group Id
- OG002
- value
- 5
- title
- Grade 3 or Higher TEAE Related to Study Drug
- categories
- measurements
- group Id
- OG000
- value
- 14
- group Id
- OG001
- value
- 7
- group Id
- OG002
- value
- 3
- title
- Serious TEAE Related to Study Drug
- denoms
- counts
- group Id
- OG000
- value
- 202
- group Id
- OG001
- value
- 193
- group Id
- OG002
- value
- 51
- units
- Participants
- description
- An AE was defined as any untoward medical occurrence, temporally associated with use of medicinal product, whether considered related to medicinal product. AE could therefore be any unfavorable \& unintended sign, symptom, or disease temporally associated with use of a medicinal product. An AE was considered serious if, results in death; is life-threatening; results in persistent disability; results in congenital anomaly; requires inpatient hospitalization; or leads to prolongation of hospitalization; other medically important events. TEAE was defined as AE occurring from time of study drug administration on Day 1 until follow-up visit (28 days after last dose, or one day before date of initiation of cytotoxic chemotherapy or an investigational agent, whichever comes first). AEs were graded using National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03, where Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Life-threatening; Grade 5 = Fatal.
- groups
- description
- Participants received 160 mg of enzalutamide orally once a day during double blind period until PSA progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer (up to 29.4 months). Eligible participants who received enzalutamide during double blind and who provided consent to take part in open-label period continued to receive 160 mg of enzalutamide in open-label period orally once a day until PSA progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer (up to 54.3 months). This arm represents both double blind and open-label period.
- id
- OG000
- title
- Enzalutamide
- description
- Participants received enzalutamide matching placebo orally once a day during double-blind period until PSA progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer (up to 18.6 months). This arm represents only double blind period.
- id
- OG001
- title
- Placebo
- description
- Eligible participants who received enzalutamide matching placebo during double-blind period and who provided consent to take part in open-label period, received 160 mg of enzalutamide orally once a day during open-label period until PSA progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer (up to 53.8 months). This arm represents only open-label period.
- id
- OG002
- title
- Placebo Followed by Enzalutamide
- param Type
- NUMBER
- population Description
- Safety Analysis Set consisted of all randomized participants who received at least 1 dose of study drug.
- reporting Status
- POSTED
- time Frame
- From first dose on Day 1 until 28 days after the last dose of study drug, or one day before the date of initiation of cytotoxic chemotherapy or an investigational agent for treatment of prostate cancer, whichever comes first, up to 123 months and 24 days
- title
- Number of Participants With Adverse Events (AE)
- type
- SECONDARY
- unit Of Measure
- Participants
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