TriangleNCT01288911 · OUTCOME
Percentage of Participants With Adverse Events
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
- From initiation of study drug up to 30 days after last dose of study drug or the 30-day safety follow-up visit, whichever was last (Median duration of treatment was 11.6 months in enzalutamide arm and 5.8 in bicalutamide arm, 12.6 in the total arm).
What was measured
A serious adverse event was defined as any untoward medical occurrence that at any dose: ● Resulted in death ● Was life threatening ● Resulted in persistent or significant disability/incapacity ● Resulted in congenital anomaly or birth defect ● Required inpatient hospitalization or led to prolongation of hospitalization ● Other medically important events. Treatment-related indicates adverse events assessed by the Investigator as probably or possibly related to study treatment. Treatment emergent adverse events (TEAEs) were defined as adverse events (AEs) that started or worsened after starting administration of study drug through end of the study (i.e., the treatment-emergent period).
Analysis population: Safety Analysis Set (all participants who had initiated at least 1 dose of study drug)
Groups in this outcome
Enzalutamide
Participants received enzalutamide 160 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
Bicalutamide
Participants received bicalutamide 50 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
Total Enzalutamide
Participants received enzalutamide in the double-blind and/or open-label period (including participants who switched from bicalutamide to enzalutamide).
| Group | Source count |
|---|---|
| Enzalutamide | 183 |
| Bicalutamide | 189 |
| Total Enzalutamide | 192 |
Reported measurements
TEAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Enzalutamide | 94.5 | Not reported | Not reported | Not reported | Not reported |
| Bicalutamide | 94.2 | Not reported | Not reported | Not reported | Not reported |
| Total Enzalutamide | 94.8 | Not reported | Not reported | Not reported | Not reported |
Related TEAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Enzalutamide | 66.7 | Not reported | Not reported | Not reported | Not reported |
| Bicalutamide | 49.7 | Not reported | Not reported | Not reported | Not reported |
| Total Enzalutamide | 67.2 | Not reported | Not reported | Not reported | Not reported |
Deaths
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Enzalutamide | 5.5 | Not reported | Not reported | Not reported | Not reported |
| Bicalutamide | 1.6 | Not reported | Not reported | Not reported | Not reported |
| Total Enzalutamide | 5.7 | Not reported | Not reported | Not reported | Not reported |
Serious TEAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Enzalutamide | 33.3 | Not reported | Not reported | Not reported | Not reported |
| Bicalutamide | 23.8 | Not reported | Not reported | Not reported | Not reported |
| Total Enzalutamide | 36.5 | Not reported | Not reported | Not reported | Not reported |
Drug regimen-related serious TEAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Enzalutamide | 6.6 | Not reported | Not reported | Not reported | Not reported |
| Bicalutamide | 3.2 | Not reported | Not reported | Not reported | Not reported |
| Total Enzalutamide | 6.8 | Not reported | Not reported | Not reported | Not reported |
TEAEs leading to discontinuation
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Enzalutamide | 29.5 | Not reported | Not reported | Not reported | Not reported |
| Bicalutamide | 23.8 | Not reported | Not reported | Not reported | Not reported |
| Total Enzalutamide | 31.3 | Not reported | Not reported | Not reported | Not reported |
Drug regimen-related TEAEs leading to discon.
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Enzalutamide | 7.7 | Not reported | Not reported | Not reported | Not reported |
| Bicalutamide | 5.3 | Not reported | Not reported | Not reported | Not reported |
| Total Enzalutamide | 7.8 | Not reported | Not reported | Not reported | Not reported |
TEAEs leading to study drug interruption
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Enzalutamide | 10.4 | Not reported | Not reported | Not reported | Not reported |
| Bicalutamide | 7.9 | Not reported | Not reported | Not reported | Not reported |
| Total Enzalutamide | 10.4 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 94.5
- group Id
- OG001
- value
- 94.2
- group Id
- OG002
- value
- 94.8
- title
- TEAEs
- categories
- measurements
- group Id
- OG000
- value
- 66.7
- group Id
- OG001
- value
- 49.7
- group Id
- OG002
- value
- 67.2
- title
- Related TEAEs
- categories
- measurements
- group Id
- OG000
- value
- 5.5
- group Id
- OG001
- value
- 1.6
- group Id
- OG002
- value
- 5.7
- title
- Deaths
- categories
- measurements
- group Id
- OG000
- value
- 33.3
- group Id
- OG001
- value
- 23.8
- group Id
- OG002
- value
- 36.5
- title
- Serious TEAEs
- categories
- measurements
- group Id
- OG000
- value
- 6.6
- group Id
- OG001
- value
- 3.2
- group Id
- OG002
- value
- 6.8
- title
- Drug regimen-related serious TEAEs
- categories
- measurements
- group Id
- OG000
- value
- 29.5
- group Id
- OG001
- value
- 23.8
- group Id
- OG002
- value
- 31.3
- title
- TEAEs leading to discontinuation
- categories
- measurements
- group Id
- OG000
- value
- 7.7
- group Id
- OG001
- value
- 5.3
- group Id
- OG002
- value
- 7.8
- title
- Drug regimen-related TEAEs leading to discon.
- categories
- measurements
- group Id
- OG000
- value
- 10.4
- group Id
- OG001
- value
- 7.9
- group Id
- OG002
- value
- 10.4
- title
- TEAEs leading to study drug interruption
- denoms
- counts
- group Id
- OG000
- value
- 183
- group Id
- OG001
- value
- 189
- group Id
- OG002
- value
- 192
- units
- Participants
- description
- A serious adverse event was defined as any untoward medical occurrence that at any dose: ● Resulted in death ● Was life threatening ● Resulted in persistent or significant disability/incapacity ● Resulted in congenital anomaly or birth defect ● Required inpatient hospitalization or led to prolongation of hospitalization ● Other medically important events. Treatment-related indicates adverse events assessed by the Investigator as probably or possibly related to study treatment. Treatment emergent adverse events (TEAEs) were defined as adverse events (AEs) that started or worsened after starting administration of study drug through end of the study (i.e., the treatment-emergent period).
- groups
- description
- Participants received enzalutamide 160 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
- id
- OG000
- title
- Enzalutamide
- description
- Participants received bicalutamide 50 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
- id
- OG001
- title
- Bicalutamide
- description
- Participants received enzalutamide in the double-blind and/or open-label period (including participants who switched from bicalutamide to enzalutamide).
- id
- OG002
- title
- Total Enzalutamide
- param Type
- NUMBER
- population Description
- Safety Analysis Set (all participants who had initiated at least 1 dose of study drug)
- reporting Status
- POSTED
- time Frame
- From initiation of study drug up to 30 days after last dose of study drug or the 30-day safety follow-up visit, whichever was last (Median duration of treatment was 11.6 months in enzalutamide arm and 5.8 in bicalutamide arm, 12.6 in the total arm).
- title
- Percentage of Participants With Adverse Events
- type
- SECONDARY
- unit Of Measure
- percentage of participants
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Preserved source evidence · Not medical advice