TriangleNCT00974311 · OUTCOME
Number of Participants With Clinically Significant Changes in Vital Signs
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
Criteria for abnormalities in vital signs included: sitting/supine systolic blood pressure (SBP) values: absolute result greater than (\>) 180 millimeter of mercury (mmHg) and \>40 mmHg increase from baseline (BL) and less than (\<) 90 mmHg and \>30 mmHg decrease from BL; diastolic blood pressure (DBP) values: absolute result \>105 mmHg and \>30 mmHg increase from BL and absolute result \< 50 mmHg and \>20 mmHg decrease from BL; any abnormalities in SBP or DBP; heart rate values: absolute result \> 120 beats per minute (bpm) and \>30 bpm increase from BL and absolute result \< 50 bpm and \>20 bpm decrease from BL or any abnormalities in heart rate. 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 | Source count |
|---|---|
| Enzalutamide | 800 |
| Placebo: DB Phase | 399 |
| Placebo (DB) /Enzalutamide 160 mg (OLE) Phase | 50 |
Reported measurements
SBP: >180 mmHg and >40 mmHg Increase from BL
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Enzalutamide | 28 | Not reported | Not reported | Not reported | Not reported |
| Placebo: DB Phase | 7 | Not reported | Not reported | Not reported | Not reported |
| Placebo (DB) /Enzalutamide 160 mg (OLE) Phase | 1 | Not reported | Not reported | Not reported | Not reported |
SBP: < 90 mmHg and >30 mmHg Decrease from BL
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Enzalutamide | 13 | Not reported | Not reported | Not reported | Not reported |
| Placebo: DB Phase | 5 | Not reported | Not reported | Not reported | Not reported |
| Placebo (DB) /Enzalutamide 160 mg (OLE) Phase | 0 | Not reported | Not reported | Not reported | Not reported |
DBP: >105 mmHg and >30 mmHg Increase from BL
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Enzalutamide | 5 | 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 |
DBP: < 50 mmHg and >20 mmHg Decrease from BL
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Enzalutamide | 13 | 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 | 1 | Not reported | Not reported | Not reported | Not reported |
Any abnormalities in SBP or DBP
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Enzalutamide | 52 | Not reported | Not reported | Not reported | Not reported |
| Placebo: DB Phase | 16 | Not reported | Not reported | Not reported | Not reported |
| Placebo (DB) /Enzalutamide 160 mg (OLE) Phase | 2 | Not reported | Not reported | Not reported | Not reported |
Heart Rate: > 120 bpm and >30 bpm Increase from BL
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Enzalutamide | 7 | Not reported | Not reported | Not reported | Not reported |
| Placebo: DB Phase | 5 | Not reported | Not reported | Not reported | Not reported |
| Placebo (DB) /Enzalutamide 160 mg (OLE) Phase | 0 | Not reported | Not reported | Not reported | Not reported |
Heart Rate: < 50 bpm and >20 bpm Decrease from BL
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Enzalutamide | 18 | 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 |
Any abnormalities in Heart Rate
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Enzalutamide | 25 | Not reported | Not reported | Not reported | Not reported |
| Placebo: DB Phase | 6 | 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
- 28
- group Id
- OG001
- value
- 7
- group Id
- OG002
- value
- 1
- title
- SBP: >180 mmHg and >40 mmHg Increase from BL
- categories
- measurements
- group Id
- OG000
- value
- 13
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 0
- title
- SBP: < 90 mmHg and >30 mmHg Decrease from BL
- categories
- measurements
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 0
- title
- DBP: >105 mmHg and >30 mmHg Increase from BL
- categories
- measurements
- group Id
- OG000
- value
- 13
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 1
- title
- DBP: < 50 mmHg and >20 mmHg Decrease from BL
- categories
- measurements
- group Id
- OG000
- value
- 52
- group Id
- OG001
- value
- 16
- group Id
- OG002
- value
- 2
- title
- Any abnormalities in SBP or DBP
- categories
- measurements
- group Id
- OG000
- value
- 7
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 0
- title
- Heart Rate: > 120 bpm and >30 bpm Increase from BL
- categories
- measurements
- group Id
- OG000
- value
- 18
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 0
- title
- Heart Rate: < 50 bpm and >20 bpm Decrease from BL
- categories
- measurements
- group Id
- OG000
- value
- 25
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 0
- title
- Any abnormalities in Heart Rate
- denoms
- counts
- group Id
- OG000
- value
- 800
- group Id
- OG001
- value
- 399
- group Id
- OG002
- value
- 50
- units
- Participants
- description
- Criteria for abnormalities in vital signs included: sitting/supine systolic blood pressure (SBP) values: absolute result greater than (\>) 180 millimeter of mercury (mmHg) and \>40 mmHg increase from baseline (BL) and less than (\<) 90 mmHg and \>30 mmHg decrease from BL; diastolic blood pressure (DBP) values: absolute result \>105 mmHg and \>30 mmHg increase from BL and absolute result \< 50 mmHg and \>20 mmHg decrease from BL; any abnormalities in SBP or DBP; heart rate values: absolute result \> 120 beats per minute (bpm) and \>30 bpm increase from BL and absolute result \< 50 bpm and \>20 bpm decrease from BL or any abnormalities in heart rate. 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 Clinically Significant Changes in Vital Signs
- type
- OTHER_PRE_SPECIFIED
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice