TriangleNCT01482962 · OUTCOME
Number of Participants With Clinically Important Vital Sign Measurements Reported as AEs
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
- First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks)
What was measured
Vital signs included blood pressure, heart rate and temperature. Individual clinically significant changes in vital signs were reported by the investigator as TEAEs.
Analysis population: Safety population was defined as all participants who received at least 1 dose of alisertib, or one of the comparator drugs. Participants were analyzed according to the treatment actually received.
Groups in this outcome
Alisertib
Alisertib 50 mg, enteric-coated tablet formulation, orally, twice daily for 7 consecutive days (Cycle Days 1-7) in a 21-day cycle (Up to 148 Weeks).
Pralatrexate, or Romidepsin, or Gemcitabine
Pralatrexate 30 mg/m\^2, intravenous (IV) push over 3 to 5 minutes, once weekly, for 6 weeks in 7-week cycles with concurrent vitamin B12 and folic acid supplementation. Cycles were repeated every 7-weeks provided the participant continued to benefit from and tolerate the therapy (Up to 115 Weeks), or Gemcitabine 1,000 mg/m\^2 over 30 minutes, intravenously, on Days 1, 8, and 15 of a 28-day cycle until the absence of disease progression or unacceptable toxicity (Up to 32 Weeks), or Romidepsin 14 mg/m\^2, intravenously over a 4-hour period, on Days 1, 8, and 15 of a 28-cycle. Cycles were repeated every 28 days provided the patient continued to benefit from and tolerate the therapy (Up to 30 Weeks).
| Group | Source count |
|---|---|
| Alisertib | 137 |
| Pralatrexate, or Romidepsin, or Gemcitabine | 127 |
Reported measurements
Heart Rate Increased
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Alisertib | 1 | Not reported | Not reported | Not reported | Not reported |
| Pralatrexate, or Romidepsin, or Gemcitabine | 0 | Not reported | Not reported | Not reported | Not reported |
Body Temperature Increased
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Alisertib | 0 | Not reported | Not reported | Not reported | Not reported |
| Pralatrexate, or Romidepsin, or Gemcitabine | 1 | Not reported | Not reported | Not reported | Not reported |
Hypotension
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Alisertib | 4 | Not reported | Not reported | Not reported | Not reported |
| Pralatrexate, or Romidepsin, or Gemcitabine | 6 | Not reported | Not reported | Not reported | Not reported |
Orthostatic Hypotension
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Alisertib | 2 | Not reported | Not reported | Not reported | Not reported |
| Pralatrexate, or Romidepsin, or Gemcitabine | 1 | Not reported | Not reported | Not reported | Not reported |
Hypertension
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Alisertib | 5 | Not reported | Not reported | Not reported | Not reported |
| Pralatrexate, or Romidepsin, or Gemcitabine | 7 | Not reported | Not reported | Not reported | Not reported |
Pyrexia
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Alisertib | 48 | Not reported | Not reported | Not reported | Not reported |
| Pralatrexate, or Romidepsin, or Gemcitabine | 40 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- title
- Heart Rate Increased
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- title
- Body Temperature Increased
- categories
- measurements
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 6
- title
- Hypotension
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 1
- title
- Orthostatic Hypotension
- categories
- measurements
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 7
- title
- Hypertension
- categories
- measurements
- group Id
- OG000
- value
- 48
- group Id
- OG001
- value
- 40
- title
- Pyrexia
- denoms
- counts
- group Id
- OG000
- value
- 137
- group Id
- OG001
- value
- 127
- units
- Participants
- description
- Vital signs included blood pressure, heart rate and temperature. Individual clinically significant changes in vital signs were reported by the investigator as TEAEs.
- groups
- description
- Alisertib 50 mg, enteric-coated tablet formulation, orally, twice daily for 7 consecutive days (Cycle Days 1-7) in a 21-day cycle (Up to 148 Weeks).
- id
- OG000
- title
- Alisertib
- description
- Pralatrexate 30 mg/m\^2, intravenous (IV) push over 3 to 5 minutes, once weekly, for 6 weeks in 7-week cycles with concurrent vitamin B12 and folic acid supplementation. Cycles were repeated every 7-weeks provided the participant continued to benefit from and tolerate the therapy (Up to 115 Weeks), or Gemcitabine 1,000 mg/m\^2 over 30 minutes, intravenously, on Days 1, 8, and 15 of a 28-day cycle until the absence of disease progression or unacceptable toxicity (Up to 32 Weeks), or Romidepsin 14 mg/m\^2, intravenously over a 4-hour period, on Days 1, 8, and 15 of a 28-cycle. Cycles were repeated every 28 days provided the patient continued to benefit from and tolerate the therapy (Up to 30 Weeks).
- id
- OG001
- title
- Pralatrexate, or Romidepsin, or Gemcitabine
- param Type
- NUMBER
- population Description
- Safety population was defined as all participants who received at least 1 dose of alisertib, or one of the comparator drugs. Participants were analyzed according to the treatment actually received.
- reporting Status
- POSTED
- time Frame
- First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks)
- title
- Number of Participants With Clinically Important Vital Sign Measurements Reported as AEs
- type
- SECONDARY
- unit Of Measure
- participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice