TriangleNCT01950364 · OUTCOME
Number of Participants With Clinically Significant Change From Baseline in Vital Signs
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
- Baseline up to 30 days after last dose of study drug (30 Days after Cycle 16)
What was measured
Vital signs included body temperature, body weight, blood pressure and heart rate.
Analysis population: Safety analysis set included all participants who received at least 1 dose of study drug.
Groups in this outcome
Brentuximab Vedotin
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
Brentuximab Vedotin + Rifampicin
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
| Group | Source count |
|---|---|
| Brentuximab Vedotin | 10 |
| Brentuximab Vedotin + Rifampicin | 10 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Brentuximab Vedotin | 1 | Not reported | Not reported | Not reported | Not reported |
| Brentuximab Vedotin + Rifampicin | 2 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 2
- denoms
- counts
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 10
- units
- Participants
- description
- Vital signs included body temperature, body weight, blood pressure and heart rate.
- groups
- description
- Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
- id
- OG000
- title
- Brentuximab Vedotin
- description
- Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
- id
- OG001
- title
- Brentuximab Vedotin + Rifampicin
- param Type
- NUMBER
- population Description
- Safety analysis set included all participants who received at least 1 dose of study drug.
- reporting Status
- POSTED
- time Frame
- Baseline up to 30 days after last dose of study drug (30 Days after Cycle 16)
- title
- Number of Participants With Clinically Significant Change From Baseline in Vital Signs
- type
- SECONDARY
- unit Of Measure
- participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice