TriangleNCT01492088 · OUTCOME
Number of Participants With Clinically Significant Vital Signs Values Reported as AEs (Phase 1)
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
- From the first dose through 30 days after the last dose of study medication (Up to 15 months)
What was measured
Vital signs measurements included supine (after 3-5 minutes in this position) and standing (after 3-5 minutes in this position) measurements of diastolic and systolic blood pressure, heart rate, and oral temperature.
Analysis population: Safety population is defined as all participants who received at least 1 dose of study drug. Participants enrolled in Phase 1 of study were evaluated for this outcome measure.
Groups in this outcome
Brentuximab Vedotin 1.4 mg/kg: Phase 1
Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
Brentuximab Vedotin 1.8 mg/kg: Phase 1
Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle starting from Cycle 2 until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
| Group | Source count |
|---|---|
| Brentuximab Vedotin 1.4 mg/kg: Phase 1 | 3 |
| Brentuximab Vedotin 1.8 mg/kg: Phase 1 | 9 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Brentuximab Vedotin 1.4 mg/kg: Phase 1 | 0 | Not reported | Not reported | Not reported | Not reported |
| Brentuximab Vedotin 1.8 mg/kg: Phase 1 | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 9
- units
- Participants
- description
- Vital signs measurements included supine (after 3-5 minutes in this position) and standing (after 3-5 minutes in this position) measurements of diastolic and systolic blood pressure, heart rate, and oral temperature.
- groups
- description
- Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
- id
- OG000
- title
- Brentuximab Vedotin 1.4 mg/kg: Phase 1
- description
- Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle starting from Cycle 2 until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
- id
- OG001
- title
- Brentuximab Vedotin 1.8 mg/kg: Phase 1
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Safety population is defined as all participants who received at least 1 dose of study drug. Participants enrolled in Phase 1 of study were evaluated for this outcome measure.
- reporting Status
- POSTED
- time Frame
- From the first dose through 30 days after the last dose of study medication (Up to 15 months)
- title
- Number of Participants With Clinically Significant Vital Signs Values Reported as AEs (Phase 1)
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice