TriangleNCT04272775 · OUTCOME
Number of Participants With Grade 3 or Higher TEAE Related to Body Weight
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 29 days after last dose of study drug (up to Cycle 87 Day 44) (Each Cycle length=28 days)
What was measured
Body weight abnormalities were graded using the CTCAE version 4.03. as: Grade 1 (Mild, asymptomatic or mild symptoms); Grade 2 (Moderate, minimal, local or noninvasive intervention indicated); Grade 3 (Severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated); Grade 4 (Life-threatening consequences, urgent intervention indicated); Grade 5 (Death related to AE).
Analysis population: The safety analysis set consisted of all participants who received at least one dose of ixazomib.
Groups in this outcome
Cohort 1: Ixazomib 4.0 mg
Ixazomib 4.0 mg, capsules, orally, once, on Days 1, 8, and 15 in 28-day treatment cycle for up to Cycle 87.
Cohort 2: Ixazomib 4.0 mg + Lenalidomide and Dexamethasone
Ixazomib 4.0 mg, capsules, orally, once, on Days 1, 8, and 15 in 28-day treatment cycle along with lenalidomide 25 mg/day, capsules, orally, once, from Days 1 to 21 and dexamethasone 40 mg/day, tablets, orally, once, on Days 1, 8, 15, and 22 in a 28-day treatment cycle for up to Cycle 62.
| Group | Source count |
|---|---|
| Cohort 1: Ixazomib 4.0 mg | 7 |
| Cohort 2: Ixazomib 4.0 mg + Lenalidomide and Dexamethasone | 7 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1: Ixazomib 4.0 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2: Ixazomib 4.0 mg + Lenalidomide and Dexamethasone | 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
- 7
- group Id
- OG001
- value
- 7
- units
- Participants
- description
- Body weight abnormalities were graded using the CTCAE version 4.03. as: Grade 1 (Mild, asymptomatic or mild symptoms); Grade 2 (Moderate, minimal, local or noninvasive intervention indicated); Grade 3 (Severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated); Grade 4 (Life-threatening consequences, urgent intervention indicated); Grade 5 (Death related to AE).
- groups
- description
- Ixazomib 4.0 mg, capsules, orally, once, on Days 1, 8, and 15 in 28-day treatment cycle for up to Cycle 87.
- id
- OG000
- title
- Cohort 1: Ixazomib 4.0 mg
- description
- Ixazomib 4.0 mg, capsules, orally, once, on Days 1, 8, and 15 in 28-day treatment cycle along with lenalidomide 25 mg/day, capsules, orally, once, from Days 1 to 21 and dexamethasone 40 mg/day, tablets, orally, once, on Days 1, 8, 15, and 22 in a 28-day treatment cycle for up to Cycle 62.
- id
- OG001
- title
- Cohort 2: Ixazomib 4.0 mg + Lenalidomide and Dexamethasone
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- The safety analysis set consisted of all participants who received at least one dose of ixazomib.
- reporting Status
- POSTED
- time Frame
- Baseline up to 29 days after last dose of study drug (up to Cycle 87 Day 44) (Each Cycle length=28 days)
- title
- Number of Participants With Grade 3 or Higher TEAE Related to Body Weight
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice