TriangleNCT03457142 · OUTCOME
Incidence of Adverse Events Assessed Using National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
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
- Up to 30 days after last dose
What was measured
The adverse events and drug related toxicities will be summarized by grade using frequencies and relative frequencies. The rate of grade 3 or higher toxicities that are probably or definitely related to abatacept will be reported with 90% confidence intervals obtained using Jeffrey?s prior method.
Groups in this outcome
Treatment (Abatacept, Ixazomib Citrate, Dexamethasone)
Patients receive abatacept IV over 30 minutes on day 1 of course 1, then SC on days 2, 8, 15, and 22 of course 1, and then on days 1, 8, 15, and 22 of subsequent courses. Patients also receive ixazomib citrate PO QD on days 1, 8, and 15 and dexamethasone on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Abatacept: Given IV and SC Dexamethasone: Given PO Ixazomib Citrate: Given PO Laboratory Biomarker Analysis: Correlative studies
| Group | Source count |
|---|---|
| Treatment (Abatacept, Ixazomib Citrate, Dexamethasone) | 15 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Treatment (Abatacept, Ixazomib Citrate, Dexamethasone) | 5 | Not reported | Not reported | Not reported | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.17
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 90
- ci Upper Limit
- 0.54
- group Ids
- OG000
- non Inferiority Comment
- No formal test, a confidence interval estimate for the grade 3+ treatment related AE rate.
- non Inferiority Type
- OTHER
- param Type
- grade 3+ treatment related AE rate
- param Value
- 0.33
Complete source fields
- analyses
- ci Lower Limit
- 0.17
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 90
- ci Upper Limit
- 0.54
- group Ids
- OG000
- non Inferiority Comment
- No formal test, a confidence interval estimate for the grade 3+ treatment related AE rate.
- non Inferiority Type
- OTHER
- param Type
- grade 3+ treatment related AE rate
- param Value
- 0.33
- classes
- categories
- measurements
- group Id
- OG000
- value
- 5
- denoms
- counts
- group Id
- OG000
- value
- 15
- units
- Participants
- description
- The adverse events and drug related toxicities will be summarized by grade using frequencies and relative frequencies. The rate of grade 3 or higher toxicities that are probably or definitely related to abatacept will be reported with 90% confidence intervals obtained using Jeffrey?s prior method.
- groups
- description
- Patients receive abatacept IV over 30 minutes on day 1 of course 1, then SC on days 2, 8, 15, and 22 of course 1, and then on days 1, 8, 15, and 22 of subsequent courses. Patients also receive ixazomib citrate PO QD on days 1, 8, and 15 and dexamethasone on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Abatacept: Given IV and SC Dexamethasone: Given PO Ixazomib Citrate: Given PO Laboratory Biomarker Analysis: Correlative studies
- id
- OG000
- title
- Treatment (Abatacept, Ixazomib Citrate, Dexamethasone)
- param Type
- COUNT_OF_PARTICIPANTS
- reporting Status
- POSTED
- time Frame
- Up to 30 days after last dose
- title
- Incidence of Adverse Events Assessed Using National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice