TriangleNCT02312258 · OUTCOME
Time to Resolution of Peripheral Neuropathy (PN) Events
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- days
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Up to 52 months
What was measured
PN is defined as the event in the high-level term of peripheral neuropathies not elsewhere classified (NEC) according to the medical dictionary for regulatory activities (MedDRA). A PN event was considered as resolved if its final outcome was resolved with no subsequent PN event of the same preferred term occurring on the resolution date or the day before and after. Time to resolution was defined as the time from the initial onset date (inclusive) to the resolution date for resolved events.
Analysis population: Safety Population included all participants who received at least 1 dose of ixazomib or placebo. Overall number of participants analyzed are the number of participants with events.
Groups in this outcome
Placebo
Ixazomib 3 mg, capsule, orally, once on Days 1, 8, and 15 of each 28-day cycle from Cycles 1 through 26.
Ixazomib
Ixazomib 3 mg, capsule, orally, once on Days 1, 8, and 15 of each 28-day cycle from Cycles 1 to 4 that may have been escalated to 4 mg thereafter up to Cycle 26.
| Group | Source count |
|---|---|
| Placebo | 30 |
| Ixazomib | 83 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo | 196.0 | Not reported | 43.0 | 331.0 | Not reported |
| Ixazomib | 451.0 | Not reported | 98.0 | NA | Upper limit of CI was not estimable due to censoring. |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 43.0
- upper Limit
- 331.0
- value
- 196.0
- comment
- Upper limit of CI was not estimable due to censoring.
- group Id
- OG001
- lower Limit
- 98.0
- upper Limit
- NA
- value
- 451.0
- denoms
- counts
- group Id
- OG000
- value
- 30
- group Id
- OG001
- value
- 83
- units
- Participants
- description
- PN is defined as the event in the high-level term of peripheral neuropathies not elsewhere classified (NEC) according to the medical dictionary for regulatory activities (MedDRA). A PN event was considered as resolved if its final outcome was resolved with no subsequent PN event of the same preferred term occurring on the resolution date or the day before and after. Time to resolution was defined as the time from the initial onset date (inclusive) to the resolution date for resolved events.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Ixazomib 3 mg, capsule, orally, once on Days 1, 8, and 15 of each 28-day cycle from Cycles 1 through 26.
- id
- OG000
- title
- Placebo
- description
- Ixazomib 3 mg, capsule, orally, once on Days 1, 8, and 15 of each 28-day cycle from Cycles 1 to 4 that may have been escalated to 4 mg thereafter up to Cycle 26.
- id
- OG001
- title
- Ixazomib
- param Type
- MEDIAN
- population Description
- Safety Population included all participants who received at least 1 dose of ixazomib or placebo. Overall number of participants analyzed are the number of participants with events.
- reporting Status
- POSTED
- time Frame
- Up to 52 months
- title
- Time to Resolution of Peripheral Neuropathy (PN) Events
- type
- SECONDARY
- unit Of Measure
- days
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice