TriangleNCT03169361 · OUTCOME
Number of Participants Reporting One or More Adverse Events (AEs)
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 24 Week (From start of administration to the end of 6 cycles)
What was measured
An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Analysis population: Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.
Groups in this outcome
Ixazomib 4 mg
The usual adult dosage for oral administration was 4 mg as ixazomib, in the fasting state, once a day, once a week for 3 weeks (Days 1, 8, and 15), with a 13-day washout period (Days 16 through 28). This 4-week cycle was repeated for 6 cycles. The dose might be reduced appropriately according to the patient's condition. Participants received interventions as part of routine medical care.
| Group | Source count |
|---|---|
| Ixazomib 4 mg | 742 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ixazomib 4 mg | 642 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- calculate Pct
- false
- classes
- categories
- measurements
- group Id
- OG000
- value
- 642
- denoms
- counts
- group Id
- OG000
- value
- 742
- units
- Participants
- description
- An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
- groups
- description
- The usual adult dosage for oral administration was 4 mg as ixazomib, in the fasting state, once a day, once a week for 3 weeks (Days 1, 8, and 15), with a 13-day washout period (Days 16 through 28). This 4-week cycle was repeated for 6 cycles. The dose might be reduced appropriately according to the patient's condition. Participants received interventions as part of routine medical care.
- id
- OG000
- title
- Ixazomib 4 mg
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.
- reporting Status
- POSTED
- time Frame
- Up to 24 Week (From start of administration to the end of 6 cycles)
- title
- Number of Participants Reporting One or More Adverse Events (AEs)
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice