TriangleNCT03169361 · OUTCOME
Number of Participants Who Had One or More Adverse Drug Reactions (ADRs)
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. Adverse drug reaction (ADR) refers to AE related to administered drug.
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 | 573 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- calculate Pct
- false
- classes
- categories
- measurements
- group Id
- OG000
- value
- 573
- 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. Adverse drug reaction (ADR) refers to AE related to administered drug.
- 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 Who Had One or More Adverse Drug Reactions (ADRs)
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice