TriangleNCT01645930 · OUTCOME
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- participants
- Interval / dispersion
- Not reported
- Time frame
- From the first dose of study drug through 30 days after the last dose of study drug (up to 577 days)
What was measured
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A SAE is defined as any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or was a medically important event.
Analysis population: Safety population was defined as all participants who received at least 1 dose of study drug.
Groups in this outcome
Ixazomib+Lenalidomide+Dexamethasone
Ixazomib 4 mg, capsules, orally, once on Days 1, 8, and 15; lenalidomide 25 mg, capsules, orally, once on Days 1 through 21; and dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15, and 22 of a 28-day treatment cycle until progressive disease (PD) or unacceptable toxicity (up to 20 cycles)
| Group | Source count |
|---|---|
| Ixazomib+Lenalidomide+Dexamethasone | 43 |
Reported measurements
AEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ixazomib+Lenalidomide+Dexamethasone | 43 | Not reported | Not reported | Not reported | Not reported |
SAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ixazomib+Lenalidomide+Dexamethasone | 18 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 43
- title
- AEs
- categories
- measurements
- group Id
- OG000
- value
- 18
- title
- SAEs
- denoms
- counts
- group Id
- OG000
- value
- 43
- units
- Participants
- description
- An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A SAE is defined as any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or was a medically important event.
- groups
- description
- Ixazomib 4 mg, capsules, orally, once on Days 1, 8, and 15; lenalidomide 25 mg, capsules, orally, once on Days 1 through 21; and dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15, and 22 of a 28-day treatment cycle until progressive disease (PD) or unacceptable toxicity (up to 20 cycles)
- id
- OG000
- title
- Ixazomib+Lenalidomide+Dexamethasone
- param Type
- NUMBER
- population Description
- Safety population was defined as all participants who received at least 1 dose of study drug.
- reporting Status
- POSTED
- time Frame
- From the first dose of study drug through 30 days after the last dose of study drug (up to 577 days)
- title
- Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
- type
- PRIMARY
- unit Of Measure
- participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice