TriangleNCT01380106 · OUTCOME
Serious Adverse Events
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Events
- Interval / dispersion
- Not reported
- Time frame
- Data was collected for each subject for the duration of the participation in the study, ranging between 75 to 475 days.
What was measured
Type, frequency, severity and timing of adverse events and their relationship to combination therapy with lenalidomide plus dexamethasone. SAE Grade 3 indicates a severe or medically significant but not immediately life threatening; hospitalization or prolongation of hospitalization; disabling; limiting self care ADL SAE Grade 4 indicates a life-threatening consequences; urgent intervention indicated. SAE Grade 5 Death related to AE.
Analysis population: 33
Groups in this outcome
Lenalidomide 25mg
Subjects will receive oral lenalidomide 25mg once daily for days 1-21 out of a 28 cycle Lenalidomide 25mg: Subjects will receive oral lenalidomide 25mg once daily for days 1-21 out of a 28 cycle
Lenalidomide 15mg
Subjects will receive oral lenalidomide 15mg once daily for days 1-21 out of a 28 cycle Lenalidomide 15mg: Subjects will receive oral lenalidomide 15 mg once daily for 1-21 of a 28 day cycle.
| Group | Source count |
|---|---|
| Lenalidomide 25mg | 16 |
| Lenalidomide 15mg | 17 |
Reported measurements
SAE Grade 3
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Lenalidomide 25mg | 23 | Not reported | Not reported | Not reported | Not reported |
| Lenalidomide 15mg | 23 | Not reported | Not reported | Not reported | Not reported |
SAE Grade 4
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Lenalidomide 25mg | 4 | Not reported | Not reported | Not reported | Not reported |
| Lenalidomide 15mg | 1 | Not reported | Not reported | Not reported | Not reported |
SAE Grade 5
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Lenalidomide 25mg | 1 | Not reported | Not reported | Not reported | Not reported |
| Lenalidomide 15mg | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 23
- group Id
- OG001
- value
- 23
- title
- SAE Grade 3
- categories
- measurements
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 1
- title
- SAE Grade 4
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- title
- SAE Grade 5
- denoms
- counts
- group Id
- OG000
- value
- 16
- group Id
- OG001
- value
- 17
- units
- Participants
- description
- Type, frequency, severity and timing of adverse events and their relationship to combination therapy with lenalidomide plus dexamethasone. SAE Grade 3 indicates a severe or medically significant but not immediately life threatening; hospitalization or prolongation of hospitalization; disabling; limiting self care ADL SAE Grade 4 indicates a life-threatening consequences; urgent intervention indicated. SAE Grade 5 Death related to AE.
- groups
- description
- Subjects will receive oral lenalidomide 25mg once daily for days 1-21 out of a 28 cycle Lenalidomide 25mg: Subjects will receive oral lenalidomide 25mg once daily for days 1-21 out of a 28 cycle
- id
- OG000
- title
- Lenalidomide 25mg
- description
- Subjects will receive oral lenalidomide 15mg once daily for days 1-21 out of a 28 cycle Lenalidomide 15mg: Subjects will receive oral lenalidomide 15 mg once daily for 1-21 of a 28 day cycle.
- id
- OG001
- title
- Lenalidomide 15mg
- param Type
- NUMBER
- population Description
- 33
- reporting Status
- POSTED
- time Frame
- Data was collected for each subject for the duration of the participation in the study, ranging between 75 to 475 days.
- title
- Serious Adverse Events
- type
- PRIMARY
- unit Of Measure
- Events
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice