TriangleNCT02375555 · OUTCOME
Grade 3 and 4 Treatment-Emergent Adverse Event (TEAE) Rate
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- proportion of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- The adverse event observation period defined as the time on treatment (+30d) is 278 weeks.
What was measured
Grade 3 and 4 TEA rate was defined as the proportion of participants who experienced a grade 3 or 4 adverse event of any attribution based on NCI Common Toxicity Criteria for Adverse Events Version 4 (CTCAEv4) on treatment.
Analysis population: All participants in the safety population.
Groups in this outcome
Elotuzumab, Lenalidomide, Bortezomib, and Dexamethasone
Participants will receive therapy with the combination of lenalidomide, bortezomib, and dexamethasone and elotuzumab (E-RVD). Induction cycles (1 to 8) are 21-day cycles. * Elotuzumab will be administered by intravenous (IV) infusion * Bortezomib as a subcutaneous injection * Lenalidomide single daily oral dose * Dexamethasone as oral tablets and IV infusion * Stem cell mobilization will be performed for all subjects at the end of Cycle 4. Subjects may elect to stop E-RVD at the end of Cycle 4 and proceed to autologous SCT. Subjects who do not proceed to SCT may receive 8 cycles of induction therapy. The maintenance schedule (28 days) will start after 8 cycles of induction regimen for subjects not proceeding with SCT, or after recovery from SCT for subjects proceeding with it. Maintenance therapy with E-RVD will be administered to all patients, with the specific maintenance regimen determined by risk category.
| Group | Source count |
|---|---|
| Elotuzumab, Lenalidomide, Bortezomib, and Dexamethasone | 40 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Elotuzumab, Lenalidomide, Bortezomib, and Dexamethasone | 0.70 | Not reported | 0.53 | 0.83 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.53
- upper Limit
- 0.83
- value
- 0.70
- denoms
- counts
- group Id
- OG000
- value
- 40
- units
- Participants
- description
- Grade 3 and 4 TEA rate was defined as the proportion of participants who experienced a grade 3 or 4 adverse event of any attribution based on NCI Common Toxicity Criteria for Adverse Events Version 4 (CTCAEv4) on treatment.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants will receive therapy with the combination of lenalidomide, bortezomib, and dexamethasone and elotuzumab (E-RVD). Induction cycles (1 to 8) are 21-day cycles. * Elotuzumab will be administered by intravenous (IV) infusion * Bortezomib as a subcutaneous injection * Lenalidomide single daily oral dose * Dexamethasone as oral tablets and IV infusion * Stem cell mobilization will be performed for all subjects at the end of Cycle 4. Subjects may elect to stop E-RVD at the end of Cycle 4 and proceed to autologous SCT. Subjects who do not proceed to SCT may receive 8 cycles of induction therapy. The maintenance schedule (28 days) will start after 8 cycles of induction regimen for subjects not proceeding with SCT, or after recovery from SCT for subjects proceeding with it. Maintenance therapy with E-RVD will be administered to all patients, with the specific maintenance regimen determined by risk category.
- id
- OG000
- title
- Elotuzumab, Lenalidomide, Bortezomib, and Dexamethasone
- param Type
- NUMBER
- population Description
- All participants in the safety population.
- reporting Status
- POSTED
- time Frame
- The adverse event observation period defined as the time on treatment (+30d) is 278 weeks.
- title
- Grade 3 and 4 Treatment-Emergent Adverse Event (TEAE) Rate
- type
- SECONDARY
- unit Of Measure
- proportion of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice