TriangleNCT02136134 · OUTCOME
Overall Survival (OS)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Up to 6 years 9 months
What was measured
Overall Survival was measured from the date of randomization to the date of the participant's death.
Analysis population: The intent-to-treat (ITT) population included all randomized participants.
Groups in this outcome
Bortezomib + Dexamethasone (Vd)
Participants received bortezomib 1.3 milligrams per square meter (mg/m\^2) subcutaneous (SC) injection on Days 1, 4, 8, and 11 of each 21-day cycle (8 treatment cycles) and dexamethasone 20 milligrams (mg) orally (PO) on Days 1, 2, 4, 5, 8, 9, 11, and 12 of the first 8 bortezomib treatment cycles. Participants who met sponsor-confirmed disease progression eligibility criteria received daratumumab monotherapy as a subsequent antimyeloma therapy as follow: daratumumab 16 milligrams per kilogram (mg/kg) intravenous (IV) infusion or daratumumab SC injection (1800 mg fixed dose) weekly for the first 2 cycles, every 2 weeks from Cycle 3 to 6, and then every 4 weeks thereafter.
Daratumumab + Bortezomib and Dexamethasone (DVd)
Participants received daratumumab 16 mg/kg IV infusion weekly or daratumumab SC injection (1800 mg fixed dose) for the first 3 cycles, on Day 1 of Cycles 4-8, and then every 4 weeks thereafter, bortezomib 1.3 mg/m\^2 SC injection administration on Days 1, 4, 8, and 11 of each 21-day cycle (8 treatment cycles) and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11, and 12 of the first 8 bortezomib treatment cycles.
| Group | Source count |
|---|---|
| Bortezomib + Dexamethasone (Vd) | 247 |
| Daratumumab + Bortezomib and Dexamethasone (DVd) | 251 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Bortezomib + Dexamethasone (Vd) | 38.51 | Not reported | 31.18 | 46.23 | Not reported |
| Daratumumab + Bortezomib and Dexamethasone (DVd) | 49.58 | Not reported | 42.18 | 62.32 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 31.18
- upper Limit
- 46.23
- value
- 38.51
- group Id
- OG001
- lower Limit
- 42.18
- upper Limit
- 62.32
- value
- 49.58
- denoms
- counts
- group Id
- OG000
- value
- 247
- group Id
- OG001
- value
- 251
- units
- Participants
- description
- Overall Survival was measured from the date of randomization to the date of the participant's death.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received bortezomib 1.3 milligrams per square meter (mg/m\^2) subcutaneous (SC) injection on Days 1, 4, 8, and 11 of each 21-day cycle (8 treatment cycles) and dexamethasone 20 milligrams (mg) orally (PO) on Days 1, 2, 4, 5, 8, 9, 11, and 12 of the first 8 bortezomib treatment cycles. Participants who met sponsor-confirmed disease progression eligibility criteria received daratumumab monotherapy as a subsequent antimyeloma therapy as follow: daratumumab 16 milligrams per kilogram (mg/kg) intravenous (IV) infusion or daratumumab SC injection (1800 mg fixed dose) weekly for the first 2 cycles, every 2 weeks from Cycle 3 to 6, and then every 4 weeks thereafter.
- id
- OG000
- title
- Bortezomib + Dexamethasone (Vd)
- description
- Participants received daratumumab 16 mg/kg IV infusion weekly or daratumumab SC injection (1800 mg fixed dose) for the first 3 cycles, on Day 1 of Cycles 4-8, and then every 4 weeks thereafter, bortezomib 1.3 mg/m\^2 SC injection administration on Days 1, 4, 8, and 11 of each 21-day cycle (8 treatment cycles) and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11, and 12 of the first 8 bortezomib treatment cycles.
- id
- OG001
- title
- Daratumumab + Bortezomib and Dexamethasone (DVd)
- param Type
- MEDIAN
- population Description
- The intent-to-treat (ITT) population included all randomized participants.
- reporting Status
- POSTED
- time Frame
- Up to 6 years 9 months
- title
- Overall Survival (OS)
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice