TriangleNCT03277105 · 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 3 years
What was measured
OS was defined as the time from the date of randomization to the date of the participant's death due to any cause.
Analysis population: ITT population included all the randomized participants.
Groups in this outcome
Daratumumab IV
Participants received daratumumab intravenous infusion (Dara IV) 16 milligrams per kilogram (mg/kg) once weekly in Cycle 1 and 2, every 2 weeks in Cycle 3 to 6, every 4 weeks thereafter until disease progression, unacceptable toxicity, withdrawal of consent, the investigator decides to stop treatment, or the start of subsequent anticancer therapy. The duration for each cycle was 28 days.
Daratumumab SC
Participants received daratumumab 1800 mg subcutaneous injection (Dara SC) co-formulated with recombinant human hyaluronidase (rHuPH20) 2000 Units per milliliter (U/mL), once weekly in Cycle 1 and 2, every 2 weeks in Cycle 3 to 6, every 4 weeks thereafter until disease progression, unacceptable toxicity, withdrawal of consent, the investigator decides to stop treatment, or the start of subsequent anticancer therapy. The duration for each cycle was 28 days.
| Group | Source count |
|---|---|
| Daratumumab IV | 259 |
| Daratumumab SC | 263 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Daratumumab IV | 25.56 | Not reported | 22.05 | NA | Lower limit of 95% CI were not estimable due to insufficient number of events. |
| Daratumumab SC | 28.19 | Not reported | 22.77 | NA | Lower limit of 95% CI were not estimable due to insufficient number of events. |
Complete source fields
- classes
- categories
- measurements
- comment
- Lower limit of 95% CI were not estimable due to insufficient number of events.
- group Id
- OG000
- lower Limit
- 22.05
- upper Limit
- NA
- value
- 25.56
- comment
- Lower limit of 95% CI were not estimable due to insufficient number of events.
- group Id
- OG001
- lower Limit
- 22.77
- upper Limit
- NA
- value
- 28.19
- denoms
- counts
- group Id
- OG000
- value
- 259
- group Id
- OG001
- value
- 263
- units
- Participants
- description
- OS was defined as the time from the date of randomization to the date of the participant's death due to any cause.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received daratumumab intravenous infusion (Dara IV) 16 milligrams per kilogram (mg/kg) once weekly in Cycle 1 and 2, every 2 weeks in Cycle 3 to 6, every 4 weeks thereafter until disease progression, unacceptable toxicity, withdrawal of consent, the investigator decides to stop treatment, or the start of subsequent anticancer therapy. The duration for each cycle was 28 days.
- id
- OG000
- title
- Daratumumab IV
- description
- Participants received daratumumab 1800 mg subcutaneous injection (Dara SC) co-formulated with recombinant human hyaluronidase (rHuPH20) 2000 Units per milliliter (U/mL), once weekly in Cycle 1 and 2, every 2 weeks in Cycle 3 to 6, every 4 weeks thereafter until disease progression, unacceptable toxicity, withdrawal of consent, the investigator decides to stop treatment, or the start of subsequent anticancer therapy. The duration for each cycle was 28 days.
- id
- OG001
- title
- Daratumumab SC
- param Type
- MEDIAN
- population Description
- ITT population included all the randomized participants.
- reporting Status
- POSTED
- time Frame
- Up to 3 years
- title
- Overall Survival (OS)
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice