TriangleNCT03277105 · OUTCOME
Time to Complete Response (CR) or Better
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- Interval / dispersion
- Full Range
- Time frame
- Up to 3 years
What was measured
Time to CR or better was defined as the time from randomization until onset of first CR or better.
Analysis population: Participants analyzed included responders (CR or better) in ITT analysis set. Here, 'N' (number of participants analysed) signifies participants who were evaluable for this outcome measure.
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 | 14 |
| Daratumumab SC | 12 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Daratumumab IV | 7.23 | Not reported | 1.1 | 14.9 | Not reported |
| Daratumumab SC | 9.26 | Not reported | 1.2 | 23.1 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.1
- upper Limit
- 14.9
- value
- 7.23
- group Id
- OG001
- lower Limit
- 1.2
- upper Limit
- 23.1
- value
- 9.26
- denoms
- counts
- group Id
- OG000
- value
- 14
- group Id
- OG001
- value
- 12
- units
- Participants
- description
- Time to CR or better was defined as the time from randomization until onset of first CR or better.
- dispersion Type
- Full Range
- 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
- Participants analyzed included responders (CR or better) in ITT analysis set. Here, 'N' (number of participants analysed) signifies participants who were evaluable for this outcome measure.
- reporting Status
- POSTED
- time Frame
- Up to 3 years
- title
- Time to Complete Response (CR) or Better
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice