TriangleNCT03277105 · OUTCOME
Percentage of Participants With Treatment-emergent Infusion-related Reactions (IRR)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Up to 3 years
What was measured
Percentage of participants with treatment-emergent infusion-related reactions were reported.
Analysis population: Safety population included all randomized participants who received at least 1 dose of study drug.
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 | 258 |
| Daratumumab SC | 260 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Daratumumab IV | 34.5 | Not reported | 28.7 | 40.6 | Not reported |
| Daratumumab SC | 12.7 | Not reported | 8.9 | 17.4 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 28.7
- upper Limit
- 40.6
- value
- 34.5
- group Id
- OG001
- lower Limit
- 8.9
- upper Limit
- 17.4
- value
- 12.7
- denoms
- counts
- group Id
- OG000
- value
- 258
- group Id
- OG001
- value
- 260
- units
- Participants
- description
- Percentage of participants with treatment-emergent infusion-related reactions were reported.
- 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
- NUMBER
- population Description
- Safety population included all randomized participants who received at least 1 dose of study drug.
- reporting Status
- POSTED
- time Frame
- Up to 3 years
- title
- Percentage of Participants With Treatment-emergent Infusion-related Reactions (IRR)
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice