TriangleNCT03277105 · OUTCOME
Maximum Trough Concentration (Ctrough) of Daratumumab
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- micrograms per milliliter (mcg/mL)
- Interval / dispersion
- Standard Deviation
- Time frame
- Predose on Cycle 3 Day 1 (each cycle of 28 days)
What was measured
Maximum Ctrough was defined as the serum predose concentration of daratumumab on Cycle 3 Day 1.
Analysis population: Pharmacokinetics (PK) population included participants who received at least 1 administration of study drug and had at least 1 PK sample concentration value after the first dose administration. Here, 'N' (number of participants analyzed) signifies number of participants 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 | 150 |
| Daratumumab SC | 157 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Daratumumab IV | 525 | 227 | Not reported | Not reported | Not reported |
| Daratumumab SC | 611 | 318 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 227
- value
- 525
- group Id
- OG001
- spread
- 318
- value
- 611
- denoms
- counts
- group Id
- OG000
- value
- 150
- group Id
- OG001
- value
- 157
- units
- Participants
- description
- Maximum Ctrough was defined as the serum predose concentration of daratumumab on Cycle 3 Day 1.
- dispersion Type
- Standard Deviation
- 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
- MEAN
- population Description
- Pharmacokinetics (PK) population included participants who received at least 1 administration of study drug and had at least 1 PK sample concentration value after the first dose administration. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.
- reporting Status
- POSTED
- time Frame
- Predose on Cycle 3 Day 1 (each cycle of 28 days)
- title
- Maximum Trough Concentration (Ctrough) of Daratumumab
- type
- PRIMARY
- unit Of Measure
- micrograms per milliliter (mcg/mL)
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice