TriangleNCT00574288 · OUTCOME
Number of Participants With Adverse Events
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- participants
- Interval / dispersion
- Not reported
- Time frame
- Up to Week 28 (for Part 1) and up to approximately 2.5 years (for Part 2)
What was measured
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Analysis population: All-Treated Analysis Set included all enrolled participants who received at least 1 dose of study drug.
Groups in this outcome
Part 1: Daratumumab Less Than (<) 4 mg/kg
Participants were administered with 7 full intravenous (IV) infusion of 0.005, 0.05, 0.1, 0.5, 1 and 2 milligram per kilogram body weight (mg/kg) daratumumab once weekly, along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
Part 1: Daratumumab 4 mg/kg
Participants were administered with 7 full IV infusion of 4 mg/kg daratumumab once weekly, along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
Part 1:Daratumumab 8 mg/kg
Participants were administered with 7 full IV infusion of 8 mg/kg daratumumab once weekly, along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
Part 1: Daratumumab 16 mg/kg
Participants were administered with 8 full IV infusions of 16 mg/kg daratumumab every 2 week (q2w) for 14 weeks, then every 4 weeks (q4w), along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
Part 1:Daratumumab 24 mg/kg
Participants were administered with 7 full IV infusion of 24 mg/kg daratumumab once weekly, along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
Part 2: Daratumumab 8 mg/kg
Participants were administered with 8 full IV infusions of 8 mg/kg daratumumab once weekly for 8 weeks, then every 2 weeks (q2w) for 16 weeks, then every 4 weeks (q4w) until the participant experienced disease progression or unmanageable toxicity whichever came first, along with this participants also received methylprednisolone 100 mg IV before treatment and 20-25 mg methylprednisolone orally for 2 days after all full infusions.
Part 2: Daratumumab 16 mg/kg
Participants were administered with 8 full IV infusions of 16 mg/kg daratumumab once weekly for 7 weeks, then every 2 weeks (q2w) for 14 weeks, then every 4 weeks (q4w) until the participant experienced disease progression or unmanageable toxicity whichever came first, along with this participants also received methylprednisolone 100 mg IV before treatment and 20-25 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
| Group | Source count |
|---|---|
| Part 1: Daratumumab Less Than (<) 4 mg/kg | 20 |
| Part 1: Daratumumab 4 mg/kg | 3 |
| Part 1:Daratumumab 8 mg/kg | 3 |
| Part 1: Daratumumab 16 mg/kg | 3 |
| Part 1:Daratumumab 24 mg/kg | 3 |
| Part 2: Daratumumab 8 mg/kg | 30 |
| Part 2: Daratumumab 16 mg/kg | 42 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: Daratumumab Less Than (<) 4 mg/kg | 19 | Not reported | Not reported | Not reported | Not reported |
| Part 1: Daratumumab 4 mg/kg | 3 | Not reported | Not reported | Not reported | Not reported |
| Part 1:Daratumumab 8 mg/kg | 3 | Not reported | Not reported | Not reported | Not reported |
| Part 1: Daratumumab 16 mg/kg | 3 | Not reported | Not reported | Not reported | Not reported |
| Part 1:Daratumumab 24 mg/kg | 3 | Not reported | Not reported | Not reported | Not reported |
| Part 2: Daratumumab 8 mg/kg | 30 | Not reported | Not reported | Not reported | Not reported |
| Part 2: Daratumumab 16 mg/kg | 41 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 19
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 30
- group Id
- OG006
- value
- 41
- denoms
- counts
- group Id
- OG000
- value
- 20
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 30
- group Id
- OG006
- value
- 42
- units
- Participants
- description
- An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
- groups
- description
- Participants were administered with 7 full intravenous (IV) infusion of 0.005, 0.05, 0.1, 0.5, 1 and 2 milligram per kilogram body weight (mg/kg) daratumumab once weekly, along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
- id
- OG000
- title
- Part 1: Daratumumab Less Than (<) 4 mg/kg
- description
- Participants were administered with 7 full IV infusion of 4 mg/kg daratumumab once weekly, along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
- id
- OG001
- title
- Part 1: Daratumumab 4 mg/kg
- description
- Participants were administered with 7 full IV infusion of 8 mg/kg daratumumab once weekly, along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
- id
- OG002
- title
- Part 1:Daratumumab 8 mg/kg
- description
- Participants were administered with 8 full IV infusions of 16 mg/kg daratumumab every 2 week (q2w) for 14 weeks, then every 4 weeks (q4w), along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
- id
- OG003
- title
- Part 1: Daratumumab 16 mg/kg
- description
- Participants were administered with 7 full IV infusion of 24 mg/kg daratumumab once weekly, along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
- id
- OG004
- title
- Part 1:Daratumumab 24 mg/kg
- description
- Participants were administered with 8 full IV infusions of 8 mg/kg daratumumab once weekly for 8 weeks, then every 2 weeks (q2w) for 16 weeks, then every 4 weeks (q4w) until the participant experienced disease progression or unmanageable toxicity whichever came first, along with this participants also received methylprednisolone 100 mg IV before treatment and 20-25 mg methylprednisolone orally for 2 days after all full infusions.
- id
- OG005
- title
- Part 2: Daratumumab 8 mg/kg
- description
- Participants were administered with 8 full IV infusions of 16 mg/kg daratumumab once weekly for 7 weeks, then every 2 weeks (q2w) for 14 weeks, then every 4 weeks (q4w) until the participant experienced disease progression or unmanageable toxicity whichever came first, along with this participants also received methylprednisolone 100 mg IV before treatment and 20-25 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
- id
- OG006
- title
- Part 2: Daratumumab 16 mg/kg
- param Type
- NUMBER
- population Description
- All-Treated Analysis Set included all enrolled participants who received at least 1 dose of study drug.
- reporting Status
- POSTED
- time Frame
- Up to Week 28 (for Part 1) and up to approximately 2.5 years (for Part 2)
- title
- Number of Participants With Adverse Events
- type
- PRIMARY
- unit Of Measure
- participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice