TriangleNCT01946477 · OUTCOME
Number of Participants With Treatment Emergent Adverse Events (AEs)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- From first dose until 28 days post last dose (Up to 120 months)
What was measured
An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition occurring in a clinical investigation participant after signing of informed consent, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory test result), symptom, or disease temporally associated with the study intervention.
Analysis population: All treated participants
Groups in this outcome
Cohort A
(Pomalidomide + low dose Dexamethasone) in participants with 2 prior lines of therapy with the most recent line of therapy containing lenalidomide. The starting dose level of POM was 4 mg. The starting dose level of Dex was 40 mg/day (≤75 years old) or 20 mg/day (\> 75 years old).
Cohort B
(Pomalidomide + Daratumumab + low dose Dexamethasone) in participants with 1 or 2 prior lines of therapy with the most recent line of therapy containing lenalidomide. The starting dose level of POM was 4 mg. The starting dose level of Dex was 40 mg/day (≤75 years old) or 20 mg/day (\> 75 years old). DARA was administered intravenously (IV) at a starting dose of 16 mg/kg.
Cohort C
(Pomalidomide + Daratumumab + low dose Dexamethasone) in Japanese participants with 1 or 2 prior lines of therapy with the most recent line of therapy containing lenalidomide. The starting dose level of POM was 4 mg. The starting dose level of Dex was 40 mg/day (≤75 years old) or 20 mg/day (\> 75 years old). DARA was administered intravenously (IV) at a starting dose of 16 mg/kg.
| Group | Source count |
|---|---|
| Cohort A | 56 |
| Cohort B | 112 |
| Cohort C | 18 |
Reported measurements
TEAE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort A | 56 | Not reported | Not reported | Not reported | Not reported |
| Cohort B | 112 | Not reported | Not reported | Not reported | Not reported |
| Cohort C | 18 | Not reported | Not reported | Not reported | Not reported |
TEAE related to Pomalidomide
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort A | 40 | Not reported | Not reported | Not reported | Not reported |
| Cohort B | 105 | Not reported | Not reported | Not reported | Not reported |
| Cohort C | 17 | Not reported | Not reported | Not reported | Not reported |
TEAE related to Dexamethasone
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort A | 34 | Not reported | Not reported | Not reported | Not reported |
| Cohort B | 86 | Not reported | Not reported | Not reported | Not reported |
| Cohort C | 18 | Not reported | Not reported | Not reported | Not reported |
TEAE related to Daratumumab
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort A | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort B | 90 | Not reported | Not reported | Not reported | Not reported |
| Cohort C | 18 | Not reported | Not reported | Not reported | Not reported |
Metastatic Malignant Melanoma
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort A | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort B | 1 | Not reported | Not reported | Not reported | Not reported |
| Cohort C | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 56
- group Id
- OG001
- value
- 112
- group Id
- OG002
- value
- 18
- title
- TEAE
- categories
- measurements
- group Id
- OG000
- value
- 40
- group Id
- OG001
- value
- 105
- group Id
- OG002
- value
- 17
- title
- TEAE related to Pomalidomide
- categories
- measurements
- group Id
- OG000
- value
- 34
- group Id
- OG001
- value
- 86
- group Id
- OG002
- value
- 18
- title
- TEAE related to Dexamethasone
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 90
- group Id
- OG002
- value
- 18
- title
- TEAE related to Daratumumab
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 0
- title
- Metastatic Malignant Melanoma
- denoms
- counts
- group Id
- OG000
- value
- 56
- group Id
- OG001
- value
- 112
- group Id
- OG002
- value
- 18
- units
- Participants
- description
- An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition occurring in a clinical investigation participant after signing of informed consent, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory test result), symptom, or disease temporally associated with the study intervention.
- groups
- description
- (Pomalidomide + low dose Dexamethasone) in participants with 2 prior lines of therapy with the most recent line of therapy containing lenalidomide. The starting dose level of POM was 4 mg. The starting dose level of Dex was 40 mg/day (≤75 years old) or 20 mg/day (\> 75 years old).
- id
- OG000
- title
- Cohort A
- description
- (Pomalidomide + Daratumumab + low dose Dexamethasone) in participants with 1 or 2 prior lines of therapy with the most recent line of therapy containing lenalidomide. The starting dose level of POM was 4 mg. The starting dose level of Dex was 40 mg/day (≤75 years old) or 20 mg/day (\> 75 years old). DARA was administered intravenously (IV) at a starting dose of 16 mg/kg.
- id
- OG001
- title
- Cohort B
- description
- (Pomalidomide + Daratumumab + low dose Dexamethasone) in Japanese participants with 1 or 2 prior lines of therapy with the most recent line of therapy containing lenalidomide. The starting dose level of POM was 4 mg. The starting dose level of Dex was 40 mg/day (≤75 years old) or 20 mg/day (\> 75 years old). DARA was administered intravenously (IV) at a starting dose of 16 mg/kg.
- id
- OG002
- title
- Cohort C
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- All treated participants
- reporting Status
- POSTED
- time Frame
- From first dose until 28 days post last dose (Up to 120 months)
- title
- Number of Participants With Treatment Emergent Adverse Events (AEs)
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice