TriangleNCT03567616 · 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
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- From first dose of study drug until 30 days following last dose of study drug (up to 70 weeks)
What was measured
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either reasonable possibility or no reasonable possibility. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug. For more details on adverse events please see the Adverse Event section.
Analysis population: Safety Analysis Set: participants who received at least 1 dose of study drug (venetoclax 400 mg, pomalidomide 4 mg, and dexamethasone 40 mg)
Groups in this outcome
Participants Positive for t(11;14) Translocation
Participants positive for t(11;14) translocation who received at least 1 dose of study drug (venetoclax 400 mg, pomalidomide 4 mg, and dexamethasone 40 mg)
Participants Negative for t(11;14) Translocation
Participants negative for t(11;14) translocation who received at least 1 dose of study drug (venetoclax 400 mg, pomalidomide 4 mg, and dexamethasone 40 mg)
| Group | Source count |
|---|---|
| Participants Positive for t(11;14) Translocation | 3 |
| Participants Negative for t(11;14) Translocation | 5 |
Reported measurements
Any TEAE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Participants Positive for t(11;14) Translocation | 3 | Not reported | Not reported | Not reported | Not reported |
| Participants Negative for t(11;14) Translocation | 5 | Not reported | Not reported | Not reported | Not reported |
TESAE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Participants Positive for t(11;14) Translocation | 3 | Not reported | Not reported | Not reported | Not reported |
| Participants Negative for t(11;14) Translocation | 2 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- calculate Pct
- false
- classes
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 5
- title
- Any TEAE
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 2
- title
- TESAE
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 5
- units
- Participants
- description
- An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either reasonable possibility or no reasonable possibility. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug. For more details on adverse events please see the Adverse Event section.
- groups
- description
- Participants positive for t(11;14) translocation who received at least 1 dose of study drug (venetoclax 400 mg, pomalidomide 4 mg, and dexamethasone 40 mg)
- id
- OG000
- title
- Participants Positive for t(11;14) Translocation
- description
- Participants negative for t(11;14) translocation who received at least 1 dose of study drug (venetoclax 400 mg, pomalidomide 4 mg, and dexamethasone 40 mg)
- id
- OG001
- title
- Participants Negative for t(11;14) Translocation
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Safety Analysis Set: participants who received at least 1 dose of study drug (venetoclax 400 mg, pomalidomide 4 mg, and dexamethasone 40 mg)
- reporting Status
- POSTED
- time Frame
- From first dose of study drug until 30 days following last dose of study drug (up to 70 weeks)
- title
- Number of Participants With Adverse Events
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice