TriangleNCT01578499 · OUTCOME
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
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
- First dose of study drug through 30 days after last dose of study drug (Up to 450 days)
What was measured
AEs and SAEs were assessed according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A SAE is any AE that results in death, is life-threatening, requires inpatient hospitalization or prolongation of an existing hospitalization, results in significant disability or incapacity, is a congenital anomaly/birth defect or is a medically important event.
Analysis population: The Safety population included participants who received at least one dose of study drug.
Groups in this outcome
Brentuximab Vedotin
Brentuximab vedotin 1.8 mg/kg, intravenous over approximately 30 minutes, once on Day 1 of each 21-day cycle and may continue as monotherapy for up to a total of 16 cycles (48 weeks).
Methotrexate or Bexarotene
Methotrexate 5 to 50 mg, tablets, orally, once weekly (dose adjustment is guided by patient response and toxicity) or Bexarotene 300 mg/m\^2, tablets, orally, once daily with meals for up to 48 weeks.
| Group | Source count |
|---|---|
| Brentuximab Vedotin | 66 |
| Methotrexate or Bexarotene | 62 |
Reported measurements
AEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Brentuximab Vedotin | 63 | Not reported | Not reported | Not reported | Not reported |
| Methotrexate or Bexarotene | 56 | Not reported | Not reported | Not reported | Not reported |
SAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Brentuximab Vedotin | 18 | Not reported | Not reported | Not reported | Not reported |
| Methotrexate or Bexarotene | 18 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 63
- group Id
- OG001
- value
- 56
- title
- AEs
- categories
- measurements
- group Id
- OG000
- value
- 18
- group Id
- OG001
- value
- 18
- title
- SAEs
- denoms
- counts
- group Id
- OG000
- value
- 66
- group Id
- OG001
- value
- 62
- units
- Participants
- description
- AEs and SAEs were assessed according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A SAE is any AE that results in death, is life-threatening, requires inpatient hospitalization or prolongation of an existing hospitalization, results in significant disability or incapacity, is a congenital anomaly/birth defect or is a medically important event.
- groups
- description
- Brentuximab vedotin 1.8 mg/kg, intravenous over approximately 30 minutes, once on Day 1 of each 21-day cycle and may continue as monotherapy for up to a total of 16 cycles (48 weeks).
- id
- OG000
- title
- Brentuximab Vedotin
- description
- Methotrexate 5 to 50 mg, tablets, orally, once weekly (dose adjustment is guided by patient response and toxicity) or Bexarotene 300 mg/m\^2, tablets, orally, once daily with meals for up to 48 weeks.
- id
- OG001
- title
- Methotrexate or Bexarotene
- param Type
- NUMBER
- population Description
- The Safety population included participants who received at least one dose of study drug.
- reporting Status
- POSTED
- time Frame
- First dose of study drug through 30 days after last dose of study drug (Up to 450 days)
- title
- Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
- type
- SECONDARY
- unit Of Measure
- participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice