TriangleNCT04569032 · OUTCOME
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs) and Treatment Related Adverse Events by Local CD30 Assessment
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 the study treatment (Day 1) up to 30-37 days after the last dose of study treatment (approximately up to 6.6 months)
What was measured
An adverse event was any untoward medical occurrence in a participant or clinical investigational participant administered a medicinal product and which did not necessarily have a causal relationship with this treatment. An adverse event was classified as a serious adverse event (SAE) if it met one of the following criteria: fatal, life threatening, hospitalization, disabling/incapacitating, congenital anomaly or birth defect or any medically significant event. TEAEs were events if they were newly occurring or worsen following study treatment. TESAE is any SAE that met treatment emergent definition. Treatment related AEs were which had evidence to suggest a causal relationship between the drugs and the adverse event, such as: an event that was uncommon and known to be strongly associated with drug exposure, an event that was not commonly associated with drug exposure but was otherwise uncommon in the population exposed to the drug. AEs included both SAEs and all non-SAEs.
Analysis population: FAS included all participants who received any amount of brentuximab vedotin or any component of CHP.
Groups in this outcome
CD30 <1% [Local Laboratory Assessment]
Participants with \<1% CD30 expression (per local laboratory assessment) received A+CHP treatment in 21-day cycle. Brentuximab vedotin as 1.8 milligrams per kilogram (mg/kg) intravenously (IV) on Day 1 of each 21-day cycle, Cyclophosphamide 750 milligram per square meter (mg/m\^2) IV on Day 1 of each 21-day cycle, Doxorubicin 50 mg/m\^2 IV on Day 1 of each 21-day cycle, Prednisone 100 mg orally on Days 1-5 of each 21-day cycle.
CD30 1% to <10% [Local Laboratory Assessment]
Participants with 1% to \<10% CD30 expression (per local laboratory assessment) received A+CHP treatment in 21-day cycle. Brentuximab vedotin as 1.8 mg/kg IV on Day 1 of each 21-day cycle, Cyclophosphamide 750 mg/m\^2 IV on Day 1 of each 21-day cycle, Doxorubicin 50 mg/m\^2 IV on Day 1 of each 21-day cycle, Prednisone 100 mg orally on Days 1-5 of each 21-day cycle.
| Group | Source count |
|---|---|
| CD30 <1% [Local Laboratory Assessment] | 34 |
| CD30 1% to <10% [Local Laboratory Assessment] | 48 |
Reported measurements
TEAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| CD30 <1% [Local Laboratory Assessment] | 32 | Not reported | Not reported | Not reported | Not reported |
| CD30 1% to <10% [Local Laboratory Assessment] | 46 | Not reported | Not reported | Not reported | Not reported |
TESAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| CD30 <1% [Local Laboratory Assessment] | 15 | Not reported | Not reported | Not reported | Not reported |
| CD30 1% to <10% [Local Laboratory Assessment] | 16 | Not reported | Not reported | Not reported | Not reported |
Treatment related TEAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| CD30 <1% [Local Laboratory Assessment] | 25 | Not reported | Not reported | Not reported | Not reported |
| CD30 1% to <10% [Local Laboratory Assessment] | 40 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 32
- group Id
- OG001
- value
- 46
- title
- TEAEs
- categories
- measurements
- group Id
- OG000
- value
- 15
- group Id
- OG001
- value
- 16
- title
- TESAEs
- categories
- measurements
- group Id
- OG000
- value
- 25
- group Id
- OG001
- value
- 40
- title
- Treatment related TEAEs
- denoms
- counts
- group Id
- OG000
- value
- 34
- group Id
- OG001
- value
- 48
- units
- Participants
- description
- An adverse event was any untoward medical occurrence in a participant or clinical investigational participant administered a medicinal product and which did not necessarily have a causal relationship with this treatment. An adverse event was classified as a serious adverse event (SAE) if it met one of the following criteria: fatal, life threatening, hospitalization, disabling/incapacitating, congenital anomaly or birth defect or any medically significant event. TEAEs were events if they were newly occurring or worsen following study treatment. TESAE is any SAE that met treatment emergent definition. Treatment related AEs were which had evidence to suggest a causal relationship between the drugs and the adverse event, such as: an event that was uncommon and known to be strongly associated with drug exposure, an event that was not commonly associated with drug exposure but was otherwise uncommon in the population exposed to the drug. AEs included both SAEs and all non-SAEs.
- groups
- description
- Participants with \<1% CD30 expression (per local laboratory assessment) received A+CHP treatment in 21-day cycle. Brentuximab vedotin as 1.8 milligrams per kilogram (mg/kg) intravenously (IV) on Day 1 of each 21-day cycle, Cyclophosphamide 750 milligram per square meter (mg/m\^2) IV on Day 1 of each 21-day cycle, Doxorubicin 50 mg/m\^2 IV on Day 1 of each 21-day cycle, Prednisone 100 mg orally on Days 1-5 of each 21-day cycle.
- id
- OG000
- title
- CD30 <1% [Local Laboratory Assessment]
- description
- Participants with 1% to \<10% CD30 expression (per local laboratory assessment) received A+CHP treatment in 21-day cycle. Brentuximab vedotin as 1.8 mg/kg IV on Day 1 of each 21-day cycle, Cyclophosphamide 750 mg/m\^2 IV on Day 1 of each 21-day cycle, Doxorubicin 50 mg/m\^2 IV on Day 1 of each 21-day cycle, Prednisone 100 mg orally on Days 1-5 of each 21-day cycle.
- id
- OG001
- title
- CD30 1% to <10% [Local Laboratory Assessment]
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- FAS included all participants who received any amount of brentuximab vedotin or any component of CHP.
- reporting Status
- POSTED
- time Frame
- From first dose of the study treatment (Day 1) up to 30-37 days after the last dose of study treatment (approximately up to 6.6 months)
- title
- Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs) and Treatment Related Adverse Events by Local CD30 Assessment
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice