TriangleNCT04213209 · OUTCOME
Percentage of Participants Who Had One or More Serious or Non-serious Adverse Drug Reaction Classified as Myelosuppression
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
- Up to 12 Months
What was measured
An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Adverse drug reaction refers to AE related to administered drug. Percentage of participants who had one or more serious or non-serious adverse drug reaction of febrile neutropenia, neutropenia, or neutrophil count decreased which were classified as myelosuppression was reported.
Analysis population: Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.
Groups in this outcome
Adult Participants With PTCL-NOS
Adult participants with peripheral T-cell lymphoma not otherwise specified (PTCL-NOS) were received brentuximab vedotin (genetic recombination) 1.8 milligrams per kilograms (mg/kg) (body weight), intravenous infusion, once every three weeks (up to 12 months). The dose should be reduced appropriately depend on the participant's condition. Participants received interventions as part of routine medical care.
Adult Participants With AITL
Adult participants with angioimmunoblastic T-cell lymphoma (AITL) were received brentuximab vedotin (genetic recombination) 1.8 milligrams per kilograms (mg/kg) (body weight), intravenous infusion, once every three weeks (up to 12 months). The dose should be reduced appropriately depend on the participant's condition. Participants received interventions as part of routine medical care.
Adult Participants With ATLL
Adult participants with adult T-cell leukemia/lymphoma (ATLL) were received brentuximab vedotin (genetic recombination) 1.8 milligrams per kilograms (mg/kg) (body weight), intravenous infusion, once every three weeks (up to 12 months). The dose should be reduced appropriately depend on the participant's condition. Participants received interventions as part of routine medical care.
Adult Participants With Other PTCL
Adult participants with the other PTCL (peripheral T-cell lymphoma \[PTCL\] subtypes other than anaplastic large-cell lymphoma \[ALCL\] \[not surveyed\], PTCL-NOS, AITL, and ATLL) were received brentuximab vedotin (genetic recombination) 1.8 milligrams per kilograms (mg/kg) (body weight), intravenous infusion, once every three weeks (up to 12 months). The dose should be reduced appropriately depend on the participant's condition. Participants received interventions as part of routine medical care.
Pediatric Participants With PTCL
Pediatric participants with peripheral T-cell lymphoma (PTCL) were received brentuximab vedotin (genetic recombination) 1.8 milligrams per kilograms (mg/kg) (body weight), intravenous infusion, once every three weeks (up to 12 months). The dose should be reduced appropriately depend on the participant's condition. Participants received interventions as part of routine medical care.
Pediatric Participants With HL
Pediatric participants with Hodgkin lymphoma (HL) were received brentuximab vedotin (genetic recombination) 1.8 milligrams per kilograms (mg/kg) (body weight), intravenous infusion, once every three weeks (up to 12 months). The dose should be reduced appropriately depend on the participant's condition. Participants received interventions as part of routine medical care.
| Group | Source count |
|---|---|
| Adult Participants With PTCL-NOS | 31 |
| Adult Participants With AITL | 35 |
| Adult Participants With ATLL | 14 |
| Adult Participants With Other PTCL | 6 |
| Pediatric Participants With PTCL | 4 |
| Pediatric Participants With HL | 4 |
Reported measurements
Serious: Febrile Neutropenia
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Adult Participants With PTCL-NOS | 1 | Not reported | Not reported | Not reported | Not reported |
| Adult Participants With AITL | 0 | Not reported | Not reported | Not reported | Not reported |
| Adult Participants With ATLL | 0 | Not reported | Not reported | Not reported | Not reported |
| Adult Participants With Other PTCL | 0 | Not reported | Not reported | Not reported | Not reported |
| Pediatric Participants With PTCL | 0 | Not reported | Not reported | Not reported | Not reported |
| Pediatric Participants With HL | 0 | Not reported | Not reported | Not reported | Not reported |
Non-Serious: Febrile Neutropenia
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Adult Participants With PTCL-NOS | 0 | Not reported | Not reported | Not reported | Not reported |
| Adult Participants With AITL | 0 | Not reported | Not reported | Not reported | Not reported |
| Adult Participants With ATLL | 0 | Not reported | Not reported | Not reported | Not reported |
| Adult Participants With Other PTCL | 0 | Not reported | Not reported | Not reported | Not reported |
| Pediatric Participants With PTCL | 0 | Not reported | Not reported | Not reported | Not reported |
| Pediatric Participants With HL | 0 | Not reported | Not reported | Not reported | Not reported |
Serious: Neutropenia
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Adult Participants With PTCL-NOS | 1 | Not reported | Not reported | Not reported | Not reported |
| Adult Participants With AITL | 0 | Not reported | Not reported | Not reported | Not reported |
| Adult Participants With ATLL | 0 | Not reported | Not reported | Not reported | Not reported |
| Adult Participants With Other PTCL | 0 | Not reported | Not reported | Not reported | Not reported |
| Pediatric Participants With PTCL | 0 | Not reported | Not reported | Not reported | Not reported |
| Pediatric Participants With HL | 0 | Not reported | Not reported | Not reported | Not reported |
Non-Serious: Neutropenia
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Adult Participants With PTCL-NOS | 0 | Not reported | Not reported | Not reported | Not reported |
| Adult Participants With AITL | 0 | Not reported | Not reported | Not reported | Not reported |
| Adult Participants With ATLL | 0 | Not reported | Not reported | Not reported | Not reported |
| Adult Participants With Other PTCL | 0 | Not reported | Not reported | Not reported | Not reported |
| Pediatric Participants With PTCL | 0 | Not reported | Not reported | Not reported | Not reported |
| Pediatric Participants With HL | 0 | Not reported | Not reported | Not reported | Not reported |
Serious: Neutrophil Count Decreased
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Adult Participants With PTCL-NOS | 3 | Not reported | Not reported | Not reported | Not reported |
| Adult Participants With AITL | 0 | Not reported | Not reported | Not reported | Not reported |
| Adult Participants With ATLL | 0 | Not reported | Not reported | Not reported | Not reported |
| Adult Participants With Other PTCL | 0 | Not reported | Not reported | Not reported | Not reported |
| Pediatric Participants With PTCL | 0 | Not reported | Not reported | Not reported | Not reported |
| Pediatric Participants With HL | 0 | Not reported | Not reported | Not reported | Not reported |
Non-Serious: Neutrophil Count Decreased
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Adult Participants With PTCL-NOS | 9 | Not reported | Not reported | Not reported | Not reported |
| Adult Participants With AITL | 3 | Not reported | Not reported | Not reported | Not reported |
| Adult Participants With ATLL | 2 | Not reported | Not reported | Not reported | Not reported |
| Adult Participants With Other PTCL | 0 | Not reported | Not reported | Not reported | Not reported |
| Pediatric Participants With PTCL | 0 | Not reported | Not reported | Not reported | Not reported |
| Pediatric Participants With HL | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- title
- Serious: Febrile Neutropenia
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- title
- Non-Serious: Febrile Neutropenia
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- title
- Serious: Neutropenia
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- title
- Non-Serious: Neutropenia
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- title
- Serious: Neutrophil Count Decreased
- categories
- measurements
- group Id
- OG000
- value
- 9
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- title
- Non-Serious: Neutrophil Count Decreased
- denoms
- counts
- group Id
- OG000
- value
- 31
- group Id
- OG001
- value
- 35
- group Id
- OG002
- value
- 14
- group Id
- OG003
- value
- 6
- group Id
- OG004
- value
- 4
- group Id
- OG005
- value
- 4
- units
- Participants
- description
- An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Adverse drug reaction refers to AE related to administered drug. Percentage of participants who had one or more serious or non-serious adverse drug reaction of febrile neutropenia, neutropenia, or neutrophil count decreased which were classified as myelosuppression was reported.
- groups
- description
- Adult participants with peripheral T-cell lymphoma not otherwise specified (PTCL-NOS) were received brentuximab vedotin (genetic recombination) 1.8 milligrams per kilograms (mg/kg) (body weight), intravenous infusion, once every three weeks (up to 12 months). The dose should be reduced appropriately depend on the participant's condition. Participants received interventions as part of routine medical care.
- id
- OG000
- title
- Adult Participants With PTCL-NOS
- description
- Adult participants with angioimmunoblastic T-cell lymphoma (AITL) were received brentuximab vedotin (genetic recombination) 1.8 milligrams per kilograms (mg/kg) (body weight), intravenous infusion, once every three weeks (up to 12 months). The dose should be reduced appropriately depend on the participant's condition. Participants received interventions as part of routine medical care.
- id
- OG001
- title
- Adult Participants With AITL
- description
- Adult participants with adult T-cell leukemia/lymphoma (ATLL) were received brentuximab vedotin (genetic recombination) 1.8 milligrams per kilograms (mg/kg) (body weight), intravenous infusion, once every three weeks (up to 12 months). The dose should be reduced appropriately depend on the participant's condition. Participants received interventions as part of routine medical care.
- id
- OG002
- title
- Adult Participants With ATLL
- description
- Adult participants with the other PTCL (peripheral T-cell lymphoma \[PTCL\] subtypes other than anaplastic large-cell lymphoma \[ALCL\] \[not surveyed\], PTCL-NOS, AITL, and ATLL) were received brentuximab vedotin (genetic recombination) 1.8 milligrams per kilograms (mg/kg) (body weight), intravenous infusion, once every three weeks (up to 12 months). The dose should be reduced appropriately depend on the participant's condition. Participants received interventions as part of routine medical care.
- id
- OG003
- title
- Adult Participants With Other PTCL
- description
- Pediatric participants with peripheral T-cell lymphoma (PTCL) were received brentuximab vedotin (genetic recombination) 1.8 milligrams per kilograms (mg/kg) (body weight), intravenous infusion, once every three weeks (up to 12 months). The dose should be reduced appropriately depend on the participant's condition. Participants received interventions as part of routine medical care.
- id
- OG004
- title
- Pediatric Participants With PTCL
- description
- Pediatric participants with Hodgkin lymphoma (HL) were received brentuximab vedotin (genetic recombination) 1.8 milligrams per kilograms (mg/kg) (body weight), intravenous infusion, once every three weeks (up to 12 months). The dose should be reduced appropriately depend on the participant's condition. Participants received interventions as part of routine medical care.
- id
- OG005
- title
- Pediatric Participants With HL
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.
- reporting Status
- POSTED
- time Frame
- Up to 12 Months
- title
- Percentage of Participants Who Had One or More Serious or Non-serious Adverse Drug Reaction Classified as Myelosuppression
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice