TriangleNCT02181738 · OUTCOME
Number of Participants Who Experienced at Least One Treatment Related Grade 3-5 AE in Cohort D
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 considered therapy phase to 30 days after last dose of study therapy phase (or up to first dose of combination if any when considering the monotherapy period) (an average of 8 months and a maximum of 11 months)
What was measured
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered study drug and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug.
Analysis population: All Cohort D participants treated in the monotherapy and combination therapy phases.
Groups in this outcome
Cohort D: Newly Diagnosed, Previously Untreated Advanced Stage cHL (Stage IIB, III and IV)
Four doses of nivolumab flat dose 240 mg IV were administered every 2 weeks (monotherapy phase), followed by 12 doses of the combination of AVD (adriamycin/ doxorubicin 25 mg/m2, vinblastine 6 mg/m2, dacarbazine 375 mg/m2) chemotherapy and nivolumab flat dose 240 mg IV for 6 cycles (combination phase).
| Group | Source count |
|---|---|
| Cohort D: Newly Diagnosed, Previously Untreated Advanced Stage cHL (Stage IIB, III and IV) | 51 |
Reported measurements
Monotherapy
| Group | Source count |
|---|---|
| Cohort D: Newly Diagnosed, Previously Untreated Advanced Stage cHL (Stage IIB, III and IV) | 51 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort D: Newly Diagnosed, Previously Untreated Advanced Stage cHL (Stage IIB, III and IV) | 0 | Not reported | Not reported | Not reported | Not reported |
Combination Therapy (receiving AVD or NAVD)
| Group | Source count |
|---|---|
| Cohort D: Newly Diagnosed, Previously Untreated Advanced Stage cHL (Stage IIB, III and IV) | 50 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort D: Newly Diagnosed, Previously Untreated Advanced Stage cHL (Stage IIB, III and IV) | 30 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 51
- units
- Participants
- title
- Monotherapy
- categories
- measurements
- group Id
- OG000
- value
- 30
- denoms
- counts
- group Id
- OG000
- value
- 50
- units
- Participants
- title
- Combination Therapy (receiving AVD or NAVD)
- denoms
- counts
- group Id
- OG000
- value
- 51
- units
- Participants
- description
- An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered study drug and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug.
- groups
- description
- Four doses of nivolumab flat dose 240 mg IV were administered every 2 weeks (monotherapy phase), followed by 12 doses of the combination of AVD (adriamycin/ doxorubicin 25 mg/m2, vinblastine 6 mg/m2, dacarbazine 375 mg/m2) chemotherapy and nivolumab flat dose 240 mg IV for 6 cycles (combination phase).
- id
- OG000
- title
- Cohort D: Newly Diagnosed, Previously Untreated Advanced Stage cHL (Stage IIB, III and IV)
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- All Cohort D participants treated in the monotherapy and combination therapy phases.
- reporting Status
- POSTED
- time Frame
- From first dose of the considered therapy phase to 30 days after last dose of study therapy phase (or up to first dose of combination if any when considering the monotherapy period) (an average of 8 months and a maximum of 11 months)
- title
- Number of Participants Who Experienced at Least One Treatment Related Grade 3-5 AE in Cohort D
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice