NCT02181738 · OUTCOME
Treatment Discontinuation Rate in Cohort D
Study of Nivolumab in Patients With Classical Hodgkin's Lymphoma (Registrational) · Source last updated 2023-11-28
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 up until the date of treatment discontinuation (up to approximately 100 months).
What was measured
Treatment discontinuation rate (TDR) is the number of treated participants who received \<4 doses of monotherapy or \<12 doses of their assigned combination regimen. A participant is considered as having received an AVD/NAVD dose as soon as they received at least one drug of AVD/NAVD for the considered dose. Participants must have received at least one dose of Nivolumab during the combination therapy phase to be included in participants treated with NAVD. If a participant subsequently met Criteria to Resume Nivolumab Dosing, the combination of nivolumab and AVD could be used. Participants who underwent treatment beyond progression during the Monotherapy phase could use the combination of nivolumab and AVD if all 4 doses of nivolumab monotherapy are completed.
Discontinuation can be due to any reason including, but not limited to, drug-related toxicity, diseases progression, or death.
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 identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Cohort D: Newly Diagnosed, Previously Untreated Advanced Stage cHL (Stage IIB, III and IV) | 51 |
|---|
Reported measurements
Monotherapy
Analysis denominator · Participants
| Group | Source count |
|---|
| Cohort D: Newly Diagnosed, Previously Untreated Advanced Stage cHL (Stage IIB, III and IV) | 51 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort D: Newly Diagnosed, Previously Untreated Advanced Stage cHL (Stage IIB, III and IV) | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
Combination Therapy (receiving AVD or NAVD)
Analysis denominator · Participants
| Group | Source count |
|---|
| Cohort D: Newly Diagnosed, Previously Untreated Advanced Stage cHL (Stage IIB, III and IV) | 50 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort D: Newly Diagnosed, Previously Untreated Advanced Stage cHL (Stage IIB, III and IV) | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
Combination Therapy (NAVD receivers only)
Analysis denominator · Participants
| Group | Source count |
|---|
| Cohort D: Newly Diagnosed, Previously Untreated Advanced Stage cHL (Stage IIB, III and IV) | 49 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort D: Newly Diagnosed, Previously Untreated Advanced Stage cHL (Stage IIB, III and IV) | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
Overall Therapy
Analysis denominator · Participants
| Group | Source count |
|---|
| Cohort D: Newly Diagnosed, Previously Untreated Advanced Stage cHL (Stage IIB, III and IV) | 51 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort D: Newly Diagnosed, Previously Untreated Advanced Stage cHL (Stage IIB, III and IV) | 6 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- title
- Monotherapy
- title
- Combination Therapy (receiving AVD or NAVD)
- title
- Combination Therapy (NAVD receivers only)
- title
- Overall Therapy
- description
- Treatment discontinuation rate (TDR) is the number of treated participants who received \<4 doses of monotherapy or \<12 doses of their assigned combination regimen. A participant is considered as having received an AVD/NAVD dose as soon as they received at least one drug of AVD/NAVD for the considered dose. Participants must have received at least one dose of Nivolumab during the combination therapy phase to be included in participants treated with NAVD. If a participant subsequently met Criteria to Resume Nivolumab Dosing, the combination of nivolumab and AVD could be used. Participants who underwent treatment beyond progression during the Monotherapy phase could use the combination of nivolumab and AVD if all 4 doses of nivolumab monotherapy are completed.
Discontinuation can be due to any reason including, but not limited to, drug-related toxicity, diseases progression, or death.
- 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 up until the date of treatment discontinuation (up to approximately 100 months).
- title
- Treatment Discontinuation Rate in Cohort D
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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