NCT02181738 · OUTCOME

Number of Participants Who Died 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 of the considered therapy phase to 100 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 10 months up to a maximum of 13 months)

What was measured

Number of participants who died in Cohort D within 100 days after last dose of study therapy.

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)	0	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)	1	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
1
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

Number of participants who died in Cohort D within 100 days after last dose of study therapy.

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 100 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 10 months up to a maximum of 13 months)

title

Number of Participants Who Died in Cohort D

type

SECONDARY

unit Of Measure

Participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice