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NCT01716806 · OUTCOME

Complete Response Rate

A Study of Brentuximab Vedotin With Hodgkin Lymphoma (HL) and CD30-expressing Peripheral T-cell Lymphoma (PTCL) · Source last updated 2024-06-11

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
Percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
Up to 81 months

What was measured

Complete response rate is defined as the percentage of patients with CR

Analysis population: All subjects who received at least one dose of study drug

Groups in this outcome

Part A

Brentuximab vedotin (BV) monotherapy in adults age 60 and above with classical Hodgkin Lymphoma (cHL). BV (1.8 mg/kg) was administered as an intravenous (IV) infusion on Day 1 of each 21-day cycle.

Part B

BV in combination with dacarbazine as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Dacarbazine (375 mg/m\^2) was administered as an IV infusion on Day 1 of each 21-day cycle.

Part C

BV in combination with bendamustine as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Bendamustine (70 mg/m\^2) was administered as an IV infusion on Day 1 and Day 2 of each 21-day cycle.

Part D

BV in combination with nivolumab as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Nivolumab (3 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.

Part E

BV as frontline monotherapy in patients with cHL who were unsuitable or unfit for combination chemotherapy. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.

Part F

BV as frontline monotherapy in patients with CD30-expressing PTCL who were unsuitable or unfit for combination chemotherapy. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Part A27
Part B22
Part C20
Part D21
Part E30
Part F7

Reported measurements

Source class 1
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Part A70Not reported49.886.2Not reported
Part B64Not reported40.782.8Not reported
Part C75Not reported50.991.3Not reported
Part D67Not reported43.085.4Not reported
Part E30Not reported14.749.4Not reported
Part F43Not reported9.981.6Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        49.8
        upper Limit
        86.2
        value
        70
      2. group Id
        OG001
        lower Limit
        40.7
        upper Limit
        82.8
        value
        64
      3. group Id
        OG002
        lower Limit
        50.9
        upper Limit
        91.3
        value
        75
      4. group Id
        OG003
        lower Limit
        43.0
        upper Limit
        85.4
        value
        67
      5. group Id
        OG004
        lower Limit
        14.7
        upper Limit
        49.4
        value
        30
      6. group Id
        OG005
        lower Limit
        9.9
        upper Limit
        81.6
        value
        43
denoms
  1. counts
    1. group Id
      OG000
      value
      27
    2. group Id
      OG001
      value
      22
    3. group Id
      OG002
      value
      20
    4. group Id
      OG003
      value
      21
    5. group Id
      OG004
      value
      30
    6. group Id
      OG005
      value
      7
    units
    Participants
description
Complete response rate is defined as the percentage of patients with CR
dispersion Type
95% Confidence Interval
groups
  1. description
    Brentuximab vedotin (BV) monotherapy in adults age 60 and above with classical Hodgkin Lymphoma (cHL). BV (1.8 mg/kg) was administered as an intravenous (IV) infusion on Day 1 of each 21-day cycle.
    id
    OG000
    title
    Part A
  2. description
    BV in combination with dacarbazine as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Dacarbazine (375 mg/m\^2) was administered as an IV infusion on Day 1 of each 21-day cycle.
    id
    OG001
    title
    Part B
  3. description
    BV in combination with bendamustine as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Bendamustine (70 mg/m\^2) was administered as an IV infusion on Day 1 and Day 2 of each 21-day cycle.
    id
    OG002
    title
    Part C
  4. description
    BV in combination with nivolumab as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Nivolumab (3 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.
    id
    OG003
    title
    Part D
  5. description
    BV as frontline monotherapy in patients with cHL who were unsuitable or unfit for combination chemotherapy. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.
    id
    OG004
    title
    Part E
  6. description
    BV as frontline monotherapy in patients with CD30-expressing PTCL who were unsuitable or unfit for combination chemotherapy. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.
    id
    OG005
    title
    Part F
param Type
NUMBER
population Description
All subjects who received at least one dose of study drug
reporting Status
POSTED
time Frame
Up to 81 months
title
Complete Response Rate
type
SECONDARY
unit Of Measure
Percentage of participants

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Preserved source evidence · Not medical advice