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NCT01805037 · OUTCOME

Number of Participants With Adverse Events Possibly Related to Study Drug Graded 3, 4, and 5

Brentuximab Vedotin + Rituximab as Frontline Therapy for Pts w/ CD30+ and/or EBV+ Lymphomas · Source last updated 2021-09-01

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 time of treatment to 30 days post discontinuation (range of cycles attempted from induction +/- consolidation, & maintenance = 1-17 cycles) About 1 year Induction = 4 weeks, consolidation = 4 weeks, 1 maintenance cycle = 3 weeks

What was measured

Toxicity, both frequency and severity, will continue to be measured by monitoring the occurrence of adverse events. Adverse events will be defined as those included in CTCAE v 4.03. AEs that were determined to be at least possibly related to study drug and graded 3, 4, 5 are included here. Grade 1 (mild): the event causes discomfort without disruption of normal daily activities. Grade 2 (moderate): the event causes discomfort that affects normal daily activities. Grade 3 (severe): the event makes the patient unable to perform normal daily activities or significantly affects his/her clinical status. Grade 4 (Life-threatening): the patient was at risk of death at the time of the event. Grade 5 (fatal): the event caused death.

Groups in this outcome

Brentuximb Vedotin Dose Level 1 (1.2 mg/kg)

Induction: * Brentuximab vedotin 1.2 mg/kg IV infusion over 30 minutes, weekly x 3 (1 cycle = 4 weeks * Rituximab 375 mg/m2 IV infusion per standard protocol, once weekly for 4 weeks (1 cycle = 4 weeks) Consolidation (optional): Identical to Induction. Maintenance: * Brentuximab vedotin 1.8 mg/kg IV infusion over 30 minutes once every 3 weeks (1 cycle = 3 weeks), for a total of one year from the first induction dose or until progression of disease. * Rituximab 375 mg/m2 IV infusion per standard protocol, once every 6 weeks for a total of one year from the first induction dose or until progression of disease.

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

Analysis denominator · Participants

GroupSource count
Brentuximb Vedotin Dose Level 1 (1.2 mg/kg)20

Reported measurements

Grade 3 Diarrhea
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Brentuximb Vedotin Dose Level 1 (1.2 mg/kg)1Not reportedNot reportedNot reportedNot reported
Grade 4 Hyperbilirubinemia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Brentuximb Vedotin Dose Level 1 (1.2 mg/kg)1Not reportedNot reportedNot reportedNot reported
Grade 3 AST elevation
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Brentuximb Vedotin Dose Level 1 (1.2 mg/kg)2Not reportedNot reportedNot reportedNot reported
Grade 4 Lipase elevation
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Brentuximb Vedotin Dose Level 1 (1.2 mg/kg)2Not reportedNot reportedNot reportedNot reported
Grade 3 Amylase elevation
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Brentuximb Vedotin Dose Level 1 (1.2 mg/kg)1Not reportedNot reportedNot reportedNot reported
Grade 4 Amylase elevation
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Brentuximb Vedotin Dose Level 1 (1.2 mg/kg)1Not reportedNot reportedNot reportedNot reported
Grade 4 Typhlitis
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Brentuximb Vedotin Dose Level 1 (1.2 mg/kg)1Not reportedNot reportedNot reportedNot reported
Grade 3 Anemia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Brentuximb Vedotin Dose Level 1 (1.2 mg/kg)2Not reportedNot reportedNot reportedNot reported
Grade 3 Febrile Neutropenia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Brentuximb Vedotin Dose Level 1 (1.2 mg/kg)1Not reportedNot reportedNot reportedNot reported
Grade 3 Lymphopenia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Brentuximb Vedotin Dose Level 1 (1.2 mg/kg)7Not reportedNot reportedNot reportedNot reported
Grade 4 Lymphopenia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Brentuximb Vedotin Dose Level 1 (1.2 mg/kg)2Not reportedNot reportedNot reportedNot reported
Grade 4 Neutropenia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Brentuximb Vedotin Dose Level 1 (1.2 mg/kg)1Not reportedNot reportedNot reportedNot reported
Grade 3 Neutropenia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Brentuximb Vedotin Dose Level 1 (1.2 mg/kg)7Not reportedNot reportedNot reportedNot reported
Grade 3 Elevated creatinine
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Brentuximb Vedotin Dose Level 1 (1.2 mg/kg)1Not reportedNot reportedNot reportedNot reported
Grade 3 Acute kidney injury
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Brentuximb Vedotin Dose Level 1 (1.2 mg/kg)2Not reportedNot reportedNot reportedNot reported
Grade 3 Hypophosphatemia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Brentuximb Vedotin Dose Level 1 (1.2 mg/kg)1Not reportedNot reportedNot reportedNot reported
Grade 3 Peripheral neuropathy
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Brentuximb Vedotin Dose Level 1 (1.2 mg/kg)2Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Grade 3 Diarrhea
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Grade 4 Hyperbilirubinemia
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Grade 3 AST elevation
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Grade 4 Lipase elevation
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Grade 3 Amylase elevation
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Grade 4 Amylase elevation
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Grade 4 Typhlitis
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Grade 3 Anemia
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Grade 3 Febrile Neutropenia
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        7
    title
    Grade 3 Lymphopenia
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Grade 4 Lymphopenia
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Grade 4 Neutropenia
denoms
  1. counts
    1. group Id
      OG000
      value
      20
    units
    Participants
description
Toxicity, both frequency and severity, will continue to be measured by monitoring the occurrence of adverse events. Adverse events will be defined as those included in CTCAE v 4.03. AEs that were determined to be at least possibly related to study drug and graded 3, 4, 5 are included here. Grade 1 (mild): the event causes discomfort without disruption of normal daily activities. Grade 2 (moderate): the event causes discomfort that affects normal daily activities. Grade 3 (severe): the event makes the patient unable to perform normal daily activities or significantly affects his/her clinical status. Grade 4 (Life-threatening): the patient was at risk of death at the time of the event. Grade 5 (fatal): the event caused death.
groups
  1. description
    Induction: * Brentuximab vedotin 1.2 mg/kg IV infusion over 30 minutes, weekly x 3 (1 cycle = 4 weeks * Rituximab 375 mg/m2 IV infusion per standard protocol, once weekly for 4 weeks (1 cycle = 4 weeks) Consolidation (optional): Identical to Induction. Maintenance: * Brentuximab vedotin 1.8 mg/kg IV infusion over 30 minutes once every 3 weeks (1 cycle = 3 weeks), for a total of one year from the first induction dose or until progression of disease. * Rituximab 375 mg/m2 IV infusion per standard protocol, once every 6 weeks for a total of one year from the first induction dose or until progression of disease.
    id
    OG000
    title
    Brentuximb Vedotin Dose Level 1 (1.2 mg/kg)
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
From time of treatment to 30 days post discontinuation (range of cycles attempted from induction +/- consolidation, & maintenance = 1-17 cycles) About 1 year Induction = 4 weeks, consolidation = 4 weeks, 1 maintenance cycle = 3 weeks
title
Number of Participants With Adverse Events Possibly Related to Study Drug Graded 3, 4, and 5
type
SECONDARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice