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NCT01920932 · OUTCOME

Descriptive of Infectious Adverse Events

Adcetris (Brentuximab Vedotin), Combination Chemotherapy, and Radiation Therapy in Treating Younger Patients With Stage IIB, IIIB and IV Hodgkin Lymphoma · Source last updated 2026-05-06

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 enrollment to end of therapy (approximately 8 months)

What was measured

To describe acute hematologic, neuropathic, and infectious toxicities as they relate to transfusion requirements, growth factor support, episodes of febrile neutropenia and hospitalizations, according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 4.0.

Analysis population: Toxicities reported below for the current study (HLHR13) include all reported infectious toxicities from a participant's on-study date through end of therapy.

Groups in this outcome

Cycle 1 - Grade 2

Participants receive AEPA regimen for 2 cycles (cycle length 28 days) (A) Brentuximab vedotin 1.2 mg/kg IV (E) Etoposide 125 mg/m\^2 IV (P) Prednisone 60 mg/m\^2/day PO (orally) (A) Doxorubicin 40 mg/m\^2 IV For those with lymph nodes that do not go into remission after 2 courses of AEPA chemotherapy, radiation therapy will be given.

Cycle 1 - Grade 3-4

Participants receive AEPA regimen for 2 cycles (cycle length 28 days) (A) Brentuximab vedotin 1.2 mg/kg IV (E) Etoposide 125 mg/m\^2 IV (P) Prednisone 60 mg/m\^2/day PO (orally) (A) Doxorubicin 40 mg/m\^2 IV For those with lymph nodes that do not go into remission after 2 courses of AEPA chemotherapy, radiation therapy will be given.

Cycle 2 - Grade 2

Participants receive AEPA regimen for 2 cycles (cycle length 28 days) (A) Brentuximab vedotin 1.2 mg/kg IV (E) Etoposide 125 mg/m\^2 IV (P) Prednisone 60 mg/m\^2/day PO (orally) (A) Doxorubicin 40 mg/m\^2 IV For those with lymph nodes that do not go into remission after 2 courses of AEPA chemotherapy, radiation therapy will be given.

Cycle 2 - Grade 3-4

Participants receive AEPA regimen for 2 cycles (cycle length 28 days) (A) Brentuximab vedotin 1.2 mg/kg IV (E) Etoposide 125 mg/m\^2 IV (P) Prednisone 60 mg/m\^2/day PO (orally) (A) Doxorubicin 40 mg/m\^2 IV For those with lymph nodes that do not go into remission after 2 courses of AEPA chemotherapy, radiation therapy will be given.

Cycle 3 - Grade 2

Participants receive CAPDac regimen for 4 cycles (cycle length 21 days): (C) Cyclophosphamide IV 500 mg/m\^2 (A) Brentuximab vedotin 1.2 mg/kg IV (P) Prednisone 40 mg/40 mg/m\^2/day PO (Dac) Dacarbazine 250 mg/m\^2 IV

Cycle 3 - Grade 3-4

Participants receive CAPDac regimen for 4 cycles (cycle length 21 days): (C) Cyclophosphamide IV 500 mg/m\^2 (A) Brentuximab vedotin 1.2 mg/kg IV (P) Prednisone 40 mg/40 mg/m\^2/day PO (Dac) Dacarbazine 250 mg/m\^2 IV

Cycle 4 - Grade 2

Participants receive CAPDac regimen for 4 cycles (cycle length 21 days): (C) Cyclophosphamide IV 500 mg/m\^2 (A) Brentuximab vedotin 1.2 mg/kg IV (P) Prednisone 40 mg/40 mg/m\^2/day PO (Dac) Dacarbazine 250 mg/m\^2 IV

Cycle 4 - Grade 3-4

Participants receive CAPDac regimen for 4 cycles (cycle length 21 days): (C) Cyclophosphamide IV 500 mg/m\^2 (A) Brentuximab vedotin 1.2 mg/kg IV (P) Prednisone 40 mg/40 mg/m\^2/day PO (Dac) Dacarbazine 250 mg/m\^2 IV

Cycle 5 - Grade 2

Participants receive CAPDac regimen for 4 cycles (cycle length 21 days): (C) Cyclophosphamide IV 500 mg/m\^2 (A) Brentuximab vedotin 1.2 mg/kg IV (P) Prednisone 40 mg/40 mg/m\^2/day PO (Dac) Dacarbazine 250 mg/m\^2 IV

Cycle 5 - Grade 3-4

Participants receive CAPDac regimen for 4 cycles (cycle length 21 days): (C) Cyclophosphamide IV 500 mg/m\^2 (A) Brentuximab vedotin 1.2 mg/kg IV (P) Prednisone 40 mg/40 mg/m\^2/day PO (Dac) Dacarbazine 250 mg/m\^2 IV

Cycle 6 - Grade 2

Participants receive CAPDac regimen for 4 cycles (cycle length 21 days): (C) Cyclophosphamide IV 500 mg/m\^2 (A) Brentuximab vedotin 1.2 mg/kg IV (P) Prednisone 40 mg/40 mg/m\^2/day PO (Dac) Dacarbazine 250 mg/m\^2 IV

Cycle 6 - Grade 3-4

Participants receive CAPDac regimen for 4 cycles (cycle length 21 days): (C) Cyclophosphamide IV 500 mg/m\^2 (A) Brentuximab vedotin 1.2 mg/kg IV (P) Prednisone 40 mg/40 mg/m\^2/day PO (Dac) Dacarbazine 250 mg/m\^2 IV

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

Analysis denominator · Participants

GroupSource count
Cycle 1 - Grade 277
Cycle 1 - Grade 3-477
Cycle 2 - Grade 277
Cycle 2 - Grade 3-477
Cycle 3 - Grade 277
Cycle 3 - Grade 3-477
Cycle 4 - Grade 276
Cycle 4 - Grade 3-476
Cycle 5 - Grade 276
Cycle 5 - Grade 3-476
Cycle 6 - Grade 276
Cycle 6 - Grade 3-476

Reported measurements

Febrile neutropenia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cycle 1 - Grade 20Not reportedNot reportedNot reportedNot reported
Cycle 1 - Grade 3-46Not reportedNot reportedNot reportedNot reported
Cycle 2 - Grade 20Not reportedNot reportedNot reportedNot reported
Cycle 2 - Grade 3-43Not reportedNot reportedNot reportedNot reported
Cycle 3 - Grade 20Not reportedNot reportedNot reportedNot reported
Cycle 3 - Grade 3-40Not reportedNot reportedNot reportedNot reported
Cycle 4 - Grade 20Not reportedNot reportedNot reportedNot reported
Cycle 4 - Grade 3-42Not reportedNot reportedNot reportedNot reported
Cycle 5 - Grade 20Not reportedNot reportedNot reportedNot reported
Cycle 5 - Grade 3-41Not reportedNot reportedNot reportedNot reported
Cycle 6 - Grade 20Not reportedNot reportedNot reportedNot reported
Cycle 6 - Grade 3-40Not reportedNot reportedNot reportedNot reported
Mucositis
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cycle 1 - Grade 210Not reportedNot reportedNot reportedNot reported
Cycle 1 - Grade 3-42Not reportedNot reportedNot reportedNot reported
Cycle 2 - Grade 26Not reportedNot reportedNot reportedNot reported
Cycle 2 - Grade 3-44Not reportedNot reportedNot reportedNot reported
Cycle 3 - Grade 20Not reportedNot reportedNot reportedNot reported
Cycle 3 - Grade 3-40Not reportedNot reportedNot reportedNot reported
Cycle 4 - Grade 21Not reportedNot reportedNot reportedNot reported
Cycle 4 - Grade 3-40Not reportedNot reportedNot reportedNot reported
Cycle 5 - Grade 21Not reportedNot reportedNot reportedNot reported
Cycle 5 - Grade 3-40Not reportedNot reportedNot reportedNot reported
Cycle 6 - Grade 21Not reportedNot reportedNot reportedNot reported
Cycle 6 - Grade 3-40Not reportedNot reportedNot reportedNot reported
Upper respiratory infection
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cycle 1 - Grade 25Not reportedNot reportedNot reportedNot reported
Cycle 1 - Grade 3-42Not reportedNot reportedNot reportedNot reported
Cycle 2 - Grade 23Not reportedNot reportedNot reportedNot reported
Cycle 2 - Grade 3-40Not reportedNot reportedNot reportedNot reported
Cycle 3 - Grade 20Not reportedNot reportedNot reportedNot reported
Cycle 3 - Grade 3-40Not reportedNot reportedNot reportedNot reported
Cycle 4 - Grade 20Not reportedNot reportedNot reportedNot reported
Cycle 4 - Grade 3-42Not reportedNot reportedNot reportedNot reported
Cycle 5 - Grade 20Not reportedNot reportedNot reportedNot reported
Cycle 5 - Grade 3-40Not reportedNot reportedNot reportedNot reported
Cycle 6 - Grade 20Not reportedNot reportedNot reportedNot reported
Cycle 6 - Grade 3-40Not reportedNot reportedNot reportedNot reported
Genitourinary infection
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cycle 1 - Grade 21Not reportedNot reportedNot reportedNot reported
Cycle 1 - Grade 3-40Not reportedNot reportedNot reportedNot reported
Cycle 2 - Grade 21Not reportedNot reportedNot reportedNot reported
Cycle 2 - Grade 3-40Not reportedNot reportedNot reportedNot reported
Cycle 3 - Grade 22Not reportedNot reportedNot reportedNot reported
Cycle 3 - Grade 3-40Not reportedNot reportedNot reportedNot reported
Cycle 4 - Grade 21Not reportedNot reportedNot reportedNot reported
Cycle 4 - Grade 3-40Not reportedNot reportedNot reportedNot reported
Cycle 5 - Grade 22Not reportedNot reportedNot reportedNot reported
Cycle 5 - Grade 3-40Not reportedNot reportedNot reportedNot reported
Cycle 6 - Grade 20Not reportedNot reportedNot reportedNot reported
Cycle 6 - Grade 3-40Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        6
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        3
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        0
      8. group Id
        OG007
        value
        2
      9. group Id
        OG008
        value
        0
      10. group Id
        OG009
        value
        1
      11. group Id
        OG010
        value
        0
      12. group Id
        OG011
        value
        0
    title
    Febrile neutropenia
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        10
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        6
      4. group Id
        OG003
        value
        4
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        1
      8. group Id
        OG007
        value
        0
      9. group Id
        OG008
        value
        1
      10. group Id
        OG009
        value
        0
      11. group Id
        OG010
        value
        1
      12. group Id
        OG011
        value
        0
    title
    Mucositis
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        3
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        0
      8. group Id
        OG007
        value
        2
      9. group Id
        OG008
        value
        0
      10. group Id
        OG009
        value
        0
      11. group Id
        OG010
        value
        0
      12. group Id
        OG011
        value
        0
    title
    Upper respiratory infection
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        2
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        1
      8. group Id
        OG007
        value
        0
      9. group Id
        OG008
        value
        2
      10. group Id
        OG009
        value
        0
      11. group Id
        OG010
        value
        0
      12. group Id
        OG011
        value
        0
    title
    Genitourinary infection
denoms
  1. counts
    1. group Id
      OG000
      value
      77
    2. group Id
      OG001
      value
      77
    3. group Id
      OG002
      value
      77
    4. group Id
      OG003
      value
      77
    5. group Id
      OG004
      value
      77
    6. group Id
      OG005
      value
      77
    7. group Id
      OG006
      value
      76
    8. group Id
      OG007
      value
      76
    9. group Id
      OG008
      value
      76
    10. group Id
      OG009
      value
      76
    11. group Id
      OG010
      value
      76
    12. group Id
      OG011
      value
      76
    units
    Participants
description
To describe acute hematologic, neuropathic, and infectious toxicities as they relate to transfusion requirements, growth factor support, episodes of febrile neutropenia and hospitalizations, according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 4.0.
groups
  1. description
    Participants receive AEPA regimen for 2 cycles (cycle length 28 days) (A) Brentuximab vedotin 1.2 mg/kg IV (E) Etoposide 125 mg/m\^2 IV (P) Prednisone 60 mg/m\^2/day PO (orally) (A) Doxorubicin 40 mg/m\^2 IV For those with lymph nodes that do not go into remission after 2 courses of AEPA chemotherapy, radiation therapy will be given.
    id
    OG000
    title
    Cycle 1 - Grade 2
  2. description
    Participants receive AEPA regimen for 2 cycles (cycle length 28 days) (A) Brentuximab vedotin 1.2 mg/kg IV (E) Etoposide 125 mg/m\^2 IV (P) Prednisone 60 mg/m\^2/day PO (orally) (A) Doxorubicin 40 mg/m\^2 IV For those with lymph nodes that do not go into remission after 2 courses of AEPA chemotherapy, radiation therapy will be given.
    id
    OG001
    title
    Cycle 1 - Grade 3-4
  3. description
    Participants receive AEPA regimen for 2 cycles (cycle length 28 days) (A) Brentuximab vedotin 1.2 mg/kg IV (E) Etoposide 125 mg/m\^2 IV (P) Prednisone 60 mg/m\^2/day PO (orally) (A) Doxorubicin 40 mg/m\^2 IV For those with lymph nodes that do not go into remission after 2 courses of AEPA chemotherapy, radiation therapy will be given.
    id
    OG002
    title
    Cycle 2 - Grade 2
  4. description
    Participants receive AEPA regimen for 2 cycles (cycle length 28 days) (A) Brentuximab vedotin 1.2 mg/kg IV (E) Etoposide 125 mg/m\^2 IV (P) Prednisone 60 mg/m\^2/day PO (orally) (A) Doxorubicin 40 mg/m\^2 IV For those with lymph nodes that do not go into remission after 2 courses of AEPA chemotherapy, radiation therapy will be given.
    id
    OG003
    title
    Cycle 2 - Grade 3-4
  5. description
    Participants receive CAPDac regimen for 4 cycles (cycle length 21 days): (C) Cyclophosphamide IV 500 mg/m\^2 (A) Brentuximab vedotin 1.2 mg/kg IV (P) Prednisone 40 mg/40 mg/m\^2/day PO (Dac) Dacarbazine 250 mg/m\^2 IV
    id
    OG004
    title
    Cycle 3 - Grade 2
  6. description
    Participants receive CAPDac regimen for 4 cycles (cycle length 21 days): (C) Cyclophosphamide IV 500 mg/m\^2 (A) Brentuximab vedotin 1.2 mg/kg IV (P) Prednisone 40 mg/40 mg/m\^2/day PO (Dac) Dacarbazine 250 mg/m\^2 IV
    id
    OG005
    title
    Cycle 3 - Grade 3-4
  7. description
    Participants receive CAPDac regimen for 4 cycles (cycle length 21 days): (C) Cyclophosphamide IV 500 mg/m\^2 (A) Brentuximab vedotin 1.2 mg/kg IV (P) Prednisone 40 mg/40 mg/m\^2/day PO (Dac) Dacarbazine 250 mg/m\^2 IV
    id
    OG006
    title
    Cycle 4 - Grade 2
  8. description
    Participants receive CAPDac regimen for 4 cycles (cycle length 21 days): (C) Cyclophosphamide IV 500 mg/m\^2 (A) Brentuximab vedotin 1.2 mg/kg IV (P) Prednisone 40 mg/40 mg/m\^2/day PO (Dac) Dacarbazine 250 mg/m\^2 IV
    id
    OG007
    title
    Cycle 4 - Grade 3-4
  9. description
    Participants receive CAPDac regimen for 4 cycles (cycle length 21 days): (C) Cyclophosphamide IV 500 mg/m\^2 (A) Brentuximab vedotin 1.2 mg/kg IV (P) Prednisone 40 mg/40 mg/m\^2/day PO (Dac) Dacarbazine 250 mg/m\^2 IV
    id
    OG008
    title
    Cycle 5 - Grade 2
  10. description
    Participants receive CAPDac regimen for 4 cycles (cycle length 21 days): (C) Cyclophosphamide IV 500 mg/m\^2 (A) Brentuximab vedotin 1.2 mg/kg IV (P) Prednisone 40 mg/40 mg/m\^2/day PO (Dac) Dacarbazine 250 mg/m\^2 IV
    id
    OG009
    title
    Cycle 5 - Grade 3-4
  11. description
    Participants receive CAPDac regimen for 4 cycles (cycle length 21 days): (C) Cyclophosphamide IV 500 mg/m\^2 (A) Brentuximab vedotin 1.2 mg/kg IV (P) Prednisone 40 mg/40 mg/m\^2/day PO (Dac) Dacarbazine 250 mg/m\^2 IV
    id
    OG010
    title
    Cycle 6 - Grade 2
  12. description
    Participants receive CAPDac regimen for 4 cycles (cycle length 21 days): (C) Cyclophosphamide IV 500 mg/m\^2 (A) Brentuximab vedotin 1.2 mg/kg IV (P) Prednisone 40 mg/40 mg/m\^2/day PO (Dac) Dacarbazine 250 mg/m\^2 IV
    id
    OG011
    title
    Cycle 6 - Grade 3-4
param Type
COUNT_OF_PARTICIPANTS
population Description
Toxicities reported below for the current study (HLHR13) include all reported infectious toxicities from a participant's on-study date through end of therapy.
reporting Status
POSTED
time Frame
From enrollment to end of therapy (approximately 8 months)
title
Descriptive of Infectious Adverse Events
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice