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NCT00822120 · OUTCOME

Number of HIV-positive Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug

S0816 Fludeoxyglucose F 18-PET/CT Imaging and Combination Chemotherapy With or Without Additional Chemotherapy and G-CSF in Treating Patients With Stage III or Stage IV Hodgkin Lymphoma · Source last updated 2022-08-18

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

Measure
NUMBER
Unit
Participants
Interval / dispersion
Not reported
Time frame
Up to 1 year

What was measured

Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.

Analysis population: Eligible HIV-positive patients who had received any treatment were included in the adverse event summaries. Any CTCAE 4.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which deemed to be related to protocol treatment are included.

Groups in this outcome

Initial ABVD

Doxorubicin 25 mg/m\^2 IV, Bleomycin 10u/m\^2 IV, Vinblastine 6mg/m\^2 IV, Dacarbazine 375 mg/m\^2 IV Days 1,15 Q 28 Days x 2 cycles

PET-negative: Continued ABVD

Doxorubicin 25 mg/m\^2 IV, Bleomycin 10u/m\^2 IV, Vinblastine 6mg/m\^2 IV, Dacarbazine 375 mg/m\^2 IV Days 1,15 Q 28 Days x 4 cycles

PET-positive: BEACOPP Standard

Etoposide 100 mg/m\^2 IV Days 1, 2, 3, Doxorubicin 25 mg/m\^2 IV Day 1, Cyclophosphamide 650 mg/m\^2 IV Day 1, Procarbzine 100 mg/m\^2 PO Days 1-7, Prednisone 40 mg/m\^2 PO Days 1-14, Bleomycin 10u/m\^2 IV Day 8, Vincristine 1.4 mg/m\^2 IV Day 8, Q 21 Days x 6 cycles

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

Analysis denominator · Participants

GroupSource count
Initial ABVD12
PET-negative: Continued ABVD10
PET-positive: BEACOPP Standard1

Reported measurements

Anorexia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Initial ABVD0Not reportedNot reportedNot reportedNot reported
PET-negative: Continued ABVD1Not reportedNot reportedNot reportedNot reported
PET-positive: BEACOPP Standard0Not reportedNot reportedNot reportedNot reported
Dizziness
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Initial ABVD0Not reportedNot reportedNot reportedNot reported
PET-negative: Continued ABVD1Not reportedNot reportedNot reportedNot reported
PET-positive: BEACOPP Standard0Not reportedNot reportedNot reportedNot reported
Fatigue (asthenia, lethargy, malaise)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Initial ABVD1Not reportedNot reportedNot reportedNot reported
PET-negative: Continued ABVD1Not reportedNot reportedNot reportedNot reported
PET-positive: BEACOPP Standard0Not reportedNot reportedNot reportedNot reported
Febrile neutropenia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Initial ABVD3Not reportedNot reportedNot reportedNot reported
PET-negative: Continued ABVD3Not reportedNot reportedNot reportedNot reported
PET-positive: BEACOPP Standard0Not reportedNot reportedNot reportedNot reported
Hemoglobin
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Initial ABVD1Not reportedNot reportedNot reportedNot reported
PET-negative: Continued ABVD3Not reportedNot reportedNot reportedNot reported
PET-positive: BEACOPP Standard1Not reportedNot reportedNot reportedNot reported
Inf (clin/microbio) w/Gr 3-4 neuts - Eye NOS
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Initial ABVD1Not reportedNot reportedNot reportedNot reported
PET-negative: Continued ABVD0Not reportedNot reportedNot reportedNot reported
PET-positive: BEACOPP Standard0Not reportedNot reportedNot reportedNot reported
Inf (clin/microbio) w/Gr 3-4 neuts - Lung
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Initial ABVD0Not reportedNot reportedNot reportedNot reported
PET-negative: Continued ABVD1Not reportedNot reportedNot reportedNot reported
PET-positive: BEACOPP Standard0Not reportedNot reportedNot reportedNot reported
Infection with unknown ANC - Urinary tract NOS
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Initial ABVD0Not reportedNot reportedNot reportedNot reported
PET-negative: Continued ABVD0Not reportedNot reportedNot reportedNot reported
PET-positive: BEACOPP Standard1Not reportedNot reportedNot reportedNot reported
Insomnia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Initial ABVD1Not reportedNot reportedNot reportedNot reported
PET-negative: Continued ABVD0Not reportedNot reportedNot reportedNot reported
PET-positive: BEACOPP Standard0Not reportedNot reportedNot reportedNot reported
Leukocytes (total WBC)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Initial ABVD7Not reportedNot reportedNot reportedNot reported
PET-negative: Continued ABVD6Not reportedNot reportedNot reportedNot reported
PET-positive: BEACOPP Standard1Not reportedNot reportedNot reportedNot reported
Lymphopenia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Initial ABVD1Not reportedNot reportedNot reportedNot reported
PET-negative: Continued ABVD2Not reportedNot reportedNot reportedNot reported
PET-positive: BEACOPP Standard1Not reportedNot reportedNot reportedNot reported
Mood alteration - agitation
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Initial ABVD1Not reportedNot reportedNot reportedNot reported
PET-negative: Continued ABVD0Not reportedNot reportedNot reportedNot reported
PET-positive: BEACOPP Standard0Not reportedNot reportedNot reportedNot reported
Mood alteration - anxiety
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Initial ABVD1Not reportedNot reportedNot reportedNot reported
PET-negative: Continued ABVD0Not reportedNot reportedNot reportedNot reported
PET-positive: BEACOPP Standard0Not reportedNot reportedNot reportedNot reported
Muscle weakness, not d/t neuropathy - body/general
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Initial ABVD1Not reportedNot reportedNot reportedNot reported
PET-negative: Continued ABVD0Not reportedNot reportedNot reportedNot reported
PET-positive: BEACOPP Standard0Not reportedNot reportedNot reportedNot reported
Neuropathy: motor
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Initial ABVD0Not reportedNot reportedNot reportedNot reported
PET-negative: Continued ABVD1Not reportedNot reportedNot reportedNot reported
PET-positive: BEACOPP Standard0Not reportedNot reportedNot reportedNot reported
Neuropathy: sensory
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Initial ABVD1Not reportedNot reportedNot reportedNot reported
PET-negative: Continued ABVD1Not reportedNot reportedNot reportedNot reported
PET-positive: BEACOPP Standard0Not reportedNot reportedNot reportedNot reported
Neutrophils/granulocytes (ANC/AGC)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Initial ABVD8Not reportedNot reportedNot reportedNot reported
PET-negative: Continued ABVD7Not reportedNot reportedNot reportedNot reported
PET-positive: BEACOPP Standard1Not reportedNot reportedNot reportedNot reported
Pain - Bone
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Initial ABVD1Not reportedNot reportedNot reportedNot reported
PET-negative: Continued ABVD0Not reportedNot reportedNot reportedNot reported
PET-positive: BEACOPP Standard0Not reportedNot reportedNot reportedNot reported
Pain - Joint
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Initial ABVD1Not reportedNot reportedNot reportedNot reported
PET-negative: Continued ABVD1Not reportedNot reportedNot reportedNot reported
PET-positive: BEACOPP Standard0Not reportedNot reportedNot reportedNot reported
Phosphate, serum-low (hypophosphatemia)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Initial ABVD1Not reportedNot reportedNot reportedNot reported
PET-negative: Continued ABVD1Not reportedNot reportedNot reportedNot reported
PET-positive: BEACOPP Standard0Not reportedNot reportedNot reportedNot reported
Platelets
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Initial ABVD0Not reportedNot reportedNot reportedNot reported
PET-negative: Continued ABVD1Not reportedNot reportedNot reportedNot reported
PET-positive: BEACOPP Standard0Not reportedNot reportedNot reportedNot reported
Sodium, serum-low (hyponatremia)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Initial ABVD1Not reportedNot reportedNot reportedNot reported
PET-negative: Continued ABVD0Not reportedNot reportedNot reportedNot reported
PET-positive: BEACOPP Standard0Not reportedNot reportedNot reportedNot reported
Thrombosis/thrombus/embolism
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Initial ABVD0Not reportedNot reportedNot reportedNot reported
PET-negative: Continued ABVD1Not reportedNot reportedNot reportedNot reported
PET-positive: BEACOPP Standard0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        0
    title
    Anorexia
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        0
    title
    Dizziness
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        0
    title
    Fatigue (asthenia, lethargy, malaise)
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        0
    title
    Febrile neutropenia
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        1
    title
    Hemoglobin
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    Inf (clin/microbio) w/Gr 3-4 neuts - Eye NOS
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        0
    title
    Inf (clin/microbio) w/Gr 3-4 neuts - Lung
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        1
    title
    Infection with unknown ANC - Urinary tract NOS
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    Insomnia
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        7
      2. group Id
        OG001
        value
        6
      3. group Id
        OG002
        value
        1
    title
    Leukocytes (total WBC)
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        1
    title
    Lymphopenia
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    Mood alteration - agitation
denoms
  1. counts
    1. group Id
      OG000
      value
      12
    2. group Id
      OG001
      value
      10
    3. group Id
      OG002
      value
      1
    units
    Participants
description
Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.
groups
  1. description
    Doxorubicin 25 mg/m\^2 IV, Bleomycin 10u/m\^2 IV, Vinblastine 6mg/m\^2 IV, Dacarbazine 375 mg/m\^2 IV Days 1,15 Q 28 Days x 2 cycles
    id
    OG000
    title
    Initial ABVD
  2. description
    Doxorubicin 25 mg/m\^2 IV, Bleomycin 10u/m\^2 IV, Vinblastine 6mg/m\^2 IV, Dacarbazine 375 mg/m\^2 IV Days 1,15 Q 28 Days x 4 cycles
    id
    OG001
    title
    PET-negative: Continued ABVD
  3. description
    Etoposide 100 mg/m\^2 IV Days 1, 2, 3, Doxorubicin 25 mg/m\^2 IV Day 1, Cyclophosphamide 650 mg/m\^2 IV Day 1, Procarbzine 100 mg/m\^2 PO Days 1-7, Prednisone 40 mg/m\^2 PO Days 1-14, Bleomycin 10u/m\^2 IV Day 8, Vincristine 1.4 mg/m\^2 IV Day 8, Q 21 Days x 6 cycles
    id
    OG002
    title
    PET-positive: BEACOPP Standard
param Type
NUMBER
population Description
Eligible HIV-positive patients who had received any treatment were included in the adverse event summaries. Any CTCAE 4.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which deemed to be related to protocol treatment are included.
reporting Status
POSTED
time Frame
Up to 1 year
title
Number of HIV-positive Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice