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NCT00822120 · OUTCOME

Number of HIV-negative 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
COUNT_OF_PARTICIPANTS
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-negative patients who had received any treatment were included in the adverse event summaries. Six interim PET-positive patients who did not receive BEACOPP were excluded. patients 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

HIV-negative: 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

HIV-negative and 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

HIV-negative and PET-positive: BEACOPP Escalated

Etoposide 200 mg/m\^2 IV Days 1, 2, 3, Doxorubicin 35 mg/m\^2 IV Day 1, Cyclophosphamide 1,250 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, G-CSF 5mcg/kg/day SQ Days 8-14, 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
HIV-negative: Initial ABVD336
HIV-negative and PET-negative: Continued ABVD270
HIV-negative and PET-positive: BEACOPP Escalated49

Reported measurements

ALT, SGPT (serum glutamic pyruvic transaminase)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HIV-negative: Initial ABVD3Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-negative: Continued ABVD0Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-positive: BEACOPP Escalated0Not reportedNot reportedNot reportedNot reported
AST, SGOT
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HIV-negative: Initial ABVD1Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-negative: Continued ABVD0Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-positive: BEACOPP Escalated0Not reportedNot reportedNot reportedNot reported
Adult respiratory distress syndrome (ARDS)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HIV-negative: Initial ABVD0Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-negative: Continued ABVD2Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-positive: BEACOPP Escalated0Not reportedNot reportedNot reportedNot reported
Albumin, serum-low (hypoalbuminemia)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HIV-negative: Initial ABVD1Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-negative: Continued ABVD0Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-positive: BEACOPP Escalated0Not reportedNot reportedNot reportedNot reported
Alkaline phosphatase
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HIV-negative: Initial ABVD1Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-negative: Continued ABVD0Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-positive: BEACOPP Escalated0Not reportedNot reportedNot reportedNot reported
Allergic reaction/hypersensitivity
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HIV-negative: Initial ABVD2Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-negative: Continued ABVD2Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-positive: BEACOPP Escalated0Not reportedNot reportedNot reportedNot reported
Anorexia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HIV-negative: Initial ABVD1Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-negative: Continued ABVD1Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-positive: BEACOPP Escalated0Not reportedNot reportedNot reportedNot reported
Arthritis (non-septic)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HIV-negative: Initial ABVD1Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-negative: Continued ABVD0Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-positive: BEACOPP Escalated0Not reportedNot reportedNot reportedNot reported
Carbon monoxide diffusion capacity (DL(co))
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HIV-negative: Initial ABVD0Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-negative: Continued ABVD2Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-positive: BEACOPP Escalated0Not reportedNot reportedNot reportedNot reported
Colitis
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HIV-negative: Initial ABVD0Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-negative: Continued ABVD1Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-positive: BEACOPP Escalated0Not reportedNot reportedNot reportedNot reported
Colitis, infectious (e.g., Clostridium difficile)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HIV-negative: Initial ABVD1Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-negative: Continued ABVD0Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-positive: BEACOPP Escalated1Not reportedNot reportedNot reportedNot reported
Constipation
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HIV-negative: Initial ABVD1Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-negative: Continued ABVD0Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-positive: BEACOPP Escalated0Not reportedNot reportedNot reportedNot reported
Cough
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HIV-negative: Initial ABVD0Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-negative: Continued ABVD1Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-positive: BEACOPP Escalated0Not reportedNot reportedNot reportedNot reported
Creatinine
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HIV-negative: Initial ABVD0Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-negative: Continued ABVD0Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-positive: BEACOPP Escalated1Not reportedNot reportedNot reportedNot reported
Cytokine release syndrome/acute infusion reaction
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HIV-negative: Initial ABVD1Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-negative: Continued ABVD0Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-positive: BEACOPP Escalated0Not reportedNot reportedNot reportedNot reported
Dehydration
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HIV-negative: Initial ABVD1Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-negative: Continued ABVD2Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-positive: BEACOPP Escalated1Not reportedNot reportedNot reportedNot reported
Diarrhea
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HIV-negative: Initial ABVD0Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-negative: Continued ABVD1Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-positive: BEACOPP Escalated0Not reportedNot reportedNot reportedNot reported
Dizziness
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HIV-negative: Initial ABVD1Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-negative: Continued ABVD0Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-positive: BEACOPP Escalated1Not reportedNot reportedNot reportedNot reported
Dyspnea (shortness of breath)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HIV-negative: Initial ABVD4Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-negative: Continued ABVD9Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-positive: BEACOPP Escalated1Not reportedNot reportedNot reportedNot reported
FEV(1)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HIV-negative: Initial ABVD0Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-negative: Continued ABVD1Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-positive: BEACOPP Escalated0Not reportedNot reportedNot reportedNot reported
Fatigue (asthenia, lethargy, malaise)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HIV-negative: Initial ABVD10Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-negative: Continued ABVD15Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-positive: BEACOPP Escalated3Not reportedNot reportedNot reportedNot reported
Febrile neutropenia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HIV-negative: Initial ABVD8Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-negative: Continued ABVD17Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-positive: BEACOPP Escalated17Not reportedNot reportedNot reportedNot reported
Fever in absence of neutropenia, ANC lt1.0x10e9/L
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HIV-negative: Initial ABVD0Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-negative: Continued ABVD3Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-positive: BEACOPP Escalated1Not reportedNot reportedNot reportedNot reported
Glucose, serum-high (hyperglycemia)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HIV-negative: Initial ABVD0Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-negative: Continued ABVD1Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-positive: BEACOPP Escalated1Not reportedNot reportedNot reportedNot reported
Heartburn/dyspepsia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HIV-negative: Initial ABVD1Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-negative: Continued ABVD0Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-positive: BEACOPP Escalated0Not reportedNot reportedNot reportedNot reported
Hemoglobin
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HIV-negative: Initial ABVD10Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-negative: Continued ABVD4Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-positive: BEACOPP Escalated37Not reportedNot reportedNot reportedNot reported
Hemolysis
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HIV-negative: Initial ABVD0Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-negative: Continued ABVD0Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-positive: BEACOPP Escalated1Not reportedNot reportedNot reportedNot reported
Hemorrhage, pulmonary/upper respiratory - Nose
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HIV-negative: Initial ABVD0Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-negative: Continued ABVD0Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-positive: BEACOPP Escalated1Not reportedNot reportedNot reportedNot reported
Hypotension
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HIV-negative: Initial ABVD0Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-negative: Continued ABVD0Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-positive: BEACOPP Escalated1Not reportedNot reportedNot reportedNot reported
Hypoxia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HIV-negative: Initial ABVD0Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-negative: Continued ABVD3Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-positive: BEACOPP Escalated1Not reportedNot reportedNot reportedNot reported
Inf (clin/microbio) w/Gr 3-4 neuts - Blood
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HIV-negative: Initial ABVD2Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-negative: Continued ABVD1Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-positive: BEACOPP Escalated2Not reportedNot reportedNot reportedNot reported
Inf (clin/microbio) w/Gr 3-4 neuts - Colon
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HIV-negative: Initial ABVD0Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-negative: Continued ABVD0Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-positive: BEACOPP Escalated1Not reportedNot reportedNot reportedNot reported
Inf (clin/microbio) w/Gr 3-4 neuts - Lung
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HIV-negative: Initial ABVD0Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-negative: Continued ABVD4Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-positive: BEACOPP Escalated2Not reportedNot reportedNot reportedNot reported
Inf (clin/microbio) w/Gr 3-4 neuts - Meninges
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HIV-negative: Initial ABVD1Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-negative: Continued ABVD0Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-positive: BEACOPP Escalated0Not reportedNot reportedNot reportedNot reported
Inf (clin/microbio) w/Gr 3-4 neuts - Mucosa
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HIV-negative: Initial ABVD1Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-negative: Continued ABVD0Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-positive: BEACOPP Escalated0Not reportedNot reportedNot reportedNot reported
Inf (clin/microbio) w/Gr 3-4 neuts - Skin
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HIV-negative: Initial ABVD0Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-negative: Continued ABVD1Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-positive: BEACOPP Escalated3Not reportedNot reportedNot reportedNot reported
Inf (clin/microbio) w/Gr 3-4 neuts - Soft tissue
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HIV-negative: Initial ABVD0Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-negative: Continued ABVD1Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-positive: BEACOPP Escalated0Not reportedNot reportedNot reportedNot reported
Inf (clin/microbio) w/Gr 3-4 neuts - UTI
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HIV-negative: Initial ABVD0Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-negative: Continued ABVD1Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-positive: BEACOPP Escalated1Not reportedNot reportedNot reportedNot reported
Inf (clin/microbio) w/Gr 3-4 neuts - Upper airway
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HIV-negative: Initial ABVD0Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-negative: Continued ABVD1Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-positive: BEACOPP Escalated1Not reportedNot reportedNot reportedNot reported
Inf (clin/microbio) w/Gr 3-4 neuts - Vagina
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HIV-negative: Initial ABVD1Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-negative: Continued ABVD0Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-positive: BEACOPP Escalated0Not reportedNot reportedNot reportedNot reported
Inf w/normal ANC or Gr 1-2 neutrophils - Catheter
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HIV-negative: Initial ABVD1Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-negative: Continued ABVD0Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-positive: BEACOPP Escalated0Not reportedNot reportedNot reportedNot reported
Inf w/normal ANC or Gr 1-2 neutrophils - Lung
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HIV-negative: Initial ABVD1Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-negative: Continued ABVD3Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-positive: BEACOPP Escalated0Not reportedNot reportedNot reportedNot reported
Inf w/normal ANC or Gr 1-2 neutrophils - Oral cav
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HIV-negative: Initial ABVD0Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-negative: Continued ABVD0Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-positive: BEACOPP Escalated1Not reportedNot reportedNot reportedNot reported
Inf w/normal ANC or Gr 1-2 neutrophils - Skin
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HIV-negative: Initial ABVD1Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-negative: Continued ABVD0Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-positive: BEACOPP Escalated1Not reportedNot reportedNot reportedNot reported
Infection with normal ANC or Grade 1 or 2 neutroph
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HIV-negative: Initial ABVD1Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-negative: Continued ABVD0Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-positive: BEACOPP Escalated0Not reportedNot reportedNot reportedNot reported
Infection with unknown ANC - Lung (pneumonia)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HIV-negative: Initial ABVD0Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-negative: Continued ABVD1Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-positive: BEACOPP Escalated0Not reportedNot reportedNot reportedNot reported
Left ventricular systolic dysfunction
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HIV-negative: Initial ABVD0Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-negative: Continued ABVD1Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-positive: BEACOPP Escalated0Not reportedNot reportedNot reportedNot reported
Leukocytes (total WBC)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HIV-negative: Initial ABVD73Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-negative: Continued ABVD86Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-positive: BEACOPP Escalated42Not reportedNot reportedNot reportedNot reported
Lymphopenia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HIV-negative: Initial ABVD15Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-negative: Continued ABVD30Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-positive: BEACOPP Escalated32Not reportedNot reportedNot reportedNot reported
Metabolic/Laboratory-Other (Specify)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HIV-negative: Initial ABVD1Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-negative: Continued ABVD0Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-positive: BEACOPP Escalated0Not reportedNot reportedNot reportedNot reported
Mood alteration - agitation
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HIV-negative: Initial ABVD1Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-negative: Continued ABVD0Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-positive: BEACOPP Escalated0Not reportedNot reportedNot reportedNot reported
Mood alteration - anxiety
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HIV-negative: Initial ABVD1Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-negative: Continued ABVD0Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-positive: BEACOPP Escalated0Not reportedNot reportedNot reportedNot reported
Mood alteration - depression
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HIV-negative: Initial ABVD1Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-negative: Continued ABVD0Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-positive: BEACOPP Escalated0Not reportedNot reportedNot reportedNot reported
Mucositis/stomatitis (clinical exam) - Oral cavity
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HIV-negative: Initial ABVD1Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-negative: Continued ABVD0Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-positive: BEACOPP Escalated2Not reportedNot reportedNot reportedNot reported
Mucositis/stomatitis (functional/symp) - Oral cav
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HIV-negative: Initial ABVD1Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-negative: Continued ABVD0Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-positive: BEACOPP Escalated1Not reportedNot reportedNot reportedNot reported
Muscle weakness, not d/t neuropathy - body/general
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HIV-negative: Initial ABVD0Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-negative: Continued ABVD0Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-positive: BEACOPP Escalated1Not reportedNot reportedNot reportedNot reported
Musculoskeletal/Soft Tissue-Other (Specify)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HIV-negative: Initial ABVD0Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-negative: Continued ABVD1Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-positive: BEACOPP Escalated0Not reportedNot reportedNot reportedNot reported
Nausea
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HIV-negative: Initial ABVD7Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-negative: Continued ABVD5Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-positive: BEACOPP Escalated2Not reportedNot reportedNot reportedNot reported
Neuropathy: motor
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HIV-negative: Initial ABVD2Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-negative: Continued ABVD3Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-positive: BEACOPP Escalated0Not reportedNot reportedNot reportedNot reported
Neuropathy: sensory
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HIV-negative: Initial ABVD4Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-negative: Continued ABVD12Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-positive: BEACOPP Escalated4Not reportedNot reportedNot reportedNot reported
Neutrophils/granulocytes (ANC/AGC)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HIV-negative: Initial ABVD206Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-negative: Continued ABVD165Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-positive: BEACOPP Escalated38Not reportedNot reportedNot reportedNot reported
Osteonecrosis (avascular necrosis)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HIV-negative: Initial ABVD0Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-negative: Continued ABVD0Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-positive: BEACOPP Escalated1Not reportedNot reportedNot reportedNot reported
Pain - Abdomen NOS
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HIV-negative: Initial ABVD2Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-negative: Continued ABVD5Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-positive: BEACOPP Escalated1Not reportedNot reportedNot reportedNot reported
Pain - Back
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HIV-negative: Initial ABVD1Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-negative: Continued ABVD0Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-positive: BEACOPP Escalated3Not reportedNot reportedNot reportedNot reported
Pain - Bone
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HIV-negative: Initial ABVD0Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-negative: Continued ABVD0Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-positive: BEACOPP Escalated5Not reportedNot reportedNot reportedNot reported
Pain - Cardiac/heart
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HIV-negative: Initial ABVD0Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-negative: Continued ABVD1Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-positive: BEACOPP Escalated0Not reportedNot reportedNot reportedNot reported
Pain - Chest wall
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HIV-negative: Initial ABVD1Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-negative: Continued ABVD1Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-positive: BEACOPP Escalated0Not reportedNot reportedNot reportedNot reported
Pain - Chest/thorax NOS
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HIV-negative: Initial ABVD0Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-negative: Continued ABVD1Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-positive: BEACOPP Escalated1Not reportedNot reportedNot reportedNot reported
Pain - Extremity-limb
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HIV-negative: Initial ABVD1Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-negative: Continued ABVD0Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-positive: BEACOPP Escalated0Not reportedNot reportedNot reportedNot reported
Pain - Head/headache
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HIV-negative: Initial ABVD2Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-negative: Continued ABVD2Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-positive: BEACOPP Escalated0Not reportedNot reportedNot reportedNot reported
Pain - Joint
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HIV-negative: Initial ABVD1Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-negative: Continued ABVD0Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-positive: BEACOPP Escalated1Not reportedNot reportedNot reportedNot reported
Pain - Muscle
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HIV-negative: Initial ABVD1Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-negative: Continued ABVD1Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-positive: BEACOPP Escalated0Not reportedNot reportedNot reportedNot reported
Pain - Oral cavity
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HIV-negative: Initial ABVD1Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-negative: Continued ABVD0Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-positive: BEACOPP Escalated0Not reportedNot reportedNot reportedNot reported
Pain - Skin
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HIV-negative: Initial ABVD0Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-negative: Continued ABVD1Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-positive: BEACOPP Escalated0Not reportedNot reportedNot reportedNot reported
Pain - Stomach
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HIV-negative: Initial ABVD0Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-negative: Continued ABVD1Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-positive: BEACOPP Escalated0Not reportedNot reportedNot reportedNot reported
Pain - Throat/pharynx/larynx
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HIV-negative: Initial ABVD0Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-negative: Continued ABVD0Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-positive: BEACOPP Escalated1Not reportedNot reportedNot reportedNot reported
Pain - Tumor pain
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HIV-negative: Initial ABVD1Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-negative: Continued ABVD0Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-positive: BEACOPP Escalated0Not reportedNot reportedNot reportedNot reported
Pain-Other (Specify)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HIV-negative: Initial ABVD1Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-negative: Continued ABVD2Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-positive: BEACOPP Escalated0Not reportedNot reportedNot reportedNot reported
Pancreatic endocrine: glucose intolerance
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HIV-negative: Initial ABVD1Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-negative: Continued ABVD1Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-positive: BEACOPP Escalated0Not reportedNot reportedNot reportedNot reported
Phosphate, serum-low (hypophosphatemia)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HIV-negative: Initial ABVD1Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-negative: Continued ABVD0Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-positive: BEACOPP Escalated0Not reportedNot reportedNot reportedNot reported
Platelets
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HIV-negative: Initial ABVD1Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-negative: Continued ABVD0Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-positive: BEACOPP Escalated34Not reportedNot reportedNot reportedNot reported
Pneumonitis/pulmonary infiltrates
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HIV-negative: Initial ABVD1Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-negative: Continued ABVD4Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-positive: BEACOPP Escalated1Not reportedNot reportedNot reportedNot reported
Potassium, serum-high (hyperkalemia)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HIV-negative: Initial ABVD0Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-negative: Continued ABVD0Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-positive: BEACOPP Escalated1Not reportedNot reportedNot reportedNot reported
Potassium, serum-low (hypokalemia)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HIV-negative: Initial ABVD0Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-negative: Continued ABVD0Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-positive: BEACOPP Escalated4Not reportedNot reportedNot reportedNot reported
Rash/desquamation
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HIV-negative: Initial ABVD1Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-negative: Continued ABVD0Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-positive: BEACOPP Escalated0Not reportedNot reportedNot reportedNot reported
Rigors/chills
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HIV-negative: Initial ABVD1Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-negative: Continued ABVD0Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-positive: BEACOPP Escalated2Not reportedNot reportedNot reportedNot reported
Sodium, serum-low (hyponatremia)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HIV-negative: Initial ABVD1Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-negative: Continued ABVD0Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-positive: BEACOPP Escalated1Not reportedNot reportedNot reportedNot reported
Syncope (fainting)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HIV-negative: Initial ABVD1Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-negative: Continued ABVD0Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-positive: BEACOPP Escalated1Not reportedNot reportedNot reportedNot reported
Thrombosis/thrombus/embolism
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HIV-negative: Initial ABVD2Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-negative: Continued ABVD5Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-positive: BEACOPP Escalated0Not reportedNot reportedNot reportedNot reported
Vomiting
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HIV-negative: Initial ABVD5Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-negative: Continued ABVD4Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-positive: BEACOPP Escalated0Not reportedNot reportedNot reportedNot reported
Weight gain
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HIV-negative: Initial ABVD0Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-negative: Continued ABVD2Not reportedNot reportedNot reportedNot reported
HIV-negative and PET-positive: BEACOPP Escalated0Not reportedNot reportedNot reportedNot reported
Complete source fields
calculate Pct
false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    ALT, SGPT (serum glutamic pyruvic transaminase)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    AST, SGOT
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        0
    title
    Adult respiratory distress syndrome (ARDS)
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    Albumin, serum-low (hypoalbuminemia)
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    Alkaline phosphatase
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        0
    title
    Allergic reaction/hypersensitivity
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        0
    title
    Anorexia
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    Arthritis (non-septic)
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        0
    title
    Carbon monoxide diffusion capacity (DL(co))
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        0
    title
    Colitis
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        1
    title
    Colitis, infectious (e.g., Clostridium difficile)
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    Constipation
denoms
  1. counts
    1. group Id
      OG000
      value
      336
    2. group Id
      OG001
      value
      270
    3. group Id
      OG002
      value
      49
    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
    HIV-negative: 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
    HIV-negative and PET-negative: Continued ABVD
  3. description
    Etoposide 200 mg/m\^2 IV Days 1, 2, 3, Doxorubicin 35 mg/m\^2 IV Day 1, Cyclophosphamide 1,250 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, G-CSF 5mcg/kg/day SQ Days 8-14, Q 21 Days x 6 cycles
    id
    OG002
    title
    HIV-negative and PET-positive: BEACOPP Escalated
param Type
COUNT_OF_PARTICIPANTS
population Description
Eligible HIV-negative patients who had received any treatment were included in the adverse event summaries. Six interim PET-positive patients who did not receive BEACOPP were excluded. patients 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-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
type
SECONDARY
unit Of Measure
Participants

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Preserved source evidence · Not medical advice