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NCT00109928 · OUTCOME

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

S0350 Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage II, Stage III, or Stage IV Peripheral T-Cell Non-Hodgkin's Lymphoma · Source last updated 2014-10-01

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 18 weeks of protocol treatment

What was measured

Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.

Analysis population: Eligible patients who had received any treatment were included in the adverse event summaries. Any CTCAE 3.0 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

PEGS

Patients received IV cisplatin 25 mg/m2 days 1 to 4, etoposide 40 mg/m2 days 1 to 4, gemcitabine 1000 mg/m2 day 1 and solumedrol 250 mg days 1 to 4 of a 21 day cycle for 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
PEGS33

Reported measurements

Albumin, serum-low (hypoalbuminemia)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PEGS1Not reportedNot reportedNot reportedNot reported
Allergic reaction/hypersensitivity
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PEGS1Not reportedNot reportedNot reportedNot reported
Anorexia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PEGS2Not reportedNot reportedNot reportedNot reported
Ataxia (incoordination)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PEGS1Not reportedNot reportedNot reportedNot reported
Auditory/Ear-Other (Specify)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PEGS1Not reportedNot reportedNot reportedNot reported
Blood/Bone Marrow-Other (Specify)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PEGS1Not reportedNot reportedNot reportedNot reported
Colitis, infectious (e.g., Clostridium difficile)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PEGS2Not reportedNot reportedNot reportedNot reported
Creatinine
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PEGS2Not reportedNot reportedNot reportedNot reported
Diarrhea
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PEGS2Not reportedNot reportedNot reportedNot reported
Dysphagia (difficulty swallowing)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PEGS1Not reportedNot reportedNot reportedNot reported
Dyspnea (shortness of breath)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PEGS1Not reportedNot reportedNot reportedNot reported
Fatigue (asthenia, lethargy, malaise)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PEGS2Not reportedNot reportedNot reportedNot reported
Febrile neutropenia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PEGS4Not reportedNot reportedNot reportedNot reported
Gastrointestinal-Other (Specify)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PEGS1Not reportedNot reportedNot reportedNot reported
Glucose, serum-high (hyperglycemia)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PEGS4Not reportedNot reportedNot reportedNot reported
Glucose, serum-low (hypoglycemia)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PEGS1Not reportedNot reportedNot reportedNot reported
Hemoglobin
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PEGS9Not reportedNot reportedNot reportedNot reported
Hemorrhage, CNS
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PEGS1Not reportedNot reportedNot reportedNot reported
Hypotension
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PEGS2Not reportedNot reportedNot reportedNot reported
Incontinence, anal
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PEGS1Not reportedNot reportedNot reportedNot reported
Inf (clin/microbio) w/Gr 3-4 neuts - Blood
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PEGS1Not reportedNot reportedNot reportedNot reported
Inf (clin/microbio) w/Gr 3-4 neuts - Colon
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PEGS1Not reportedNot reportedNot reportedNot reported
Inf w/normal ANC or Gr 1-2 neutrophils - Bladder
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PEGS1Not reportedNot reportedNot reportedNot reported
Inf w/normal ANC or Gr 1-2 neutrophils - Lung
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PEGS1Not reportedNot reportedNot reportedNot reported
Leukocytes (total WBC)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PEGS8Not reportedNot reportedNot reportedNot reported
Lymphopenia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PEGS7Not reportedNot reportedNot reportedNot reported
Magnesium, serum-low (hypomagnesemia)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PEGS2Not reportedNot reportedNot reportedNot reported
Nausea
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PEGS1Not reportedNot reportedNot reportedNot reported
Neurology-Other (Specify)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PEGS1Not reportedNot reportedNot reportedNot reported
Neuropathy: motor
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PEGS1Not reportedNot reportedNot reportedNot reported
Neuropathy: sensory
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PEGS2Not reportedNot reportedNot reportedNot reported
Neutrophils/granulocytes (ANC/AGC)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PEGS16Not reportedNot reportedNot reportedNot reported
Pain - Abdomen NOS
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PEGS1Not reportedNot reportedNot reportedNot reported
Platelets
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PEGS8Not reportedNot reportedNot reportedNot reported
Potassium, serum-low (hypokalemia)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PEGS1Not reportedNot reportedNot reportedNot reported
Renal failure
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PEGS2Not reportedNot reportedNot reportedNot reported
Sodium, serum-low (hyponatremia)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PEGS2Not reportedNot reportedNot reportedNot reported
Thrombotic microangiopathy
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PEGS1Not reportedNot reportedNot reportedNot reported
Tinnitus
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PEGS1Not reportedNot reportedNot reportedNot reported
Tumor lysis syndrome
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PEGS1Not reportedNot reportedNot reportedNot reported
Uric acid, serum-high (hyperuricemia)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PEGS1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Albumin, serum-low (hypoalbuminemia)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Allergic reaction/hypersensitivity
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Anorexia
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Ataxia (incoordination)
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Auditory/Ear-Other (Specify)
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Blood/Bone Marrow-Other (Specify)
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Colitis, infectious (e.g., Clostridium difficile)
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Creatinine
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Diarrhea
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Dysphagia (difficulty swallowing)
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Dyspnea (shortness of breath)
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Fatigue (asthenia, lethargy, malaise)
denoms
  1. counts
    1. group Id
      OG000
      value
      33
    units
    Participants
description
Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.
groups
  1. description
    Patients received IV cisplatin 25 mg/m2 days 1 to 4, etoposide 40 mg/m2 days 1 to 4, gemcitabine 1000 mg/m2 day 1 and solumedrol 250 mg days 1 to 4 of a 21 day cycle for 6 cycles.)
    id
    OG000
    title
    PEGS
param Type
NUMBER
population Description
Eligible patients who had received any treatment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which deemed to be related to protocol treatment are included.
time Frame
up to 18 weeks of protocol treatment
title
Number of 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-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice