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NCT00997243 · OUTCOME

Toxicities of the Combination

Azacitidine and Lintuzumab in Treating Patients With Previously Untreated Myelodysplastic Syndromes · Source last updated 2017-05-10

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

Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
Not reported
Time frame
up to 5 years

What was measured

All patients who received study drug were closely monitored for adverse events (AEs). All AEs that occured during study period were reported and the investigator determined the severity and relationship to study drug (unrelated, unlikely, possibly, probably, or definitely related). The NCI's CTCAE(Common Toxicity Criteria for Adverse Effects)v3.0 was used for grading AEs.

Groups in this outcome

5-azacytidine and Lintuzumab

Cycle 1- 5-azacytidine (Vidaza, AZA) 75mg/m2 IV/SC daily on days 1-7. Subsequent Cycles (cycles to be repeated every 28 days) AZA 75mg/m2 IV/SC daily on days 1-7.

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

Analysis denominator · Participants

GroupSource count
5-azacytidine and Lintuzumab7

Reported measurements

Thrombosis/embolism (vascular access-related)
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
5-azacytidine and Lintuzumab14Not reportedNot reportedNot reportedNot reported
Platelets
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
5-azacytidine and Lintuzumab100Not reportedNot reportedNot reportedNot reported
Neutrophils/granulocytes (ANC/AGC)
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
5-azacytidine and Lintuzumab100Not reportedNot reportedNot reportedNot reported
Lymphopenia
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
5-azacytidine and Lintuzumab57Not reportedNot reportedNot reportedNot reported
Leukocytes (total WBC)
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
5-azacytidine and Lintuzumab100Not reportedNot reportedNot reportedNot reported
Infection with unknown ANC - Upper airway NOS
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
5-azacytidine and Lintuzumab14Not reportedNot reportedNot reportedNot reported
Infection with normal ANC or Grade 1 or 2 neutroph
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
5-azacytidine and Lintuzumab14Not reportedNot reportedNot reportedNot reported
Infection with unknown ANC - Bladder (urinary)
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
5-azacytidine and Lintuzumab14Not reportedNot reportedNot reportedNot reported
Infection
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
5-azacytidine and Lintuzumab28Not reportedNot reportedNot reportedNot reported
Infection Grade 3 or 4 neutrophils-blood
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
5-azacytidine and Lintuzumab28Not reportedNot reportedNot reportedNot reported
Hemorrhage, GI (lower GI NOS/Rectum)
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
5-azacytidine and Lintuzumab14Not reportedNot reportedNot reportedNot reported
Hemorrhage/Bleeding - Other
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
5-azacytidine and Lintuzumab14Not reportedNot reportedNot reportedNot reported
Hemoglobin
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
5-azacytidine and Lintuzumab100Not reportedNot reportedNot reportedNot reported
Fever (in the absence of neutropenia)
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
5-azacytidine and Lintuzumab28Not reportedNot reportedNot reportedNot reported
Febrile neutropenia (fever of unknown origin)
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
5-azacytidine and Lintuzumab14Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        14
    title
    Thrombosis/embolism (vascular access-related)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        100
    title
    Platelets
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        100
    title
    Neutrophils/granulocytes (ANC/AGC)
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        57
    title
    Lymphopenia
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        100
    title
    Leukocytes (total WBC)
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        14
    title
    Infection with unknown ANC - Upper airway NOS
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        14
    title
    Infection with normal ANC or Grade 1 or 2 neutroph
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        14
    title
    Infection with unknown ANC - Bladder (urinary)
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        28
    title
    Infection
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        28
    title
    Infection Grade 3 or 4 neutrophils-blood
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        14
    title
    Hemorrhage, GI (lower GI NOS/Rectum)
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        14
    title
    Hemorrhage/Bleeding - Other
denoms
  1. counts
    1. group Id
      OG000
      value
      7
    units
    Participants
description
All patients who received study drug were closely monitored for adverse events (AEs). All AEs that occured during study period were reported and the investigator determined the severity and relationship to study drug (unrelated, unlikely, possibly, probably, or definitely related). The NCI's CTCAE(Common Toxicity Criteria for Adverse Effects)v3.0 was used for grading AEs.
groups
  1. description
    Cycle 1- 5-azacytidine (Vidaza, AZA) 75mg/m2 IV/SC daily on days 1-7. Subsequent Cycles (cycles to be repeated every 28 days) AZA 75mg/m2 IV/SC daily on days 1-7.
    id
    OG000
    title
    5-azacytidine and Lintuzumab
param Type
NUMBER
reporting Status
POSTED
time Frame
up to 5 years
title
Toxicities of the Combination
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice