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NCT00337129 · OUTCOME

Participants With a Given Type of AE

S0618 E7389 in Treating Patients With Metastatic or Recurrent Head and Neck Cancer · Source last updated 2015-08-25

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
Every 3 weeks while on protocol therapy, up to 3 years.

What was measured

The NCI Common Toxicity Criteria for Adverse Events (CTCAE) version 3.0 was utilized.

Analysis population: All eligible patients who started protocol treatment are included in analysis of toxicity

Groups in this outcome

Treatment (E7389 IV)

Patients receive E7389 IV on days 1 and 8 of an every 21-day cycle.

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

Analysis denominator · Participants

GroupSource count
Treatment (E7389 IV)40

Reported measurements

Dehydration
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (E7389 IV)1Not reportedNot reportedNot reportedNot reported
Diarrhea
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (E7389 IV)2Not reportedNot reportedNot reportedNot reported
Dry mouth/salivary gland (xerostomia)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (E7389 IV)1Not reportedNot reportedNot reportedNot reported
Dyspnea (shortness of breath)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (E7389 IV)2Not reportedNot reportedNot reportedNot reported
Fatigue (asthenia, lethargy, malaise)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (E7389 IV)2Not reportedNot reportedNot reportedNot reported
Glucose, serum-high (hyperglycemia)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (E7389 IV)1Not reportedNot reportedNot reportedNot reported
Hemoglobin
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (E7389 IV)1Not reportedNot reportedNot reportedNot reported
Hemorrhage - Bronchopulmonary NOS
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (E7389 IV)1Not reportedNot reportedNot reportedNot reported
Infection w/ Grade 3/4 ANC - Skin (cellulitis)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (E7389 IV)1Not reportedNot reportedNot reportedNot reported
Infection w unk ANC - gums (gingivitis)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (E7389 IV)1Not reportedNot reportedNot reportedNot reported
Leukocytes (total WBC)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (E7389 IV)5Not reportedNot reportedNot reportedNot reported
Lymphopenia
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (E7389 IV)6Not reportedNot reportedNot reportedNot reported
Mucositis - gums (gingivitis)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (E7389 IV)1Not reportedNot reportedNot reportedNot reported
Neuropathy: sensory
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (E7389 IV)1Not reportedNot reportedNot reportedNot reported
Neutrophils/granulocytes (ANC/AGC)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (E7389 IV)4Not reportedNot reportedNot reportedNot reported
Pneumonitis/pulmonary infiltrates
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (E7389 IV)1Not reportedNot reportedNot reportedNot reported
Potassium, serum-low (hypokalemia)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (E7389 IV)1Not reportedNot reportedNot reportedNot reported
Sodium, serum-low (hyponatremia)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (E7389 IV)2Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Dehydration
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Diarrhea
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Dry mouth/salivary gland (xerostomia)
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Dyspnea (shortness of breath)
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Fatigue (asthenia, lethargy, malaise)
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Glucose, serum-high (hyperglycemia)
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Hemoglobin
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Hemorrhage - Bronchopulmonary NOS
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Infection w/ Grade 3/4 ANC - Skin (cellulitis)
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Infection w unk ANC - gums (gingivitis)
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        5
    title
    Leukocytes (total WBC)
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        6
    title
    Lymphopenia
denoms
  1. counts
    1. group Id
      OG000
      value
      40
    units
    Participants
description
The NCI Common Toxicity Criteria for Adverse Events (CTCAE) version 3.0 was utilized.
groups
  1. description
    Patients receive E7389 IV on days 1 and 8 of an every 21-day cycle.
    id
    OG000
    title
    Treatment (E7389 IV)
param Type
NUMBER
population Description
All eligible patients who started protocol treatment are included in analysis of toxicity
reporting Status
POSTED
time Frame
Every 3 weeks while on protocol therapy, up to 3 years.
title
Participants With a Given Type of AE
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice