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NCT01044433 · OUTCOME

Number of Participants With Adverse Events and Serious Adverse Events

Capecitabine and Lapatinib Ditosylate in Treating Patients With Squamous Cell Cancer of the Head and Neck · Source last updated 2020-03-19

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
5 years

What was measured

ADVERSE EVENTS (AE) AND SERIOUS ADVERSE EVENTS (SAE) Adverse Events (AEs) will use the descriptions and grading scales found in the NCI CTCAE v3.0

Groups in this outcome

Arm I

Patients receive oral lapatinib ditosylate once daily on days 1-21 and oral capecitabine twice daily on days 1-14. lapatinib ditosylate: Given orally capecitabine: Given orally

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

Analysis denominator · Participants

GroupSource count
Arm I44

Reported measurements

Diarrhea
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I31Not reportedNot reportedNot reportedNot reported
Rash
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I31Not reportedNot reportedNot reportedNot reported
Pain
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I26Not reportedNot reportedNot reportedNot reported
Fatigue
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I23Not reportedNot reportedNot reportedNot reported
Infection
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I19Not reportedNot reportedNot reportedNot reported
Nausea
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I19Not reportedNot reportedNot reportedNot reported
Mucositis
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I14Not reportedNot reportedNot reportedNot reported
Vomiting
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I13Not reportedNot reportedNot reportedNot reported
Constipation
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I10Not reportedNot reportedNot reportedNot reported
Hand-foot syndrome
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I8Not reportedNot reportedNot reportedNot reported
Cough
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I7Not reportedNot reportedNot reportedNot reported
Acute kidney injury
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I6Not reportedNot reportedNot reportedNot reported
Dry skin
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I6Not reportedNot reportedNot reportedNot reported
Anorexia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I6Not reportedNot reportedNot reportedNot reported
Dehydration
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I5Not reportedNot reportedNot reportedNot reported
Edema of limb
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I5Not reportedNot reportedNot reportedNot reported
Heartburn
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I5Not reportedNot reportedNot reportedNot reported
Hyponatremia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I5Not reportedNot reportedNot reportedNot reported
Neuropathy
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I5Not reportedNot reportedNot reportedNot reported
Neutropenia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I2Not reportedNot reportedNot reportedNot reported
Febrile
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        31
    title
    Diarrhea
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        31
    title
    Rash
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        26
    title
    Pain
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        23
    title
    Fatigue
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        19
    title
    Infection
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        19
    title
    Nausea
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        14
    title
    Mucositis
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        13
    title
    Vomiting
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        10
    title
    Constipation
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        8
    title
    Hand-foot syndrome
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        7
    title
    Cough
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        6
    title
    Acute kidney injury
denoms
  1. counts
    1. group Id
      OG000
      value
      44
    units
    Participants
description
ADVERSE EVENTS (AE) AND SERIOUS ADVERSE EVENTS (SAE) Adverse Events (AEs) will use the descriptions and grading scales found in the NCI CTCAE v3.0
groups
  1. description
    Patients receive oral lapatinib ditosylate once daily on days 1-21 and oral capecitabine twice daily on days 1-14. lapatinib ditosylate: Given orally capecitabine: Given orally
    id
    OG000
    title
    Arm I
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
5 years
title
Number of Participants With Adverse Events and Serious Adverse Events
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice