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NCT01064648 · OUTCOME

(Phase I) Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs

Pemetrexed Disodium and Cisplatin With or Without Cediranib Maleate in Treating Patients With Malignant Pleural Mesothelioma · Source last updated 2026-09-09

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
Toxicity assessment is repeated weekly during first cycle (1cycle = 21 days), then every cycle while patient is on treatment.

What was measured

Adverse Events (AEs) are reported by CTCAE Version 4.0. Only adverse events that are possibly, probably or definitely related to study drug are reported.

Analysis population: Patients who received at least one dose of protocol treatment.

Groups in this outcome

Phase I Cisplatin-pemetrexed Cediranib 30mg

Phase I Cisplatin-pemetrexed Cediranib 30mg

Phase I Cisplatin-pemetrexed Cediranib 20mg

Phase I Cisplatin-pemetrexed Cediranib 20mg

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

Analysis denominator · Participants

GroupSource count
Phase I Cisplatin-pemetrexed Cediranib 30mg7
Phase I Cisplatin-pemetrexed Cediranib 20mg13

Reported measurements

Abdominal pain
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase I Cisplatin-pemetrexed Cediranib 30mg0Not reportedNot reportedNot reportedNot reported
Phase I Cisplatin-pemetrexed Cediranib 20mg2Not reportedNot reportedNot reportedNot reported
Anemia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase I Cisplatin-pemetrexed Cediranib 30mg0Not reportedNot reportedNot reportedNot reported
Phase I Cisplatin-pemetrexed Cediranib 20mg1Not reportedNot reportedNot reportedNot reported
Constipation
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase I Cisplatin-pemetrexed Cediranib 30mg0Not reportedNot reportedNot reportedNot reported
Phase I Cisplatin-pemetrexed Cediranib 20mg1Not reportedNot reportedNot reportedNot reported
Dehydration
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase I Cisplatin-pemetrexed Cediranib 30mg0Not reportedNot reportedNot reportedNot reported
Phase I Cisplatin-pemetrexed Cediranib 20mg3Not reportedNot reportedNot reportedNot reported
Diarrhea
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase I Cisplatin-pemetrexed Cediranib 30mg2Not reportedNot reportedNot reportedNot reported
Phase I Cisplatin-pemetrexed Cediranib 20mg2Not reportedNot reportedNot reportedNot reported
Dyspnea
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase I Cisplatin-pemetrexed Cediranib 30mg0Not reportedNot reportedNot reportedNot reported
Phase I Cisplatin-pemetrexed Cediranib 20mg2Not reportedNot reportedNot reportedNot reported
Fatigue
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase I Cisplatin-pemetrexed Cediranib 30mg2Not reportedNot reportedNot reportedNot reported
Phase I Cisplatin-pemetrexed Cediranib 20mg1Not reportedNot reportedNot reportedNot reported
Gastrointestinal disorders - Other, specify
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase I Cisplatin-pemetrexed Cediranib 30mg0Not reportedNot reportedNot reportedNot reported
Phase I Cisplatin-pemetrexed Cediranib 20mg1Not reportedNot reportedNot reportedNot reported
Heart failure
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase I Cisplatin-pemetrexed Cediranib 30mg0Not reportedNot reportedNot reportedNot reported
Phase I Cisplatin-pemetrexed Cediranib 20mg1Not reportedNot reportedNot reportedNot reported
Hypertension
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase I Cisplatin-pemetrexed Cediranib 30mg0Not reportedNot reportedNot reportedNot reported
Phase I Cisplatin-pemetrexed Cediranib 20mg1Not reportedNot reportedNot reportedNot reported
Hypokalemia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase I Cisplatin-pemetrexed Cediranib 30mg0Not reportedNot reportedNot reportedNot reported
Phase I Cisplatin-pemetrexed Cediranib 20mg1Not reportedNot reportedNot reportedNot reported
Hypomagnesemia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase I Cisplatin-pemetrexed Cediranib 30mg1Not reportedNot reportedNot reportedNot reported
Phase I Cisplatin-pemetrexed Cediranib 20mg0Not reportedNot reportedNot reportedNot reported
Hyponatremia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase I Cisplatin-pemetrexed Cediranib 30mg0Not reportedNot reportedNot reportedNot reported
Phase I Cisplatin-pemetrexed Cediranib 20mg1Not reportedNot reportedNot reportedNot reported
Irregular menstruation
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase I Cisplatin-pemetrexed Cediranib 30mg0Not reportedNot reportedNot reportedNot reported
Phase I Cisplatin-pemetrexed Cediranib 20mg1Not reportedNot reportedNot reportedNot reported
Lymphocyte count decreased
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase I Cisplatin-pemetrexed Cediranib 30mg2Not reportedNot reportedNot reportedNot reported
Phase I Cisplatin-pemetrexed Cediranib 20mg0Not reportedNot reportedNot reportedNot reported
Mucositis oral
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase I Cisplatin-pemetrexed Cediranib 30mg0Not reportedNot reportedNot reportedNot reported
Phase I Cisplatin-pemetrexed Cediranib 20mg1Not reportedNot reportedNot reportedNot reported
Nausea
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase I Cisplatin-pemetrexed Cediranib 30mg0Not reportedNot reportedNot reportedNot reported
Phase I Cisplatin-pemetrexed Cediranib 20mg1Not reportedNot reportedNot reportedNot reported
Nervous system disorders - Other, specify
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase I Cisplatin-pemetrexed Cediranib 30mg0Not reportedNot reportedNot reportedNot reported
Phase I Cisplatin-pemetrexed Cediranib 20mg1Not reportedNot reportedNot reportedNot reported
Neutrophil count decreased
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase I Cisplatin-pemetrexed Cediranib 30mg1Not reportedNot reportedNot reportedNot reported
Phase I Cisplatin-pemetrexed Cediranib 20mg2Not reportedNot reportedNot reportedNot reported
Palmar-plantar erythrodysesthesia syndrome
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase I Cisplatin-pemetrexed Cediranib 30mg1Not reportedNot reportedNot reportedNot reported
Phase I Cisplatin-pemetrexed Cediranib 20mg0Not reportedNot reportedNot reportedNot reported
Peripheral sensory neuropathy
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase I Cisplatin-pemetrexed Cediranib 30mg0Not reportedNot reportedNot reportedNot reported
Phase I Cisplatin-pemetrexed Cediranib 20mg1Not reportedNot reportedNot reportedNot reported
Platelet count decreased
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase I Cisplatin-pemetrexed Cediranib 30mg0Not reportedNot reportedNot reportedNot reported
Phase I Cisplatin-pemetrexed Cediranib 20mg3Not reportedNot reportedNot reportedNot reported
Pulmonary hypertension
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase I Cisplatin-pemetrexed Cediranib 30mg0Not reportedNot reportedNot reportedNot reported
Phase I Cisplatin-pemetrexed Cediranib 20mg1Not reportedNot reportedNot reportedNot reported
Vomiting
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase I Cisplatin-pemetrexed Cediranib 30mg0Not reportedNot reportedNot reportedNot reported
Phase I Cisplatin-pemetrexed Cediranib 20mg2Not reportedNot reportedNot reportedNot reported
Weight loss
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase I Cisplatin-pemetrexed Cediranib 30mg1Not reportedNot reportedNot reportedNot reported
Phase I Cisplatin-pemetrexed Cediranib 20mg0Not reportedNot reportedNot reportedNot reported
White blood cell decreased
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase I Cisplatin-pemetrexed Cediranib 30mg0Not reportedNot reportedNot reportedNot reported
Phase I Cisplatin-pemetrexed Cediranib 20mg1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        2
    title
    Abdominal pain
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
    title
    Anemia
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
    title
    Constipation
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        3
    title
    Dehydration
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        2
    title
    Diarrhea
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        2
    title
    Dyspnea
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        1
    title
    Fatigue
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
    title
    Gastrointestinal disorders - Other, specify
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
    title
    Heart failure
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
    title
    Hypertension
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
    title
    Hypokalemia
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
    title
    Hypomagnesemia
denoms
  1. counts
    1. group Id
      OG000
      value
      7
    2. group Id
      OG001
      value
      13
    units
    Participants
description
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only adverse events that are possibly, probably or definitely related to study drug are reported.
groups
  1. description
    Phase I Cisplatin-pemetrexed Cediranib 30mg
    id
    OG000
    title
    Phase I Cisplatin-pemetrexed Cediranib 30mg
  2. description
    Phase I Cisplatin-pemetrexed Cediranib 20mg
    id
    OG001
    title
    Phase I Cisplatin-pemetrexed Cediranib 20mg
param Type
NUMBER
population Description
Patients who received at least one dose of protocol treatment.
reporting Status
POSTED
time Frame
Toxicity assessment is repeated weekly during first cycle (1cycle = 21 days), then every cycle while patient is on treatment.
title
(Phase I) Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice