NCT01064648 · OUTCOME

(Phase II) 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 every 3 weeks 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 II Cisplatin-pemetrexed Cediranib 20mg

Phase II Cisplatin-pemetrexed Placebo

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

Analysis denominator · Participants

Group	Source count
Phase II Cisplatin-pemetrexed Cediranib 20mg	44
Phase II Cisplatin-pemetrexed Placebo	44

Reported measurements

Acute coronary syndrome

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase II Cisplatin-pemetrexed Cediranib 20mg	0	Not reported	Not reported	Not reported	Not reported
Phase II Cisplatin-pemetrexed Placebo	1	Not reported	Not reported	Not reported	Not reported

Anemia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase II Cisplatin-pemetrexed Cediranib 20mg	1	Not reported	Not reported	Not reported	Not reported
Phase II Cisplatin-pemetrexed Placebo	7	Not reported	Not reported	Not reported	Not reported

Anorexia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase II Cisplatin-pemetrexed Cediranib 20mg	7	Not reported	Not reported	Not reported	Not reported
Phase II Cisplatin-pemetrexed Placebo	4	Not reported	Not reported	Not reported	Not reported

Atrial fibrillation

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase II Cisplatin-pemetrexed Cediranib 20mg	2	Not reported	Not reported	Not reported	Not reported
Phase II Cisplatin-pemetrexed Placebo	0	Not reported	Not reported	Not reported	Not reported

Atrial flutter

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase II Cisplatin-pemetrexed Cediranib 20mg	1	Not reported	Not reported	Not reported	Not reported
Phase II Cisplatin-pemetrexed Placebo	1	Not reported	Not reported	Not reported	Not reported

Chest wall pain

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase II Cisplatin-pemetrexed Cediranib 20mg	0	Not reported	Not reported	Not reported	Not reported
Phase II Cisplatin-pemetrexed Placebo	1	Not reported	Not reported	Not reported	Not reported

Creatinine increased

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase II Cisplatin-pemetrexed Cediranib 20mg	0	Not reported	Not reported	Not reported	Not reported
Phase II Cisplatin-pemetrexed Placebo	1	Not reported	Not reported	Not reported	Not reported

Death NOS

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase II Cisplatin-pemetrexed Cediranib 20mg	1	Not reported	Not reported	Not reported	Not reported
Phase II Cisplatin-pemetrexed Placebo	0	Not reported	Not reported	Not reported	Not reported

Dehydration

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase II Cisplatin-pemetrexed Cediranib 20mg	4	Not reported	Not reported	Not reported	Not reported
Phase II Cisplatin-pemetrexed Placebo	2	Not reported	Not reported	Not reported	Not reported

Delirium

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase II Cisplatin-pemetrexed Cediranib 20mg	0	Not reported	Not reported	Not reported	Not reported
Phase II Cisplatin-pemetrexed Placebo	1	Not reported	Not reported	Not reported	Not reported

Diarrhea

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase II Cisplatin-pemetrexed Cediranib 20mg	2	Not reported	Not reported	Not reported	Not reported
Phase II Cisplatin-pemetrexed Placebo	0	Not reported	Not reported	Not reported	Not reported

Duodenal hemorrhage

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase II Cisplatin-pemetrexed Cediranib 20mg	0	Not reported	Not reported	Not reported	Not reported
Phase II Cisplatin-pemetrexed Placebo	1	Not reported	Not reported	Not reported	Not reported

Dyspnea

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase II Cisplatin-pemetrexed Cediranib 20mg	2	Not reported	Not reported	Not reported	Not reported
Phase II Cisplatin-pemetrexed Placebo	2	Not reported	Not reported	Not reported	Not reported

Epistaxis

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase II Cisplatin-pemetrexed Cediranib 20mg	1	Not reported	Not reported	Not reported	Not reported
Phase II Cisplatin-pemetrexed Placebo	0	Not reported	Not reported	Not reported	Not reported

Fall

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase II Cisplatin-pemetrexed Cediranib 20mg	1	Not reported	Not reported	Not reported	Not reported
Phase II Cisplatin-pemetrexed Placebo	0	Not reported	Not reported	Not reported	Not reported

Fatigue

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase II Cisplatin-pemetrexed Cediranib 20mg	6	Not reported	Not reported	Not reported	Not reported
Phase II Cisplatin-pemetrexed Placebo	5	Not reported	Not reported	Not reported	Not reported

General disorders and admin site conditions-Other

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase II Cisplatin-pemetrexed Cediranib 20mg	0	Not reported	Not reported	Not reported	Not reported
Phase II Cisplatin-pemetrexed Placebo	1	Not reported	Not reported	Not reported	Not reported

Generalized muscle weakness

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase II Cisplatin-pemetrexed Cediranib 20mg	1	Not reported	Not reported	Not reported	Not reported
Phase II Cisplatin-pemetrexed Placebo	1	Not reported	Not reported	Not reported	Not reported

Glucose intolerance

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase II Cisplatin-pemetrexed Cediranib 20mg	1	Not reported	Not reported	Not reported	Not reported
Phase II Cisplatin-pemetrexed Placebo	0	Not reported	Not reported	Not reported	Not reported

Headache

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase II Cisplatin-pemetrexed Cediranib 20mg	1	Not reported	Not reported	Not reported	Not reported
Phase II Cisplatin-pemetrexed Placebo	0	Not reported	Not reported	Not reported	Not reported

Hearing impaired

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase II Cisplatin-pemetrexed Cediranib 20mg	0	Not reported	Not reported	Not reported	Not reported
Phase II Cisplatin-pemetrexed Placebo	2	Not reported	Not reported	Not reported	Not reported

Heart failure

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase II Cisplatin-pemetrexed Cediranib 20mg	1	Not reported	Not reported	Not reported	Not reported
Phase II Cisplatin-pemetrexed Placebo	0	Not reported	Not reported	Not reported	Not reported

Hyperglycemia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase II Cisplatin-pemetrexed Cediranib 20mg	1	Not reported	Not reported	Not reported	Not reported
Phase II Cisplatin-pemetrexed Placebo	0	Not reported	Not reported	Not reported	Not reported

Hypertension

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase II Cisplatin-pemetrexed Cediranib 20mg	9	Not reported	Not reported	Not reported	Not reported
Phase II Cisplatin-pemetrexed Placebo	0	Not reported	Not reported	Not reported	Not reported

Hypocalcemia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase II Cisplatin-pemetrexed Cediranib 20mg	1	Not reported	Not reported	Not reported	Not reported
Phase II Cisplatin-pemetrexed Placebo	1	Not reported	Not reported	Not reported	Not reported

Hypokalemia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase II Cisplatin-pemetrexed Cediranib 20mg	2	Not reported	Not reported	Not reported	Not reported
Phase II Cisplatin-pemetrexed Placebo	0	Not reported	Not reported	Not reported	Not reported

Hypomagnesemia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase II Cisplatin-pemetrexed Cediranib 20mg	2	Not reported	Not reported	Not reported	Not reported
Phase II Cisplatin-pemetrexed Placebo	0	Not reported	Not reported	Not reported	Not reported

Hyponatremia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase II Cisplatin-pemetrexed Cediranib 20mg	5	Not reported	Not reported	Not reported	Not reported
Phase II Cisplatin-pemetrexed Placebo	1	Not reported	Not reported	Not reported	Not reported

Hypotension

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase II Cisplatin-pemetrexed Cediranib 20mg	3	Not reported	Not reported	Not reported	Not reported
Phase II Cisplatin-pemetrexed Placebo	0	Not reported	Not reported	Not reported	Not reported

Hypoxia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase II Cisplatin-pemetrexed Cediranib 20mg	0	Not reported	Not reported	Not reported	Not reported
Phase II Cisplatin-pemetrexed Placebo	1	Not reported	Not reported	Not reported	Not reported

Intracranial hemorrhage

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase II Cisplatin-pemetrexed Cediranib 20mg	1	Not reported	Not reported	Not reported	Not reported
Phase II Cisplatin-pemetrexed Placebo	0	Not reported	Not reported	Not reported	Not reported

Lung infection

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase II Cisplatin-pemetrexed Cediranib 20mg	1	Not reported	Not reported	Not reported	Not reported
Phase II Cisplatin-pemetrexed Placebo	1	Not reported	Not reported	Not reported	Not reported

Lymphocyte count decreased

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase II Cisplatin-pemetrexed Cediranib 20mg	2	Not reported	Not reported	Not reported	Not reported
Phase II Cisplatin-pemetrexed Placebo	2	Not reported	Not reported	Not reported	Not reported

Mucositis oral

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase II Cisplatin-pemetrexed Cediranib 20mg	1	Not reported	Not reported	Not reported	Not reported
Phase II Cisplatin-pemetrexed Placebo	0	Not reported	Not reported	Not reported	Not reported

Nausea

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase II Cisplatin-pemetrexed Cediranib 20mg	4	Not reported	Not reported	Not reported	Not reported
Phase II Cisplatin-pemetrexed Placebo	5	Not reported	Not reported	Not reported	Not reported

Neutrophil count decreased

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase II Cisplatin-pemetrexed Cediranib 20mg	6	Not reported	Not reported	Not reported	Not reported
Phase II Cisplatin-pemetrexed Placebo	8	Not reported	Not reported	Not reported	Not reported

Non-cardiac chest pain

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase II Cisplatin-pemetrexed Cediranib 20mg	1	Not reported	Not reported	Not reported	Not reported
Phase II Cisplatin-pemetrexed Placebo	0	Not reported	Not reported	Not reported	Not reported

Peripheral sensory neuropathy

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase II Cisplatin-pemetrexed Cediranib 20mg	0	Not reported	Not reported	Not reported	Not reported
Phase II Cisplatin-pemetrexed Placebo	1	Not reported	Not reported	Not reported	Not reported

Platelet count decreased

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase II Cisplatin-pemetrexed Cediranib 20mg	4	Not reported	Not reported	Not reported	Not reported
Phase II Cisplatin-pemetrexed Placebo	2	Not reported	Not reported	Not reported	Not reported

Rash maculo-papular

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase II Cisplatin-pemetrexed Cediranib 20mg	1	Not reported	Not reported	Not reported	Not reported
Phase II Cisplatin-pemetrexed Placebo	0	Not reported	Not reported	Not reported	Not reported

Renal and urinary disorders - Other, specify

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase II Cisplatin-pemetrexed Cediranib 20mg	0	Not reported	Not reported	Not reported	Not reported
Phase II Cisplatin-pemetrexed Placebo	1	Not reported	Not reported	Not reported	Not reported

Respiratory failure

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase II Cisplatin-pemetrexed Cediranib 20mg	2	Not reported	Not reported	Not reported	Not reported
Phase II Cisplatin-pemetrexed Placebo	0	Not reported	Not reported	Not reported	Not reported

Seizure

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase II Cisplatin-pemetrexed Cediranib 20mg	1	Not reported	Not reported	Not reported	Not reported
Phase II Cisplatin-pemetrexed Placebo	0	Not reported	Not reported	Not reported	Not reported

Sinus bradycardia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase II Cisplatin-pemetrexed Cediranib 20mg	2	Not reported	Not reported	Not reported	Not reported
Phase II Cisplatin-pemetrexed Placebo	0	Not reported	Not reported	Not reported	Not reported

Supraventricular tachycardia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase II Cisplatin-pemetrexed Cediranib 20mg	1	Not reported	Not reported	Not reported	Not reported
Phase II Cisplatin-pemetrexed Placebo	0	Not reported	Not reported	Not reported	Not reported

Syncope

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase II Cisplatin-pemetrexed Cediranib 20mg	0	Not reported	Not reported	Not reported	Not reported
Phase II Cisplatin-pemetrexed Placebo	1	Not reported	Not reported	Not reported	Not reported

Thromboembolic event

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase II Cisplatin-pemetrexed Cediranib 20mg	3	Not reported	Not reported	Not reported	Not reported
Phase II Cisplatin-pemetrexed Placebo	3	Not reported	Not reported	Not reported	Not reported

Urinary tract infection

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase II Cisplatin-pemetrexed Cediranib 20mg	0	Not reported	Not reported	Not reported	Not reported
Phase II Cisplatin-pemetrexed Placebo	1	Not reported	Not reported	Not reported	Not reported

Vomiting

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase II Cisplatin-pemetrexed Cediranib 20mg	0	Not reported	Not reported	Not reported	Not reported
Phase II Cisplatin-pemetrexed Placebo	2	Not reported	Not reported	Not reported	Not reported

Weight loss

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase II Cisplatin-pemetrexed Cediranib 20mg	4	Not reported	Not reported	Not reported	Not reported
Phase II Cisplatin-pemetrexed Placebo	0	Not reported	Not reported	Not reported	Not reported

White blood cell decreased

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase II Cisplatin-pemetrexed Cediranib 20mg	3	Not reported	Not reported	Not reported	Not reported
Phase II Cisplatin-pemetrexed Placebo	4	Not reported	Not reported	Not reported	Not reported

Wound dehiscence

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase II Cisplatin-pemetrexed Cediranib 20mg	1	Not reported	Not reported	Not reported	Not reported
Phase II Cisplatin-pemetrexed Placebo	0	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
0
group Id
OG001
value
1
title
Acute coronary syndrome
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
7
title
Anemia
categories
measurements
group Id
OG000
value
7
group Id
OG001
value
4
title
Anorexia
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
0
title
Atrial fibrillation
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
1
title
Atrial flutter
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
1
title
Chest wall pain
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
1
title
Creatinine increased
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
0
title
Death NOS
categories
measurements
group Id
OG000
value
4
group Id
OG001
value
2
title
Dehydration
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
1
title
Delirium
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
0
title
Diarrhea
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
1
title
Duodenal hemorrhage

denoms

counts
group Id
OG000
value
44
group Id
OG001
value
44
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

description
Phase II Cisplatin-pemetrexed Cediranib 20mg
id
OG000
title
Phase II Cisplatin-pemetrexed Cediranib 20mg
description
Phase II Cisplatin-pemetrexed Placebo
id
OG001
title
Phase II Cisplatin-pemetrexed Placebo

param Type

NUMBER

population Description

Patients who received at least one dose of protocol treatment.

reporting Status

POSTED

time Frame

Toxicity assessment is repeated every 3 weeks while patient is on treatment.

title

(Phase II) 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