NCT00481247 · OUTCOME

Number of Participants With Adverse Events (AEs), Drug-related AEs, Drug-related Serious Adverse Events (SAEs), Drug-related AEs Leading to Discontinuation, and All Deaths

A Phase III Study of Dasatinib vs Imatinib in Patients With Newly Diagnosed Chronic Phase Chronic Myeloid Leukemia · Source last updated 2017-02-15

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: From date of last person, first visit to date of last person, last visit (approximately 8 years)

What was measured

AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a subject administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.

Analysis population: All treated participants

Groups in this outcome

Dasatinib

Tablets, oral, dasatinib 100 mg once daily (QD)

Imatinib

Tablets, oral, imatinib 400 mg once daily (QD)

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
Dasatinib	258
Imatinib	258

Reported measurements

All AEs

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Dasatinib	251	Not reported	Not reported	Not reported	Not reported
Imatinib	251	Not reported	Not reported	Not reported	Not reported

All Drug-related AEs

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Dasatinib	224	Not reported	Not reported	Not reported	Not reported
Imatinib	231	Not reported	Not reported	Not reported	Not reported

Diarrhea

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Dasatinib	100	Not reported	Not reported	Not reported	Not reported
Imatinib	91	Not reported	Not reported	Not reported	Not reported

Pleural effusion

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Dasatinib	74	Not reported	Not reported	Not reported	Not reported
Imatinib	3	Not reported	Not reported	Not reported	Not reported

Nausea

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Dasatinib	40	Not reported	Not reported	Not reported	Not reported
Imatinib	74	Not reported	Not reported	Not reported	Not reported

Cough

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Dasatinib	68	Not reported	Not reported	Not reported	Not reported
Imatinib	28	Not reported	Not reported	Not reported	Not reported

Muscle spasms

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Dasatinib	14	Not reported	Not reported	Not reported	Not reported
Imatinib	63	Not reported	Not reported	Not reported	Not reported

Thrombocytopenia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Dasatinib	61	Not reported	Not reported	Not reported	Not reported
Imatinib	50	Not reported	Not reported	Not reported	Not reported

Neutropenia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Dasatinib	60	Not reported	Not reported	Not reported	Not reported
Imatinib	49	Not reported	Not reported	Not reported	Not reported

Headache

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Dasatinib	59	Not reported	Not reported	Not reported	Not reported
Imatinib	46	Not reported	Not reported	Not reported	Not reported

Pyrexia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Dasatinib	58	Not reported	Not reported	Not reported	Not reported
Imatinib	51	Not reported	Not reported	Not reported	Not reported

Vomiting

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Dasatinib	43	Not reported	Not reported	Not reported	Not reported
Imatinib	54	Not reported	Not reported	Not reported	Not reported

SAEs

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Dasatinib	90	Not reported	Not reported	Not reported	Not reported
Imatinib	70	Not reported	Not reported	Not reported	Not reported

Drug-related SAEs

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Dasatinib	43	Not reported	Not reported	Not reported	Not reported
Imatinib	22	Not reported	Not reported	Not reported	Not reported

AEs leading to discontinuation

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Dasatinib	51	Not reported	Not reported	Not reported	Not reported
Imatinib	26	Not reported	Not reported	Not reported	Not reported

All deaths

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Dasatinib	26	Not reported	Not reported	Not reported	Not reported
Imatinib	26	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
251
group Id
OG001
value
251
title
All AEs
categories
measurements
group Id
OG000
value
224
group Id
OG001
value
231
title
All Drug-related AEs
categories
measurements
group Id
OG000
value
100
group Id
OG001
value
91
title
Diarrhea
categories
measurements
group Id
OG000
value
74
group Id
OG001
value
3
title
Pleural effusion
categories
measurements
group Id
OG000
value
40
group Id
OG001
value
74
title
Nausea
categories
measurements
group Id
OG000
value
68
group Id
OG001
value
28
title
Cough
categories
measurements
group Id
OG000
value
14
group Id
OG001
value
63
title
Muscle spasms
categories
measurements
group Id
OG000
value
61
group Id
OG001
value
50
title
Thrombocytopenia
categories
measurements
group Id
OG000
value
60
group Id
OG001
value
49
title
Neutropenia
categories
measurements
group Id
OG000
value
59
group Id
OG001
value
46
title
Headache
categories
measurements
group Id
OG000
value
58
group Id
OG001
value
51
title
Pyrexia
categories
measurements
group Id
OG000
value
43
group Id
OG001
value
54
title
Vomiting

denoms

counts
group Id
OG000
value
258
group Id
OG001
value
258
units
Participants

description

groups

description
Tablets, oral, dasatinib 100 mg once daily (QD)
id
OG000
title
Dasatinib
description
Tablets, oral, imatinib 400 mg once daily (QD)
id
OG001
title
Imatinib

param Type

NUMBER

population Description

All treated participants

reporting Status

POSTED

time Frame

From date of last person, first visit to date of last person, last visit (approximately 8 years)

title

Number of Participants With Adverse Events (AEs), Drug-related AEs, Drug-related Serious Adverse Events (SAEs), Drug-related AEs Leading to Discontinuation, and All Deaths

type

OTHER_PRE_SPECIFIED

unit Of Measure

Participants

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Preserved source evidence · Not medical advice