NCT02668653 · OUTCOME

Number of Participants With Treatment-emergent Adverse Events Occurring in ≥10% Participants With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia

Quizartinib With Standard of Care Chemotherapy and as Continuation Therapy in Patients With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia (AML) · Source last updated 2024-08-06

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: Date of first dose up to 30 days after last dose, up to 36 cycles following continuation (approximately 6 years 11 months, each cycle is 28 days)

What was measured

A treatment-emergent adverse event (TEAE) is defined as an adverse event that occur, having been absent before first dose of quizartinib or placebo, or have worsened in severity after initiating quizartinib or placebo. Adverse events collected more than 30 days after the last dose of quizartinib/placebo will not be considered TEAEs unless they are considered drug-related.

Analysis population: Treatment-emergent adverse events were assessed in the Safety Analysis Set.

Groups in this outcome

Quizartinib

Participants who were randomized to receive quizartinib treatment regimen.

Placebo

Participants who were randomized to receive placebo treatment regimen.

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
Quizartinib	265
Placebo	268

Reported measurements

Any TEAE

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Quizartinib	264	Not reported	Not reported	Not reported	Not reported
Placebo	265	Not reported	Not reported	Not reported	Not reported

Gastrointestinal disorders

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Quizartinib	215	Not reported	Not reported	Not reported	Not reported
Placebo	209	Not reported	Not reported	Not reported	Not reported

Diarrhoea

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Quizartinib	98	Not reported	Not reported	Not reported	Not reported
Placebo	94	Not reported	Not reported	Not reported	Not reported

Nausea

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Quizartinib	90	Not reported	Not reported	Not reported	Not reported
Placebo	84	Not reported	Not reported	Not reported	Not reported

Vomiting

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Quizartinib	65	Not reported	Not reported	Not reported	Not reported
Placebo	53	Not reported	Not reported	Not reported	Not reported

Stomatitis

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Quizartinib	57	Not reported	Not reported	Not reported	Not reported
Placebo	56	Not reported	Not reported	Not reported	Not reported

Constipation

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Quizartinib	56	Not reported	Not reported	Not reported	Not reported
Placebo	69	Not reported	Not reported	Not reported	Not reported

Abdominal pain

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Quizartinib	46	Not reported	Not reported	Not reported	Not reported
Placebo	38	Not reported	Not reported	Not reported	Not reported

Dyspepsia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Quizartinib	30	Not reported	Not reported	Not reported	Not reported
Placebo	23	Not reported	Not reported	Not reported	Not reported

Abdominal pain upper

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Quizartinib	29	Not reported	Not reported	Not reported	Not reported
Placebo	25	Not reported	Not reported	Not reported	Not reported

Infections and infestations

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Quizartinib	204	Not reported	Not reported	Not reported	Not reported
Placebo	188	Not reported	Not reported	Not reported	Not reported

Pneumonia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Quizartinib	39	Not reported	Not reported	Not reported	Not reported
Placebo	41	Not reported	Not reported	Not reported	Not reported

Sepsis

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Quizartinib	15	Not reported	Not reported	Not reported	Not reported
Placebo	28	Not reported	Not reported	Not reported	Not reported

General disorders and administration site disorders

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Quizartinib	177	Not reported	Not reported	Not reported	Not reported
Placebo	173	Not reported	Not reported	Not reported	Not reported

Pyrexia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Quizartinib	112	Not reported	Not reported	Not reported	Not reported
Placebo	109	Not reported	Not reported	Not reported	Not reported

Oedema peripheral

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Quizartinib	30	Not reported	Not reported	Not reported	Not reported
Placebo	37	Not reported	Not reported	Not reported	Not reported

Fatigue

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Quizartinib	29	Not reported	Not reported	Not reported	Not reported
Placebo	23	Not reported	Not reported	Not reported	Not reported

Blood and lymphatic system disorders

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Quizartinib	168	Not reported	Not reported	Not reported	Not reported
Placebo	143	Not reported	Not reported	Not reported	Not reported

Febrile neutropenia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Quizartinib	117	Not reported	Not reported	Not reported	Not reported
Placebo	113	Not reported	Not reported	Not reported	Not reported

Neutropenia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Quizartinib	54	Not reported	Not reported	Not reported	Not reported
Placebo	27	Not reported	Not reported	Not reported	Not reported

Thrombocytopenia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Quizartinib	30	Not reported	Not reported	Not reported	Not reported
Placebo	30	Not reported	Not reported	Not reported	Not reported

Anaemia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Quizartinib	29	Not reported	Not reported	Not reported	Not reported
Placebo	19	Not reported	Not reported	Not reported	Not reported

Metabolism and nutrition disorders

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Quizartinib	165	Not reported	Not reported	Not reported	Not reported
Placebo	153	Not reported	Not reported	Not reported	Not reported

Hypokalaemia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Quizartinib	93	Not reported	Not reported	Not reported	Not reported
Placebo	96	Not reported	Not reported	Not reported	Not reported

Decreased appetite

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Quizartinib	46	Not reported	Not reported	Not reported	Not reported
Placebo	36	Not reported	Not reported	Not reported	Not reported

Hypomagnesaemia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Quizartinib	30	Not reported	Not reported	Not reported	Not reported
Placebo	30	Not reported	Not reported	Not reported	Not reported

Hypophosphataemia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Quizartinib	27	Not reported	Not reported	Not reported	Not reported
Placebo	24	Not reported	Not reported	Not reported	Not reported

Hypocalcaemia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Quizartinib	26	Not reported	Not reported	Not reported	Not reported
Placebo	29	Not reported	Not reported	Not reported	Not reported

Skin and subcutaneous tissue disorders

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Quizartinib	152	Not reported	Not reported	Not reported	Not reported
Placebo	158	Not reported	Not reported	Not reported	Not reported

Rash

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Quizartinib	69	Not reported	Not reported	Not reported	Not reported
Placebo	66	Not reported	Not reported	Not reported	Not reported

Pruritus

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Quizartinib	35	Not reported	Not reported	Not reported	Not reported
Placebo	40	Not reported	Not reported	Not reported	Not reported

Investigations

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Quizartinib	140	Not reported	Not reported	Not reported	Not reported
Placebo	105	Not reported	Not reported	Not reported	Not reported

Alanine aminotransferase increased

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Quizartinib	42	Not reported	Not reported	Not reported	Not reported
Placebo	27	Not reported	Not reported	Not reported	Not reported

Electrocardiogram QT prolonged

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Quizartinib	36	Not reported	Not reported	Not reported	Not reported
Placebo	11	Not reported	Not reported	Not reported	Not reported

Aspartate aminotransferase increased

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Quizartinib	28	Not reported	Not reported	Not reported	Not reported
Placebo	19	Not reported	Not reported	Not reported	Not reported

Neutrophil count decreased

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Quizartinib	27	Not reported	Not reported	Not reported	Not reported
Placebo	12	Not reported	Not reported	Not reported	Not reported

Respiratory, thoracic, and mediastinal disorders

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Quizartinib	123	Not reported	Not reported	Not reported	Not reported
Placebo	115	Not reported	Not reported	Not reported	Not reported

Cough

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Quizartinib	50	Not reported	Not reported	Not reported	Not reported
Placebo	44	Not reported	Not reported	Not reported	Not reported

Epistaxis

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Quizartinib	40	Not reported	Not reported	Not reported	Not reported
Placebo	29	Not reported	Not reported	Not reported	Not reported

Oropharyngeal pain

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Quizartinib	27	Not reported	Not reported	Not reported	Not reported
Placebo	18	Not reported	Not reported	Not reported	Not reported

Nervous system disorders

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Quizartinib	103	Not reported	Not reported	Not reported	Not reported
Placebo	97	Not reported	Not reported	Not reported	Not reported

Headache

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Quizartinib	73	Not reported	Not reported	Not reported	Not reported
Placebo	53	Not reported	Not reported	Not reported	Not reported

Musculoskeletal and connective tissue disorders

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Quizartinib	91	Not reported	Not reported	Not reported	Not reported
Placebo	108	Not reported	Not reported	Not reported	Not reported

Arthralgia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Quizartinib	29	Not reported	Not reported	Not reported	Not reported
Placebo	35	Not reported	Not reported	Not reported	Not reported

Back pain

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Quizartinib	19	Not reported	Not reported	Not reported	Not reported
Placebo	28	Not reported	Not reported	Not reported	Not reported

Vascular disorders

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Quizartinib	71	Not reported	Not reported	Not reported	Not reported
Placebo	70	Not reported	Not reported	Not reported	Not reported

Hypertension

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Quizartinib	29	Not reported	Not reported	Not reported	Not reported
Placebo	33	Not reported	Not reported	Not reported	Not reported

Psychiatric disorders

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Quizartinib	57	Not reported	Not reported	Not reported	Not reported
Placebo	50	Not reported	Not reported	Not reported	Not reported

Insomnia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Quizartinib	37	Not reported	Not reported	Not reported	Not reported
Placebo	30	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
264
group Id
OG001
value
265
title
Any TEAE
categories
measurements
group Id
OG000
value
215
group Id
OG001
value
209
title
Gastrointestinal disorders
categories
measurements
group Id
OG000
value
98
group Id
OG001
value
94
title
Diarrhoea
categories
measurements
group Id
OG000
value
90
group Id
OG001
value
84
title
Nausea
categories
measurements
group Id
OG000
value
65
group Id
OG001
value
53
title
Vomiting
categories
measurements
group Id
OG000
value
57
group Id
OG001
value
56
title
Stomatitis
categories
measurements
group Id
OG000
value
56
group Id
OG001
value
69
title
Constipation
categories
measurements
group Id
OG000
value
46
group Id
OG001
value
38
title
Abdominal pain
categories
measurements
group Id
OG000
value
30
group Id
OG001
value
23
title
Dyspepsia
categories
measurements
group Id
OG000
value
29
group Id
OG001
value
25
title
Abdominal pain upper
categories
measurements
group Id
OG000
value
204
group Id
OG001
value
188
title
Infections and infestations
categories
measurements
group Id
OG000
value
39
group Id
OG001
value
41
title
Pneumonia

denoms

counts
group Id
OG000
value
265
group Id
OG001
value
268
units
Participants

description

groups

description
Participants who were randomized to receive quizartinib treatment regimen.
id
OG000
title
Quizartinib
description
Participants who were randomized to receive placebo treatment regimen.
id
OG001
title
Placebo

param Type

COUNT_OF_PARTICIPANTS

population Description

Treatment-emergent adverse events were assessed in the Safety Analysis Set.

reporting Status

POSTED

time Frame

Date of first dose up to 30 days after last dose, up to 36 cycles following continuation (approximately 6 years 11 months, each cycle is 28 days)

title

Number of Participants With Treatment-emergent Adverse Events Occurring in ≥10% Participants With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia

type

SECONDARY

unit Of Measure

Participants

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Preserved source evidence · Not medical advice