NCT01077544 · ADVERSE EVENTS

Adverse events

A Pharmacokinetic (PK) Study of Nilotinib in Pediatric Patients With Philadelphia Chromosome-positive (Ph+) Chronic Myelogenous Leukemia (CML) or Acute Lymphoblastic Leukemia (ALL) · Source last updated 2020-12-29

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame: Not reported
Other-event reporting threshold: 5%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Group 1 1 year to \< 10 years pediatric patients	2 / 8	8 / 8	Not reported / Not reported
Group 2 \>= 10 years to \<18 years pediatric patients	3 / 7	7 / 7	Not reported / Not reported

Group identifiers: EG000: Group 1 · EG001: Group 2

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
0
num At Risk
8
group Id
EG001
num Affected
2
num At Risk
7
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
8
group Id
EG001
num Affected
0
num At Risk
7
term
Appendix disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
8
group Id
EG001
num Affected
0
num At Risk
7
term
Influenza like illness
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
8
group Id
EG001
num Affected
0
num At Risk
7
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
0
num At Risk
8
group Id
EG001
num Affected
1
num At Risk
7
term
Renal failure

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
0
num At Risk
8
group Id
EG001
num Affected
1
num At Risk
7
term
Haemolytic anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
0
num At Risk
8
group Id
EG001
num Affected
1
num At Risk
7
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
0
num At Risk
8
group Id
EG001
num Affected
1
num At Risk
7
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
0
num At Risk
8
group Id
EG001
num Affected
1
num At Risk
7
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
0
num At Risk
8
group Id
EG001
num Affected
1
num At Risk
7
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
0
num At Risk
8
group Id
EG001
num Affected
2
num At Risk
7
term
Ear pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
8
group Id
EG001
num Affected
2
num At Risk
7
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
8
group Id
EG001
num Affected
1
num At Risk
7
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
0
num At Risk
8
group Id
EG001
num Affected
1
num At Risk
7
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
8
group Id
EG001
num Affected
3
num At Risk
7
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
0
num At Risk
8
group Id
EG001
num Affected
3
num At Risk
7
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
8
group Id
EG001
num Affected
0
num At Risk
7
term
Odynophagia

Complete source fields

event Groups

description
1 year to \< 10 years pediatric patients
id
EG000
other Num Affected
8
other Num At Risk
8
serious Num Affected
2
serious Num At Risk
8
title
Group 1
description
\>= 10 years to \<18 years pediatric patients
id
EG001
other Num Affected
7
other Num At Risk
7
serious Num Affected
3
serious Num At Risk
7
title
Group 2

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
0
num At Risk
8
group Id
EG001
num Affected
1
num At Risk
7
term
Haemolytic anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
0
num At Risk
8
group Id
EG001
num Affected
1
num At Risk
7
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
0
num At Risk
8
group Id
EG001
num Affected
1
num At Risk
7
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
0
num At Risk
8
group Id
EG001
num Affected
1
num At Risk
7
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
0
num At Risk
8
group Id
EG001
num Affected
1
num At Risk
7
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
0
num At Risk
8
group Id
EG001
num Affected
2
num At Risk
7
term
Ear pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
8
group Id
EG001
num Affected
2
num At Risk
7
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
8
group Id
EG001
num Affected
1
num At Risk
7
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
0
num At Risk
8
group Id
EG001
num Affected
1
num At Risk
7
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
8
group Id
EG001
num Affected
3
num At Risk
7
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
0
num At Risk
8
group Id
EG001
num Affected
3
num At Risk
7
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
8
group Id
EG001
num Affected
0
num At Risk
7
term
Odynophagia

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
0
num At Risk
8
group Id
EG001
num Affected
2
num At Risk
7
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
8
group Id
EG001
num Affected
0
num At Risk
7
term
Appendix disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
8
group Id
EG001
num Affected
0
num At Risk
7
term
Influenza like illness
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
8
group Id
EG001
num Affected
0
num At Risk
7
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
0
num At Risk
8
group Id
EG001
num Affected
1
num At Risk
7
term
Renal failure

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice