NCT00866281 · ADVERSE EVENTS

Adverse events

A Study of the Safety and Preliminary Efficacy of Oral Midostaurin (PKC412) in Relapsed or Refractory Pediatric Leukemia · Source last updated 2015-12-22

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: Serious Adverse Events are monitored from date of First Participant First Visit (FPFV) up to Last Participant Last Visit (LPLV), 24 weeks and all other adverse events are monitored from First Participant First Treatment (FPFT) up to LPLV, 20 weeks
Other-event reporting threshold: 5%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Cohort 1: Midostaurin (30 Milligrams/Meters^2) Participants received bodyweight and BSA stratified dose of midostaurin 30 mg/m\^2 bid through oral route. The total daily dose in 30 mg/m\^2 bid cohort was 60 mg/m\^2.	3 / 7	6 / 7	Not reported / Not reported
Cohort 2: Midostaurin (60 mg/m^2) Participants received bodyweight and BSA stratified dose of midostaurin 60 mg/m\^2 bid through oral route. The total daily dose in 60 mg/m\^2 bid cohort was 120 mg/m\^2.	6 / 15	15 / 15	Not reported / Not reported

Group identifiers: EG000: Cohort 1: Midostaurin (30 Milligrams/Meters^2) · EG001: Cohort 2: Midostaurin (60 mg/m^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
17.0
stats
group Id
EG000
num Affected
1
num At Risk
7
group Id
EG001
num Affected
1
num At Risk
15
term
Febrile Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
17.0
stats
group Id
EG000
num Affected
1
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
15
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
17.0
stats
group Id
EG000
num Affected
1
num At Risk
7
group Id
EG001
num Affected
1
num At Risk
15
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
17.0
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
1
num At Risk
15
term
Tongue Oedema
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
17.0
stats
group Id
EG000
num Affected
1
num At Risk
7
group Id
EG001
num Affected
1
num At Risk
15
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
17.0
stats
group Id
EG000
num Affected
1
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
15
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
17.0
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
1
num At Risk
15
term
Cytokine Release Syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
17.0
stats
group Id
EG000
num Affected
1
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
15
term
Infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
17.0
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
1
num At Risk
15
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
17.0
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
1
num At Risk
15
term
Tongue Injury
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
17.0
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
1
num At Risk
15
term
Alanine Aminotransferase Increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
17.0
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
1
num At Risk
15
term
Blast Cell Count Increased

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
17.0
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
5
num At Risk
15
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
17.0
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
1
num At Risk
15
term
Febrile Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
17.0
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
1
num At Risk
15
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
17.0
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
2
num At Risk
15
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
17.0
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
3
num At Risk
15
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
17.0
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
9
num At Risk
15
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
17.0
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
1
num At Risk
15
term
Sinus Tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
17.0
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
1
num At Risk
15
term
Tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
17.0
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
1
num At Risk
15
term
Abdominal Distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
17.0
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
1
num At Risk
15
term
Abdominal Pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
17.0
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
1
num At Risk
15
term
Abdominal Pain Upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
17.0
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
1
num At Risk
15
term
Constipation

Complete source fields

event Groups

description
Participants received bodyweight and BSA stratified dose of midostaurin 30 mg/m\^2 bid through oral route. The total daily dose in 30 mg/m\^2 bid cohort was 60 mg/m\^2.
id
EG000
other Num Affected
6
other Num At Risk
7
serious Num Affected
3
serious Num At Risk
7
title
Cohort 1: Midostaurin (30 Milligrams/Meters^2)
description
Participants received bodyweight and BSA stratified dose of midostaurin 60 mg/m\^2 bid through oral route. The total daily dose in 60 mg/m\^2 bid cohort was 120 mg/m\^2.
id
EG001
other Num Affected
15
other Num At Risk
15
serious Num Affected
6
serious Num At Risk
15
title
Cohort 2: Midostaurin (60 mg/m^2)

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
17.0
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
5
num At Risk
15
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
17.0
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
1
num At Risk
15
term
Febrile Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
17.0
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
1
num At Risk
15
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
17.0
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
2
num At Risk
15
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
17.0
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
3
num At Risk
15
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
17.0
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
9
num At Risk
15
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
17.0
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
1
num At Risk
15
term
Sinus Tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
17.0
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
1
num At Risk
15
term
Tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
17.0
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
1
num At Risk
15
term
Abdominal Distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
17.0
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
1
num At Risk
15
term
Abdominal Pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
17.0
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
1
num At Risk
15
term
Abdominal Pain Upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
17.0
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
1
num At Risk
15
term
Constipation

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
17.0
stats
group Id
EG000
num Affected
1
num At Risk
7
group Id
EG001
num Affected
1
num At Risk
15
term
Febrile Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
17.0
stats
group Id
EG000
num Affected
1
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
15
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
17.0
stats
group Id
EG000
num Affected
1
num At Risk
7
group Id
EG001
num Affected
1
num At Risk
15
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
17.0
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
1
num At Risk
15
term
Tongue Oedema
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
17.0
stats
group Id
EG000
num Affected
1
num At Risk
7
group Id
EG001
num Affected
1
num At Risk
15
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
17.0
stats
group Id
EG000
num Affected
1
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
15
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
17.0
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
1
num At Risk
15
term
Cytokine Release Syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
17.0
stats
group Id
EG000
num Affected
1
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
15
term
Infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
17.0
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
1
num At Risk
15
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
17.0
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
1
num At Risk
15
term
Tongue Injury
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
17.0
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
1
num At Risk
15
term
Alanine Aminotransferase Increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
17.0
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
1
num At Risk
15
term
Blast Cell Count Increased

time Frame

Serious Adverse Events are monitored from date of First Participant First Visit (FPFV) up to Last Participant Last Visit (LPLV), 24 weeks and all other adverse events are monitored from First Participant First Treatment (FPFT) up to LPLV, 20 weeks

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Preserved source evidence · Not medical advice