Number of Patients Cycles With Grade 3 or Higher Adverse Event
Alisertib in Treating Young Patients With Recurrent or Refractory Solid Tumors or Leukemia · Source last updated 2020-05-13
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
Measure
NUMBER
Unit
Patient-cycle
Interval / dispersion
Not reported
Time frame
Up to 24 months
What was measured
The number of patient-cycles in which the adverse event considered grade 3 or higher AE according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 considered by the treating physician to be possibly, probably or definitely related to alisertib.
Analysis population: 116 patients contributed 360 patient-cycles to the analysis.
Groups in this outcome
All Patients
All patients
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
All Patients
116
Reported measurements
Abdominal Pain
Values in Patient-cycle · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
All Patients
3
Not reported
Not reported
Not reported
Not reported
Prolonged Partial Thromboplatin Time
Values in Patient-cycle · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
All Patients
1
Not reported
Not reported
Not reported
Not reported
Acute Kidney Injury
Values in Patient-cycle · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
All Patients
1
Not reported
Not reported
Not reported
Not reported
Agitation
Values in Patient-cycle · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
All Patients
1
Not reported
Not reported
Not reported
Not reported
Alanine Aminotransferase Elevation
Values in Patient-cycle · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
All Patients
25
Not reported
Not reported
Not reported
Not reported
Allergic Reaction
Values in Patient-cycle · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
All Patients
1
Not reported
Not reported
Not reported
Not reported
Alopecia
Values in Patient-cycle · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
All Patients
27
Not reported
Not reported
Not reported
Not reported
Anal Mucocitis
Values in Patient-cycle · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
All Patients
1
Not reported
Not reported
Not reported
Not reported
Anemia
Values in Patient-cycle · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
All Patients
141
Not reported
Not reported
Not reported
Not reported
Anorexia
Values in Patient-cycle · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
All Patients
8
Not reported
Not reported
Not reported
Not reported
Aspartate Aminotransferase Increase
Values in Patient-cycle · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
All Patients
15
Not reported
Not reported
Not reported
Not reported
Back Pain
Values in Patient-cycle · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
All Patients
1
Not reported
Not reported
Not reported
Not reported
Blood Bilirubin Increase
Values in Patient-cycle · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
All Patients
7
Not reported
Not reported
Not reported
Not reported
Blurred Vision
Values in Patient-cycle · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
All Patients
2
Not reported
Not reported
Not reported
Not reported
Bullous Dermatitis
Values in Patient-cycle · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
All Patients
1
Not reported
Not reported
Not reported
Not reported
Colitis
Values in Patient-cycle · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
All Patients
2
Not reported
Not reported
Not reported
Not reported
Confusion
Values in Patient-cycle · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
All Patients
1
Not reported
Not reported
Not reported
Not reported
Dehydration
Values in Patient-cycle · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
All Patients
5
Not reported
Not reported
Not reported
Not reported
Depression
Values in Patient-cycle · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
All Patients
1
Not reported
Not reported
Not reported
Not reported
Diarrhea
Values in Patient-cycle · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
All Patients
8
Not reported
Not reported
Not reported
Not reported
Dizziness
Values in Patient-cycle · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
All Patients
15
Not reported
Not reported
Not reported
Not reported
Dry Mouth
Values in Patient-cycle · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
All Patients
1
Not reported
Not reported
Not reported
Not reported
Enterocolitis
Values in Patient-cycle · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
All Patients
1
Not reported
Not reported
Not reported
Not reported
Erectile Dysfunction
Values in Patient-cycle · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
All Patients
1
Not reported
Not reported
Not reported
Not reported
Euphoria
Values in Patient-cycle · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
All Patients
3
Not reported
Not reported
Not reported
Not reported
Eye Pain
Values in Patient-cycle · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
All Patients
1
Not reported
Not reported
Not reported
Not reported
Fatigue
Values in Patient-cycle · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
All Patients
14
Not reported
Not reported
Not reported
Not reported
Febrile Neutropenia
Values in Patient-cycle · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
All Patients
13
Not reported
Not reported
Not reported
Not reported
Other Gastrointestinal Disorders
Values in Patient-cycle · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
All Patients
1
Not reported
Not reported
Not reported
Not reported
GGT Increase
Values in Patient-cycle · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
All Patients
2
Not reported
Not reported
Not reported
Not reported
Headache
Values in Patient-cycle · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
All Patients
3
Not reported
Not reported
Not reported
Not reported
Hepatic Hemhorrage
Values in Patient-cycle · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
All Patients
1
Not reported
Not reported
Not reported
Not reported
Hyperkalemia
Values in Patient-cycle · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
All Patients
1
Not reported
Not reported
Not reported
Not reported
Hypersomnia
Values in Patient-cycle · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
All Patients
1
Not reported
Not reported
Not reported
Not reported
Hyperuricemia
Values in Patient-cycle · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
All Patients
1
Not reported
Not reported
Not reported
Not reported
Hypoalbuminemia
Values in Patient-cycle · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
All Patients
7
Not reported
Not reported
Not reported
Not reported
Hypocalcemia
Values in Patient-cycle · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
All Patients
2
Not reported
Not reported
Not reported
Not reported
Hypokalemia
Values in Patient-cycle · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
All Patients
9
Not reported
Not reported
Not reported
Not reported
Hyponatremia
Values in Patient-cycle · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
All Patients
3
Not reported
Not reported
Not reported
Not reported
Hypophosphatemia
Values in Patient-cycle · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
All Patients
1
Not reported
Not reported
Not reported
Not reported
Other Infections
Values in Patient-cycle · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
All Patients
1
Not reported
Not reported
Not reported
Not reported
INR Increase
Values in Patient-cycle · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
All Patients
1
Not reported
Not reported
Not reported
Not reported
Keratitis
Values in Patient-cycle · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
All Patients
1
Not reported
Not reported
Not reported
Not reported
Lethargy
Values in Patient-cycle · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
All Patients
1
Not reported
Not reported
Not reported
Not reported
Lung Infection
Values in Patient-cycle · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
All Patients
1
Not reported
Not reported
Not reported
Not reported
Lymphocyte Count Decrease
Values in Patient-cycle · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
All Patients
65
Not reported
Not reported
Not reported
Not reported
Lymphocyte Count Increase
Values in Patient-cycle · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
All Patients
1
Not reported
Not reported
Not reported
Not reported
Mucosal Infection
Values in Patient-cycle · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
All Patients
2
Not reported
Not reported
Not reported
Not reported
Oral Mucocitis
Values in Patient-cycle · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
All Patients
35
Not reported
Not reported
Not reported
Not reported
Nausea
Values in Patient-cycle · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
All Patients
11
Not reported
Not reported
Not reported
Not reported
Decreased Neutrophil Count
Values in Patient-cycle · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
All Patients
208
Not reported
Not reported
Not reported
Not reported
Oral Pain
Values in Patient-cycle · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
All Patients
12
Not reported
Not reported
Not reported
Not reported
Otitis Media
Values in Patient-cycle · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
All Patients
1
Not reported
Not reported
Not reported
Not reported
Pain in an Extremity
Values in Patient-cycle · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
All Patients
1
Not reported
Not reported
Not reported
Not reported
Palmar-Plantar Erythrodysesthesia Syndrome
Values in Patient-cycle · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
All Patients
10
Not reported
Not reported
Not reported
Not reported
Photophobia
Values in Patient-cycle · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
All Patients
4
Not reported
Not reported
Not reported
Not reported
Platelet Count Decrease
Values in Patient-cycle · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
All Patients
92
Not reported
Not reported
Not reported
Not reported
Pruritis
Values in Patient-cycle · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
All Patients
4
Not reported
Not reported
Not reported
Not reported
Psychiatric Disorders
Values in Patient-cycle · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
All Patients
1
Not reported
Not reported
Not reported
Not reported
Respiratory Failure
Values in Patient-cycle · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
All Patients
1
Not reported
Not reported
Not reported
Not reported
Serum Amylase Increase
Values in Patient-cycle · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
All Patients
1
Not reported
Not reported
Not reported
Not reported
Skin Infection
Values in Patient-cycle · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
All Patients
1
Not reported
Not reported
Not reported
Not reported
Somnolence
Values in Patient-cycle · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
All Patients
2
Not reported
Not reported
Not reported
Not reported
Sore Throat
Values in Patient-cycle · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
All Patients
1
Not reported
Not reported
Not reported
Not reported
Tumor Lysis Syndrome
Values in Patient-cycle · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
All Patients
1
Not reported
Not reported
Not reported
Not reported
Upper Respiratory Infection
Values in Patient-cycle · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
All Patients
1
Not reported
Not reported
Not reported
Not reported
Urticaria
Values in Patient-cycle · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
All Patients
1
Not reported
Not reported
Not reported
Not reported
Urinary Tract Infection
Values in Patient-cycle · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
All Patients
4
Not reported
Not reported
Not reported
Not reported
Vomiting
Values in Patient-cycle · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
All Patients
1
Not reported
Not reported
Not reported
Not reported
White Blood Cell Decrease
Values in Patient-cycle · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
All Patients
163
Not reported
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
value
3
title
Abdominal Pain
categories
measurements
group Id
OG000
value
1
title
Prolonged Partial Thromboplatin Time
categories
measurements
group Id
OG000
value
1
title
Acute Kidney Injury
categories
measurements
group Id
OG000
value
1
title
Agitation
categories
measurements
group Id
OG000
value
25
title
Alanine Aminotransferase Elevation
categories
measurements
group Id
OG000
value
1
title
Allergic Reaction
categories
measurements
group Id
OG000
value
27
title
Alopecia
categories
measurements
group Id
OG000
value
1
title
Anal Mucocitis
categories
measurements
group Id
OG000
value
141
title
Anemia
categories
measurements
group Id
OG000
value
8
title
Anorexia
categories
measurements
group Id
OG000
value
15
title
Aspartate Aminotransferase Increase
categories
measurements
group Id
OG000
value
1
title
Back Pain
denoms
counts
group Id
OG000
value
116
units
Participants
description
The number of patient-cycles in which the adverse event considered grade 3 or higher AE according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 considered by the treating physician to be possibly, probably or definitely related to alisertib.
groups
description
All patients
id
OG000
title
All Patients
param Type
NUMBER
population Description
116 patients contributed 360 patient-cycles to the analysis.
reporting Status
POSTED
time Frame
Up to 24 months
title
Number of Patients Cycles With Grade 3 or Higher Adverse Event
Triangle