Occurrence of Possibly Related Adverse Events (AEs)
A Study of Axitinib in Advanced Carcinoid Tumors · Source last updated 2018-10-02
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
Not reported
Time frame
12 Months
What was measured
Grade 2 through 4 toxicities considered at least possibly related to treatment. Percentage of participants affected per category. Safety assessments will consist of monitoring and recording all adverse events and serious adverse events, the regular monitoring of hematology and blood chemistry parameters and regular physical examinations. Adverse events will be evaluated continuously throughout the study. Safety and tolerability will be assessed according to the National Institute of Health/National Cancer Institute (NIH/NCI) Common Terminology Criteria for Adverse Events version 4 (CTCAE v4) available at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm.
Analysis population: All participants.
Groups in this outcome
Axitinib Administration
The investigational drug used in this study is axitinib, and is available as tablets.
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
Axitinib Administration
30
Reported measurements
Hypertension
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Axitinib Administration
87
Not reported
Not reported
Not reported
Not reported
Abdominal pain
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Axitinib Administration
17
Not reported
Not reported
Not reported
Not reported
Diarrhea
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Axitinib Administration
17
Not reported
Not reported
Not reported
Not reported
Nausea
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Axitinib Administration
13
Not reported
Not reported
Not reported
Not reported
Vomiting
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Axitinib Administration
7
Not reported
Not reported
Not reported
Not reported
Mucositis
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Axitinib Administration
3
Not reported
Not reported
Not reported
Not reported
Oral pain
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Axitinib Administration
3
Not reported
Not reported
Not reported
Not reported
Headache
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Axitinib Administration
20
Not reported
Not reported
Not reported
Not reported
Confusion
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Axitinib Administration
3
Not reported
Not reported
Not reported
Not reported
Insomnia
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Axitinib Administration
3
Not reported
Not reported
Not reported
Not reported
Syncope
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Axitinib Administration
3
Not reported
Not reported
Not reported
Not reported
Anxiety
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Axitinib Administration
3
Not reported
Not reported
Not reported
Not reported
Intracranial hemorrhage
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Axitinib Administration
3
Not reported
Not reported
Not reported
Not reported
Fatigue
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Axitinib Administration
27
Not reported
Not reported
Not reported
Not reported
Weight loss
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Axitinib Administration
6
Not reported
Not reported
Not reported
Not reported
Anorexia
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Axitinib Administration
3
Not reported
Not reported
Not reported
Not reported
Myalgia
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Axitinib Administration
3
Not reported
Not reported
Not reported
Not reported
Dehydration
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Axitinib Administration
10
Not reported
Not reported
Not reported
Not reported
Hypothyroidism
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Axitinib Administration
3
Not reported
Not reported
Not reported
Not reported
Increased transaminases
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Axitinib Administration
3
Not reported
Not reported
Not reported
Not reported
Increased alkaline phosphatase
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Axitinib Administration
10
Not reported
Not reported
Not reported
Not reported
Increased gamma-glutamyl transferase
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Axitinib Administration
3
Not reported
Not reported
Not reported
Not reported
Urinary tract infection
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Axitinib Administration
3
Not reported
Not reported
Not reported
Not reported
Right ventricular dysfunction
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Axitinib Administration
3
Not reported
Not reported
Not reported
Not reported
Pain in extremity
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Axitinib Administration
3
Not reported
Not reported
Not reported
Not reported
Hand-foot syndrome
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Axitinib Administration
2
Not reported
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
value
87
title
Hypertension
categories
measurements
group Id
OG000
value
17
title
Abdominal pain
categories
measurements
group Id
OG000
value
17
title
Diarrhea
categories
measurements
group Id
OG000
value
13
title
Nausea
categories
measurements
group Id
OG000
value
7
title
Vomiting
categories
measurements
group Id
OG000
value
3
title
Mucositis
categories
measurements
group Id
OG000
value
3
title
Oral pain
categories
measurements
group Id
OG000
value
20
title
Headache
categories
measurements
group Id
OG000
value
3
title
Confusion
categories
measurements
group Id
OG000
value
3
title
Insomnia
categories
measurements
group Id
OG000
value
3
title
Syncope
categories
measurements
group Id
OG000
value
3
title
Anxiety
denoms
counts
group Id
OG000
value
30
units
Participants
description
Grade 2 through 4 toxicities considered at least possibly related to treatment. Percentage of participants affected per category. Safety assessments will consist of monitoring and recording all adverse events and serious adverse events, the regular monitoring of hematology and blood chemistry parameters and regular physical examinations. Adverse events will be evaluated continuously throughout the study. Safety and tolerability will be assessed according to the National Institute of Health/National Cancer Institute (NIH/NCI) Common Terminology Criteria for Adverse Events version 4 (CTCAE v4) available at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm.
groups
description
The investigational drug used in this study is axitinib, and is available as tablets.
id
OG000
title
Axitinib Administration
param Type
NUMBER
population Description
All participants.
reporting Status
POSTED
time Frame
12 Months
title
Occurrence of Possibly Related Adverse Events (AEs)
Triangle