Number of Participants in the Extension Phase With Treatment Emergent Adverse Events (TEAEs)
Study of Vidaza Versus Conventional Care Regimens for the Treatment of Acute Myeloid Leukemia (AML) · Source last updated 2017-08-29
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
Measure
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
From the date of informed consent for the Extension Phase through to the date of last dose of study drug + 28 days up to last visit completed 24 July 2016; maximum duration of exposure to Azacitidine was 871 days
What was measured
AEs = any noxious, unintended, or untoward medical occurrence that may appear or worsen during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, regardless of cause. Serious AE (SAE) = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. The severity of AEs were graded based upon the participants symptoms according to the Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0); AEs were evaluated for severity according to the following scale: Grade 1 = Mild - transient or mild discomfort; no medical intervention required; Grade 2 = Moderate - mild to moderate limitation in activity; Grade 3 = Severe; Grade 4 = Life threatening; Grade 5 = Death
Analysis population: Safety population includes those enrolled in the extension phase who received at least one dose of study drug.
Groups in this outcome
Azacitidine (AZA)
Azacitidine 75 mg/m2/day by subcutaneous injection \[SC\] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion.
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
Azacitidine (AZA)
22
Reported measurements
At least one Treatment Emergent AE
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Azacitidine (AZA)
20
Not reported
Not reported
Not reported
Not reported
At least one TEAE related to study drug
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Azacitidine (AZA)
13
Not reported
Not reported
Not reported
Not reported
At least one Grade 3-4 adverse event
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Azacitidine (AZA)
13
Not reported
Not reported
Not reported
Not reported
At least 1 Grade 3-4 TEAE related to study drug
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Azacitidine (AZA)
7
Not reported
Not reported
Not reported
Not reported
At least 1 Grade 5 TEAE
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Azacitidine (AZA)
4
Not reported
Not reported
Not reported
Not reported
At least 1 Grade 5 TEAE related to study drug
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Azacitidine (AZA)
0
Not reported
Not reported
Not reported
Not reported
At least 1 serious TEAE
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Azacitidine (AZA)
10
Not reported
Not reported
Not reported
Not reported
At least 1 serious TEAE related to study drug
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Azacitidine (AZA)
1
Not reported
Not reported
Not reported
Not reported
At least one serious Grade 3-4 TEAE
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Azacitidine (AZA)
8
Not reported
Not reported
Not reported
Not reported
TEAE leading to discontinuation of study drug
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Azacitidine (AZA)
3
Not reported
Not reported
Not reported
Not reported
Study drug-related TEAE leading to discontinuation
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Azacitidine (AZA)
1
Not reported
Not reported
Not reported
Not reported
TEAE leading to study drug dose reduction
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Azacitidine (AZA)
1
Not reported
Not reported
Not reported
Not reported
TEAE leading to study drug dose interruption only
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Azacitidine (AZA)
17
Not reported
Not reported
Not reported
Not reported
TEAE causing study dose reduction/interruption
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Azacitidine (AZA)
2
Not reported
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
value
20
title
At least one Treatment Emergent AE
categories
measurements
group Id
OG000
value
13
title
At least one TEAE related to study drug
categories
measurements
group Id
OG000
value
13
title
At least one Grade 3-4 adverse event
categories
measurements
group Id
OG000
value
7
title
At least 1 Grade 3-4 TEAE related to study drug
categories
measurements
group Id
OG000
value
4
title
At least 1 Grade 5 TEAE
categories
measurements
group Id
OG000
value
0
title
At least 1 Grade 5 TEAE related to study drug
categories
measurements
group Id
OG000
value
10
title
At least 1 serious TEAE
categories
measurements
group Id
OG000
value
1
title
At least 1 serious TEAE related to study drug
categories
measurements
group Id
OG000
value
8
title
At least one serious Grade 3-4 TEAE
categories
measurements
group Id
OG000
value
3
title
TEAE leading to discontinuation of study drug
categories
measurements
group Id
OG000
value
1
title
Study drug-related TEAE leading to discontinuation
categories
measurements
group Id
OG000
value
1
title
TEAE leading to study drug dose reduction
denom Units Selected
participants
denoms
counts
group Id
OG000
value
22
units
Participants
description
AEs = any noxious, unintended, or untoward medical occurrence that may appear or worsen during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, regardless of cause. Serious AE (SAE) = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. The severity of AEs were graded based upon the participants symptoms according to the Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0); AEs were evaluated for severity according to the following scale: Grade 1 = Mild - transient or mild discomfort; no medical intervention required; Grade 2 = Moderate - mild to moderate limitation in activity; Grade 3 = Severe; Grade 4 = Life threatening; Grade 5 = Death
groups
description
Azacitidine 75 mg/m2/day by subcutaneous injection \[SC\] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion.
id
OG000
title
Azacitidine (AZA)
param Type
NUMBER
population Description
Safety population includes those enrolled in the extension phase who received at least one dose of study drug.
reporting Status
POSTED
time Frame
From the date of informed consent for the Extension Phase through to the date of last dose of study drug + 28 days up to last visit completed 24 July 2016; maximum duration of exposure to Azacitidine was 871 days
title
Number of Participants in the Extension Phase With Treatment Emergent Adverse Events (TEAEs)
Triangle