Number of Participants With Treatment Emergent Adverse Events (TEAE)
The Efficacy and Safety of Oral Azacitidine Plus Best Supportive Care Versus Placebo and Best Supportive Care in Subjects With Red Blood Cell (RBC) Transfusion-Dependent Anemia and Thrombocytopenia Due to International Prognostic Scoring System (IPSS) Low Risk Myelodysplastic Syndrome (MDS) · Source last updated 2025-01-07
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
From first dose of IP up to 28 days after the last dose of IP or until the last study visit; up to a maximum of approximately 6 months on study
What was measured
A TEAE was defined as an adverse event that begins or worsens in intensity of frequency on or after the first dose of study drug through 28 days after last dose of study drug. A serious adverse event (SAE) is any: • Death; • Life-threatening event; • Any inpatient hospitalization or prolongation of existing hospitalization; • Persistent or significant disability or incapacity; • Congenital anomaly or birth defect; • Any other important medical event The investigator determined the relationship of an AE to study drug based on the timing of the AE relative to drug administration and whether or not other drugs, therapeutic interventions, or underlying conditions could provide a sufficient explanation for the event. The severity of an AE was evaluated by the investigator according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) (Version 4.0) where Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Life-threatening and Grade 5 = Death.
Analysis population: The safety population includes all randomized participants who received at least one dose of study drug.
Groups in this outcome
Oral Azacitidine and Best Supportive Care
Participants received 300 mg oral azacitidine tablets daily on days 1 to 21 of each 28-day treatment cycle and BSC included and was not limited to pRBC (packed red blood cell \[pRBC\] and whole blood), platelet transfusions (single donor or pooled donor), antibiotic, antiviral and/or antifungal therapy, nutritional support, and granulocyte colony stimulating factors (G-CSF) for participants who experienced neutropenic fever/infections.
Placebo Plus Best Supportive Care
Participants received identically matching placebo tablets QD on days 1 to 21 of each 28-day treatment cycle and BSC which included but was not limited to, pRBC and whole blood, platelet transfusions (single donor or pooled donor), antibiotic, antiviral and/or antifungal therapy, nutritional support, and G-CSF for participants who experienced neutropenic fever/infections.
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
Oral Azacitidine and Best Supportive Care
107
Placebo Plus Best Supportive Care
109
Reported measurements
≥ 1 TEAE
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Oral Azacitidine and Best Supportive Care
107
Not reported
Not reported
Not reported
Not reported
Placebo Plus Best Supportive Care
108
Not reported
Not reported
Not reported
Not reported
≥ 1 TEAE Related to Study Drug
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Oral Azacitidine and Best Supportive Care
102
Not reported
Not reported
Not reported
Not reported
Placebo Plus Best Supportive Care
54
Not reported
Not reported
Not reported
Not reported
≥ 1 Serious TEAE
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Oral Azacitidine and Best Supportive Care
83
Not reported
Not reported
Not reported
Not reported
Placebo Plus Best Supportive Care
69
Not reported
Not reported
Not reported
Not reported
≥ 1 Serious TEAE Related to Study Drug
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Oral Azacitidine and Best Supportive Care
38
Not reported
Not reported
Not reported
Not reported
Placebo Plus Best Supportive Care
8
Not reported
Not reported
Not reported
Not reported
≥ 1 Grade (GR) 3-4 TEAE
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Oral Azacitidine and Best Supportive Care
98
Not reported
Not reported
Not reported
Not reported
Placebo Plus Best Supportive Care
81
Not reported
Not reported
Not reported
Not reported
≥ 1 Grade 3-4 TEAE Related to Study Drug
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Oral Azacitidine and Best Supportive Care
73
Not reported
Not reported
Not reported
Not reported
Placebo Plus Best Supportive Care
20
Not reported
Not reported
Not reported
Not reported
≥ 1 Grade (GR) 3-4 Serious TEAE
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Oral Azacitidine and Best Supportive Care
79
Not reported
Not reported
Not reported
Not reported
Placebo Plus Best Supportive Care
56
Not reported
Not reported
Not reported
Not reported
≥ 1 GR 3-4 Serious TEAE Related to Study Drug
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Oral Azacitidine and Best Supportive Care
38
Not reported
Not reported
Not reported
Not reported
Placebo Plus Best Supportive Care
5
Not reported
Not reported
Not reported
Not reported
≥ 1 TEAE Leading to Death
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Oral Azacitidine and Best Supportive Care
25
Not reported
Not reported
Not reported
Not reported
Placebo Plus Best Supportive Care
14
Not reported
Not reported
Not reported
Not reported
≥ 1 TEAE Related to Study Drug Leading to Death
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Oral Azacitidine and Best Supportive Care
9
Not reported
Not reported
Not reported
Not reported
Placebo Plus Best Supportive Care
2
Not reported
Not reported
Not reported
Not reported
≥ 1 TEAE Leading to Dose Reduction
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Oral Azacitidine and Best Supportive Care
31
Not reported
Not reported
Not reported
Not reported
Placebo Plus Best Supportive Care
4
Not reported
Not reported
Not reported
Not reported
≥ 1 TEAE Leading to Dose Interruption
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Oral Azacitidine and Best Supportive Care
68
Not reported
Not reported
Not reported
Not reported
Placebo Plus Best Supportive Care
40
Not reported
Not reported
Not reported
Not reported
≥ 1 TEAE Leading to Dose Interruption/Reduction
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Oral Azacitidine and Best Supportive Care
29
Not reported
Not reported
Not reported
Not reported
Placebo Plus Best Supportive Care
2
Not reported
Not reported
Not reported
Not reported
≥ 1 TEAE Leading to Treatment Discontinuation
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Oral Azacitidine and Best Supportive Care
34
Not reported
Not reported
Not reported
Not reported
Placebo Plus Best Supportive Care
31
Not reported
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
value
107
group Id
OG001
value
108
title
≥ 1 TEAE
categories
measurements
group Id
OG000
value
102
group Id
OG001
value
54
title
≥ 1 TEAE Related to Study Drug
categories
measurements
group Id
OG000
value
83
group Id
OG001
value
69
title
≥ 1 Serious TEAE
categories
measurements
group Id
OG000
value
38
group Id
OG001
value
8
title
≥ 1 Serious TEAE Related to Study Drug
categories
measurements
group Id
OG000
value
98
group Id
OG001
value
81
title
≥ 1 Grade (GR) 3-4 TEAE
categories
measurements
group Id
OG000
value
73
group Id
OG001
value
20
title
≥ 1 Grade 3-4 TEAE Related to Study Drug
categories
measurements
group Id
OG000
value
79
group Id
OG001
value
56
title
≥ 1 Grade (GR) 3-4 Serious TEAE
categories
measurements
group Id
OG000
value
38
group Id
OG001
value
5
title
≥ 1 GR 3-4 Serious TEAE Related to Study Drug
categories
measurements
group Id
OG000
value
25
group Id
OG001
value
14
title
≥ 1 TEAE Leading to Death
categories
measurements
group Id
OG000
value
9
group Id
OG001
value
2
title
≥ 1 TEAE Related to Study Drug Leading to Death
categories
measurements
group Id
OG000
value
31
group Id
OG001
value
4
title
≥ 1 TEAE Leading to Dose Reduction
categories
measurements
group Id
OG000
value
68
group Id
OG001
value
40
title
≥ 1 TEAE Leading to Dose Interruption
denoms
counts
group Id
OG000
value
107
group Id
OG001
value
109
units
Participants
description
A TEAE was defined as an adverse event that begins or worsens in intensity of frequency on or after the first dose of study drug through 28 days after last dose of study drug. A serious adverse event (SAE) is any: • Death; • Life-threatening event; • Any inpatient hospitalization or prolongation of existing hospitalization; • Persistent or significant disability or incapacity; • Congenital anomaly or birth defect; • Any other important medical event The investigator determined the relationship of an AE to study drug based on the timing of the AE relative to drug administration and whether or not other drugs, therapeutic interventions, or underlying conditions could provide a sufficient explanation for the event. The severity of an AE was evaluated by the investigator according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) (Version 4.0) where Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Life-threatening and Grade 5 = Death.
groups
description
Participants received 300 mg oral azacitidine tablets daily on days 1 to 21 of each 28-day treatment cycle and BSC included and was not limited to pRBC (packed red blood cell \[pRBC\] and whole blood), platelet transfusions (single donor or pooled donor), antibiotic, antiviral and/or antifungal therapy, nutritional support, and granulocyte colony stimulating factors (G-CSF) for participants who experienced neutropenic fever/infections.
id
OG000
title
Oral Azacitidine and Best Supportive Care
description
Participants received identically matching placebo tablets QD on days 1 to 21 of each 28-day treatment cycle and BSC which included but was not limited to, pRBC and whole blood, platelet transfusions (single donor or pooled donor), antibiotic, antiviral and/or antifungal therapy, nutritional support, and G-CSF for participants who experienced neutropenic fever/infections.
id
OG001
title
Placebo Plus Best Supportive Care
param Type
COUNT_OF_PARTICIPANTS
population Description
The safety population includes all randomized participants who received at least one dose of study drug.
reporting Status
POSTED
time Frame
From first dose of IP up to 28 days after the last dose of IP or until the last study visit; up to a maximum of approximately 6 months on study
title
Number of Participants With Treatment Emergent Adverse Events (TEAE)
Triangle