NCT01757535 · OUTCOME
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Efficacy of Oral Azacitidine Plus Best Supportive Care as Maintenance Therapy in Subjects With Acute Myeloid Leukemia (AML) in Complete Remission · Source last updated 2025-07-08
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 day 1 (randomization) up to data cut off date of 06 August 2024; approximately 135.5 months
What was measured
TEAEs include AEs that started between first dose date and 28 days after the last dose of study drug. A serious adverse event (SAE) is: • Death • Life-threatening event • Inpatient hospitalization or prolongation of existing hospitalization • Persistent or significant disability or incapacity • Congenital anomaly or birth defect • Other important medical event The severity of AEs were assessed by the investigator according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0: Grade 1 (Mild): asymptomatic/mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 (Moderate): minimal, local or noninvasive intervention indicated; limiting age-appropriate activities of daily living. Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care Grade 4: Life-threatening; urgent intervention indicated. Grade 5: Death due to AE.
Analysis population: The safety population included all randomized participants who received at least 1 dose of study drug.
Groups in this outcome
Oral Azacitidine Plus Best Supportive Care
Participants received 300 mg azacitidine tablets once a day (QD) for the first 14 days of each 28-day treatment cycle until discontinuation, which includes the following reasons: disease relapse, withdrawal of consent, adverse events, participant became eligible for allogeneic bone marrow or stem cell transplantation during the treatment period, death, lost to follow-up, or protocol violation or until the end of the study.
Placebo Plus Best Supportive Care
Participants received identically matching placebo tablets QD for the first 14 days of each 28-day treatment cycle until no longer receiving benefit, withdrawal of consent, disease relapse, adverse events, participant became eligible for allogeneic bone marrow or stem cell transplantation during the treatment period, lost to follow-up, or protocol violation or until the end of the study.
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 Plus Best Supportive Care | 236 |
|---|
| Placebo Plus Best Supportive Care | 233 |
|---|
Reported measurements
≥ 1 TEAE
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Oral Azacitidine Plus Best Supportive Care | 235 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo Plus Best Supportive Care | 233 | Not reported | Not reported | Not reported | Not reported |
|---|
≥ 1 TEAE Related to Study Treatment
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Oral Azacitidine Plus Best Supportive Care | 213 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo Plus Best Supportive Care | 121 | 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 Plus Best Supportive Care | 110 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo Plus Best Supportive Care | 109 | Not reported | Not reported | Not reported | Not reported |
|---|
≥ 1 Treatment Related Serious TEAE
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Oral Azacitidine Plus Best Supportive Care | 22 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo Plus Best Supportive Care | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
≥ 1 Grade 3/4 TEAE
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Oral Azacitidine Plus Best Supportive Care | 207 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo Plus Best Supportive Care | 201 | Not reported | Not reported | Not reported | Not reported |
|---|
≥ 1 Treatment Related Grade 3/4 TEAE
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Oral Azacitidine Plus Best Supportive Care | 113 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo Plus Best Supportive Care | 55 | 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 Plus Best Supportive Care | 15 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo Plus Best Supportive Care | 11 | Not reported | Not reported | Not reported | Not reported |
|---|
≥ 1 TEAE Leading to Dose Reduction (Red)
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Oral Azacitidine Plus Best Supportive Care | 37 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo Plus Best Supportive Care | 6 | 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 Plus Best Supportive Care | 107 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo Plus Best Supportive Care | 43 | Not reported | Not reported | Not reported | Not reported |
|---|
≥ 1 TEAE Leading to Dose Red and Interruption
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Oral Azacitidine Plus Best Supportive Care | 25 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo Plus Best Supportive Care | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
≥ 1 TEAE Leading to Study Drug Discontinuation
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Oral Azacitidine Plus Best Supportive Care | 155 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo Plus Best Supportive Care | 170 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 235
- group Id
- OG001
- value
- 233
- title
- ≥ 1 TEAE
- categories
- measurements
- group Id
- OG000
- value
- 213
- group Id
- OG001
- value
- 121
- title
- ≥ 1 TEAE Related to Study Treatment
- categories
- measurements
- group Id
- OG000
- value
- 110
- group Id
- OG001
- value
- 109
- title
- ≥ 1 Serious TEAE
- categories
- measurements
- group Id
- OG000
- value
- 22
- group Id
- OG001
- value
- 5
- title
- ≥ 1 Treatment Related Serious TEAE
- categories
- measurements
- group Id
- OG000
- value
- 207
- group Id
- OG001
- value
- 201
- title
- ≥ 1 Grade 3/4 TEAE
- categories
- measurements
- group Id
- OG000
- value
- 113
- group Id
- OG001
- value
- 55
- title
- ≥ 1 Treatment Related Grade 3/4 TEAE
- categories
- measurements
- group Id
- OG000
- value
- 15
- group Id
- OG001
- value
- 11
- title
- ≥ 1 TEAE Leading to Death
- categories
- measurements
- group Id
- OG000
- value
- 37
- group Id
- OG001
- value
- 6
- title
- ≥ 1 TEAE Leading to Dose Reduction (Red)
- categories
- measurements
- group Id
- OG000
- value
- 107
- group Id
- OG001
- value
- 43
- title
- ≥ 1 TEAE Leading to Dose Interruption
- categories
- measurements
- group Id
- OG000
- value
- 25
- group Id
- OG001
- value
- 3
- title
- ≥ 1 TEAE Leading to Dose Red and Interruption
- categories
- measurements
- group Id
- OG000
- value
- 155
- group Id
- OG001
- value
- 170
- title
- ≥ 1 TEAE Leading to Study Drug Discontinuation
- denoms
- counts
- group Id
- OG000
- value
- 236
- group Id
- OG001
- value
- 233
- units
- Participants
- description
- TEAEs include AEs that started between first dose date and 28 days after the last dose of study drug. A serious adverse event (SAE) is: • Death • Life-threatening event • Inpatient hospitalization or prolongation of existing hospitalization • Persistent or significant disability or incapacity • Congenital anomaly or birth defect • Other important medical event The severity of AEs were assessed by the investigator according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0: Grade 1 (Mild): asymptomatic/mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 (Moderate): minimal, local or noninvasive intervention indicated; limiting age-appropriate activities of daily living. Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care Grade 4: Life-threatening; urgent intervention indicated. Grade 5: Death due to AE.
- groups
- description
- Participants received 300 mg azacitidine tablets once a day (QD) for the first 14 days of each 28-day treatment cycle until discontinuation, which includes the following reasons: disease relapse, withdrawal of consent, adverse events, participant became eligible for allogeneic bone marrow or stem cell transplantation during the treatment period, death, lost to follow-up, or protocol violation or until the end of the study.
- id
- OG000
- title
- Oral Azacitidine Plus Best Supportive Care
- description
- Participants received identically matching placebo tablets QD for the first 14 days of each 28-day treatment cycle until no longer receiving benefit, withdrawal of consent, disease relapse, adverse events, participant became eligible for allogeneic bone marrow or stem cell transplantation during the treatment period, lost to follow-up, or protocol violation or until the end of the study.
- id
- OG001
- title
- Placebo Plus Best Supportive Care
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- The safety population included all randomized participants who received at least 1 dose of study drug.
- reporting Status
- POSTED
- time Frame
- From day 1 (randomization) up to data cut off date of 06 August 2024; approximately 135.5 months
- title
- Number of Participants With Treatment Emergent Adverse Events (TEAEs)
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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