TriangleNCT00652626 · OUTCOME
Number of Participants With Adverse Events (AEs)
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
- Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
What was measured
A serious adverse event is one that at any dose of the study drug or at any time during the period of observation: * 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; * Is medically important. The Investigator assessed each AE for potential causal relationship between the event and study drug. The intensity of adverse changes in physical signs or symptoms was graded from 1 to 5 according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3, and according to the following: Mild (Grade 1), Moderate (Grade 2), Severe (Grade 3), Life threatening (Grade 4), or Death (Grade 5).
Analysis population: Safety population, all enrolled patients who received at least one dose of azacitidine and who had at least one post-treatment safety assessment.
Groups in this outcome
Azacitidine 25 mg/m^2
Participants with normal renal function (defined as creatinine clearance \> 80 mL/min/1.73m\^2) received a single subcutaneous dose of azacitidine 25 mg/m\^2 on Day 1.
Azacitidine 50 mg/m^2
Participants with normal renal function received a single subcutaneous dose of azacitidine 50 mg/m\^2 on Day 1.
Azacitidine 75 mg/m^2
Participants with normal renal function received subcutaneous doses of azacitidine 75 mg/m\^2 on Days 1 to 5.
Azacitidine 100 mg/m^2
Participants with normal renal function received a single subcutaneous dose of azacitidine 100 mg/m\^2 on Day 1.
Severe RI: Azacitidine 75 mg/m^2
Participants with severe renal impairment (RI; defined as creatinine clearance \< 30 mL/min/1.73 m\^2) received subcutaneous doses of azacitidine 75 mg/m\^2 on Days 1 to 5.
Extension Phase: Normal RF
Participants with normal renal function (RF) received up to 6 cycles of treatment with 75 mg/m\^2 azacitidine daily on Days 1-7 of each 28-day cycle.
Extension Phase: Severe RI
Participants with severe renal impairment (RI) received up to 6 cycles of treatment with 75 mg/m\^2 azacitidine daily on Days 1-7 of each 28-day cycle.
| Group | Source count |
|---|---|
| Azacitidine 25 mg/m^2 | 5 |
| Azacitidine 50 mg/m^2 | 5 |
| Azacitidine 75 mg/m^2 | 6 |
| Azacitidine 100 mg/m^2 | 5 |
| Severe RI: Azacitidine 75 mg/m^2 | 6 |
| Extension Phase: Normal RF | 14 |
| Extension Phase: Severe RI | 4 |
Reported measurements
Any adverse event
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Azacitidine 25 mg/m^2 | 4 | Not reported | Not reported | Not reported | Not reported |
| Azacitidine 50 mg/m^2 | 3 | Not reported | Not reported | Not reported | Not reported |
| Azacitidine 75 mg/m^2 | 6 | Not reported | Not reported | Not reported | Not reported |
| Azacitidine 100 mg/m^2 | 5 | Not reported | Not reported | Not reported | Not reported |
| Severe RI: Azacitidine 75 mg/m^2 | 6 | Not reported | Not reported | Not reported | Not reported |
| Extension Phase: Normal RF | 14 | Not reported | Not reported | Not reported | Not reported |
| Extension Phase: Severe RI | 4 | Not reported | Not reported | Not reported | Not reported |
Adverse event related to study drug
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Azacitidine 25 mg/m^2 | 2 | Not reported | Not reported | Not reported | Not reported |
| Azacitidine 50 mg/m^2 | 3 | Not reported | Not reported | Not reported | Not reported |
| Azacitidine 75 mg/m^2 | 4 | Not reported | Not reported | Not reported | Not reported |
| Azacitidine 100 mg/m^2 | 4 | Not reported | Not reported | Not reported | Not reported |
| Severe RI: Azacitidine 75 mg/m^2 | 3 | Not reported | Not reported | Not reported | Not reported |
| Extension Phase: Normal RF | 8 | Not reported | Not reported | Not reported | Not reported |
| Extension Phase: Severe RI | 2 | Not reported | Not reported | Not reported | Not reported |
Serious adverse event
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Azacitidine 25 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Azacitidine 50 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Azacitidine 75 mg/m^2 | 4 | Not reported | Not reported | Not reported | Not reported |
| Azacitidine 100 mg/m^2 | 1 | Not reported | Not reported | Not reported | Not reported |
| Severe RI: Azacitidine 75 mg/m^2 | 1 | Not reported | Not reported | Not reported | Not reported |
| Extension Phase: Normal RF | 8 | Not reported | Not reported | Not reported | Not reported |
| Extension Phase: Severe RI | 3 | Not reported | Not reported | Not reported | Not reported |
Serious adverse event related to study drug
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Azacitidine 25 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Azacitidine 50 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Azacitidine 75 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Azacitidine 100 mg/m^2 | 1 | Not reported | Not reported | Not reported | Not reported |
| Severe RI: Azacitidine 75 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Extension Phase: Normal RF | 1 | Not reported | Not reported | Not reported | Not reported |
| Extension Phase: Severe RI | 1 | Not reported | Not reported | Not reported | Not reported |
Grade 3 or 4 adverse event
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Azacitidine 25 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Azacitidine 50 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Azacitidine 75 mg/m^2 | 4 | Not reported | Not reported | Not reported | Not reported |
| Azacitidine 100 mg/m^2 | 1 | Not reported | Not reported | Not reported | Not reported |
| Severe RI: Azacitidine 75 mg/m^2 | 3 | Not reported | Not reported | Not reported | Not reported |
| Extension Phase: Normal RF | 10 | Not reported | Not reported | Not reported | Not reported |
| Extension Phase: Severe RI | 3 | Not reported | Not reported | Not reported | Not reported |
AE leading to study drug discontinuation
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Azacitidine 25 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Azacitidine 50 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Azacitidine 75 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Azacitidine 100 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Severe RI: Azacitidine 75 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Extension Phase: Normal RF | 4 | Not reported | Not reported | Not reported | Not reported |
| Extension Phase: Severe RI | 2 | Not reported | Not reported | Not reported | Not reported |
AE leading to study drug interruption
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Azacitidine 25 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Azacitidine 50 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Azacitidine 75 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Azacitidine 100 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Severe RI: Azacitidine 75 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Extension Phase: Normal RF | 4 | Not reported | Not reported | Not reported | Not reported |
| Extension Phase: Severe RI | 1 | Not reported | Not reported | Not reported | Not reported |
AE leading to a dose reduction
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Azacitidine 25 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Azacitidine 50 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Azacitidine 75 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Azacitidine 100 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Severe RI: Azacitidine 75 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Extension Phase: Normal RF | 1 | Not reported | Not reported | Not reported | Not reported |
| Extension Phase: Severe RI | 0 | Not reported | Not reported | Not reported | Not reported |
AE leading to other action taken
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Azacitidine 25 mg/m^2 | 2 | Not reported | Not reported | Not reported | Not reported |
| Azacitidine 50 mg/m^2 | 1 | Not reported | Not reported | Not reported | Not reported |
| Azacitidine 75 mg/m^2 | 6 | Not reported | Not reported | Not reported | Not reported |
| Azacitidine 100 mg/m^2 | 4 | Not reported | Not reported | Not reported | Not reported |
| Severe RI: Azacitidine 75 mg/m^2 | 5 | Not reported | Not reported | Not reported | Not reported |
| Extension Phase: Normal RF | 10 | Not reported | Not reported | Not reported | Not reported |
| Extension Phase: Severe RI | 3 | Not reported | Not reported | Not reported | Not reported |
Death
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Azacitidine 25 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Azacitidine 50 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Azacitidine 75 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Azacitidine 100 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Severe RI: Azacitidine 75 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Extension Phase: Normal RF | 1 | Not reported | Not reported | Not reported | Not reported |
| Extension Phase: Severe RI | 1 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 5
- group Id
- OG004
- value
- 6
- group Id
- OG005
- value
- 14
- group Id
- OG006
- value
- 4
- title
- Any adverse event
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 4
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 8
- group Id
- OG006
- value
- 2
- title
- Adverse event related to study drug
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 8
- group Id
- OG006
- value
- 3
- title
- Serious adverse event
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 1
- group Id
- OG006
- value
- 1
- title
- Serious adverse event related to study drug
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 10
- group Id
- OG006
- value
- 3
- title
- Grade 3 or 4 adverse event
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 4
- group Id
- OG006
- value
- 2
- title
- AE leading to study drug discontinuation
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 4
- group Id
- OG006
- value
- 1
- title
- AE leading to study drug interruption
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 1
- group Id
- OG006
- value
- 0
- title
- AE leading to a dose reduction
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 4
- group Id
- OG004
- value
- 5
- group Id
- OG005
- value
- 10
- group Id
- OG006
- value
- 3
- title
- AE leading to other action taken
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 1
- group Id
- OG006
- value
- 1
- title
- Death
- denoms
- counts
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 5
- group Id
- OG004
- value
- 6
- group Id
- OG005
- value
- 14
- group Id
- OG006
- value
- 4
- units
- Participants
- description
- A serious adverse event is one that at any dose of the study drug or at any time during the period of observation: * 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; * Is medically important. The Investigator assessed each AE for potential causal relationship between the event and study drug. The intensity of adverse changes in physical signs or symptoms was graded from 1 to 5 according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3, and according to the following: Mild (Grade 1), Moderate (Grade 2), Severe (Grade 3), Life threatening (Grade 4), or Death (Grade 5).
- groups
- description
- Participants with normal renal function (defined as creatinine clearance \> 80 mL/min/1.73m\^2) received a single subcutaneous dose of azacitidine 25 mg/m\^2 on Day 1.
- id
- OG000
- title
- Azacitidine 25 mg/m^2
- description
- Participants with normal renal function received a single subcutaneous dose of azacitidine 50 mg/m\^2 on Day 1.
- id
- OG001
- title
- Azacitidine 50 mg/m^2
- description
- Participants with normal renal function received subcutaneous doses of azacitidine 75 mg/m\^2 on Days 1 to 5.
- id
- OG002
- title
- Azacitidine 75 mg/m^2
- description
- Participants with normal renal function received a single subcutaneous dose of azacitidine 100 mg/m\^2 on Day 1.
- id
- OG003
- title
- Azacitidine 100 mg/m^2
- description
- Participants with severe renal impairment (RI; defined as creatinine clearance \< 30 mL/min/1.73 m\^2) received subcutaneous doses of azacitidine 75 mg/m\^2 on Days 1 to 5.
- id
- OG004
- title
- Severe RI: Azacitidine 75 mg/m^2
- description
- Participants with normal renal function (RF) received up to 6 cycles of treatment with 75 mg/m\^2 azacitidine daily on Days 1-7 of each 28-day cycle.
- id
- OG005
- title
- Extension Phase: Normal RF
- description
- Participants with severe renal impairment (RI) received up to 6 cycles of treatment with 75 mg/m\^2 azacitidine daily on Days 1-7 of each 28-day cycle.
- id
- OG006
- title
- Extension Phase: Severe RI
- param Type
- NUMBER
- population Description
- Safety population, all enrolled patients who received at least one dose of azacitidine and who had at least one post-treatment safety assessment.
- reporting Status
- POSTED
- time Frame
- Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
- title
- Number of Participants With Adverse Events (AEs)
- type
- PRIMARY
- unit Of Measure
- participants
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Preserved source evidence · Not medical advice