TriangleNCT00071799 · OUTCOME
Number of Participants in Different Categories of Adverse Experiences During Core Study Period
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
- Day 1 (randomization) to 42 months
What was measured
Patient counts for a variety of subsets of adverse experiences for the core study period (day 1 to 42 months). The individual options for Conventional Care Regimens (Best Supportive Care Only, Low-Dose Cytarabine, and Standard Chemotherapy) are presented as separate treatments.
Analysis population: Safety population excludes 4 Azacitidine patients, 3 Best Supportive Care Only patients, 5 Low-dose Cytarabine patients, and 6 Standard Chemotherapy patients who were randomized/assigned to those regimens but did not receive treatment.
Groups in this outcome
Azacitidine
Azacitidine, 75 mg/m2/day given by subcutaneous injection for 7 days of every 28 day cycle, plus best supportive care.
Best Supportive Care Only
Care can include transfusions, antibiotics, myeloid growth factors \[G-CSF and GM CSF\] for neutropenic infections until the end of the study.
Low-dose Cytarabine
Cytarabine, 20 mg/m2/day subcutaneously on Days 1-14, with 28-42 days between cycles. Plus best supportive care.
Standard Chemotherapy
Induction cycle: Cytarabine infusion 100-200 mg/m2/day on days 1-7 + anthracycline on days 1, 2, 3 Consolidation cycle: Cytarabine infusion 100-200 mg/m2/day for 3-7 days + anthracycline on days 1 and 2 There are 28-70 days between cycles - 1 induction cycle and maximum of 2 consolidation cycles; best supportive care follows the final consolidation cycle.
| Group | Source count |
|---|---|
| Azacitidine | 175 |
| Best Supportive Care Only | 102 |
| Low-dose Cytarabine | 44 |
| Standard Chemotherapy | 19 |
Reported measurements
Patients with >=1 treatment emergent AE (TEAE)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Azacitidine | 175 | Not reported | Not reported | Not reported | Not reported |
| Best Supportive Care Only | 97 | Not reported | Not reported | Not reported | Not reported |
| Low-dose Cytarabine | 44 | Not reported | Not reported | Not reported | Not reported |
| Standard Chemotherapy | 19 | Not reported | Not reported | Not reported | Not reported |
Patients with >=1 treatment related TEAE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Azacitidine | 169 | Not reported | Not reported | Not reported | Not reported |
| Best Supportive Care Only | 1 | Not reported | Not reported | Not reported | Not reported |
| Low-dose Cytarabine | 34 | Not reported | Not reported | Not reported | Not reported |
| Standard Chemotherapy | 19 | Not reported | Not reported | Not reported | Not reported |
Patients with >=1 serious TEAE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Azacitidine | 114 | Not reported | Not reported | Not reported | Not reported |
| Best Supportive Care Only | 71 | Not reported | Not reported | Not reported | Not reported |
| Low-dose Cytarabine | 27 | Not reported | Not reported | Not reported | Not reported |
| Standard Chemotherapy | 14 | Not reported | Not reported | Not reported | Not reported |
Patients with >=1 serious treatment related TEAE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Azacitidine | 43 | Not reported | Not reported | Not reported | Not reported |
| Best Supportive Care Only | 0 | Not reported | Not reported | Not reported | Not reported |
| Low-dose Cytarabine | 13 | Not reported | Not reported | Not reported | Not reported |
| Standard Chemotherapy | 13 | Not reported | Not reported | Not reported | Not reported |
Patients w TEAE leading to discontinued treatment
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Azacitidine | 22 | Not reported | Not reported | Not reported | Not reported |
| Best Supportive Care Only | 4 | Not reported | Not reported | Not reported | Not reported |
| Low-dose Cytarabine | 6 | Not reported | Not reported | Not reported | Not reported |
| Standard Chemotherapy | 2 | Not reported | Not reported | Not reported | Not reported |
Patients w TEAE leading to dose reduction
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Azacitidine | 20 | Not reported | Not reported | Not reported | Not reported |
| Best Supportive Care Only | 0 | Not reported | Not reported | Not reported | Not reported |
| Low-dose Cytarabine | 2 | Not reported | Not reported | Not reported | Not reported |
| Standard Chemotherapy | 0 | Not reported | Not reported | Not reported | Not reported |
Patients w TEAE leading to dose interruption
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Azacitidine | 82 | Not reported | Not reported | Not reported | Not reported |
| Best Supportive Care Only | 0 | Not reported | Not reported | Not reported | Not reported |
| Low-dose Cytarabine | 12 | Not reported | Not reported | Not reported | Not reported |
| Standard Chemotherapy | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 175
- group Id
- OG001
- value
- 97
- group Id
- OG002
- value
- 44
- group Id
- OG003
- value
- 19
- title
- Patients with >=1 treatment emergent AE (TEAE)
- categories
- measurements
- group Id
- OG000
- value
- 169
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 34
- group Id
- OG003
- value
- 19
- title
- Patients with >=1 treatment related TEAE
- categories
- measurements
- group Id
- OG000
- value
- 114
- group Id
- OG001
- value
- 71
- group Id
- OG002
- value
- 27
- group Id
- OG003
- value
- 14
- title
- Patients with >=1 serious TEAE
- categories
- measurements
- group Id
- OG000
- value
- 43
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 13
- group Id
- OG003
- value
- 13
- title
- Patients with >=1 serious treatment related TEAE
- categories
- measurements
- group Id
- OG000
- value
- 22
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 2
- title
- Patients w TEAE leading to discontinued treatment
- categories
- measurements
- group Id
- OG000
- value
- 20
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 0
- title
- Patients w TEAE leading to dose reduction
- categories
- measurements
- group Id
- OG000
- value
- 82
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 12
- group Id
- OG003
- value
- 0
- title
- Patients w TEAE leading to dose interruption
- denoms
- counts
- group Id
- OG000
- value
- 175
- group Id
- OG001
- value
- 102
- group Id
- OG002
- value
- 44
- group Id
- OG003
- value
- 19
- units
- Participants
- description
- Patient counts for a variety of subsets of adverse experiences for the core study period (day 1 to 42 months). The individual options for Conventional Care Regimens (Best Supportive Care Only, Low-Dose Cytarabine, and Standard Chemotherapy) are presented as separate treatments.
- groups
- description
- Azacitidine, 75 mg/m2/day given by subcutaneous injection for 7 days of every 28 day cycle, plus best supportive care.
- id
- OG000
- title
- Azacitidine
- description
- Care can include transfusions, antibiotics, myeloid growth factors \[G-CSF and GM CSF\] for neutropenic infections until the end of the study.
- id
- OG001
- title
- Best Supportive Care Only
- description
- Cytarabine, 20 mg/m2/day subcutaneously on Days 1-14, with 28-42 days between cycles. Plus best supportive care.
- id
- OG002
- title
- Low-dose Cytarabine
- description
- Induction cycle: Cytarabine infusion 100-200 mg/m2/day on days 1-7 + anthracycline on days 1, 2, 3 Consolidation cycle: Cytarabine infusion 100-200 mg/m2/day for 3-7 days + anthracycline on days 1 and 2 There are 28-70 days between cycles - 1 induction cycle and maximum of 2 consolidation cycles; best supportive care follows the final consolidation cycle.
- id
- OG003
- title
- Standard Chemotherapy
- param Type
- NUMBER
- population Description
- Safety population excludes 4 Azacitidine patients, 3 Best Supportive Care Only patients, 5 Low-dose Cytarabine patients, and 6 Standard Chemotherapy patients who were randomized/assigned to those regimens but did not receive treatment.
- reporting Status
- POSTED
- time Frame
- Day 1 (randomization) to 42 months
- title
- Number of Participants in Different Categories of Adverse Experiences During Core Study Period
- type
- SECONDARY
- unit Of Measure
- participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice