TriangleNCT01566695 · OUTCOME
Healthcare Resource Utilization (HRU): Number of Participants Who Were Hospitalized
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 date of randomization up to 28 days after the last dose of study drug; up to data cut off date of 25 January 2019; median duration of treatment to oral azacitaidine was 5.29 months and 5.36 months for placebo
What was measured
The number of reasons for hospitalizations and hospital admissions during the treatment period were monitored and include those associated with: AEs, protocol-driven procedures, transfusions, non-protocol procedures, elective procedures or those associated with social, practical or technical reasons in the absence of AEs. HRU was defined as any consumption of healthcare resources directly or indirectly related to the treatment of the patient.
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 | Source count |
|---|---|
| Oral Azacitidine and Best Supportive Care | 107 |
| Placebo Plus Best Supportive Care | 109 |
Reported measurements
Adverse Events
| 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 | 65 | Not reported | Not reported | Not reported | Not reported |
Protocol Driven Procedures
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Oral Azacitidine and Best Supportive Care | 2 | Not reported | Not reported | Not reported | Not reported |
| Placebo Plus Best Supportive Care | 7 | Not reported | Not reported | Not reported | Not reported |
Non-Protocol Driven Procedures
| 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 | 19 | Not reported | Not reported | Not reported | Not reported |
Transfusion
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Oral Azacitidine and Best Supportive Care | 32 | Not reported | Not reported | Not reported | Not reported |
| Placebo Plus Best Supportive Care | 33 | Not reported | Not reported | Not reported | Not reported |
Procedure Planned Prior to Signing Consent
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Oral Azacitidine and Best Supportive Care | 0 | Not reported | Not reported | Not reported | Not reported |
| Placebo Plus Best Supportive Care | 4 | Not reported | Not reported | Not reported | Not reported |
Elective Procedures
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Oral Azacitidine and Best Supportive Care | 4 | Not reported | Not reported | Not reported | Not reported |
| Placebo Plus Best Supportive Care | 10 | Not reported | Not reported | Not reported | Not reported |
Social, Technical or Practical Reason except AEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Oral Azacitidine and Best Supportive Care | 4 | Not reported | Not reported | Not reported | Not reported |
| Placebo Plus Best Supportive Care | 6 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 79
- group Id
- OG001
- value
- 65
- title
- Adverse Events
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 7
- title
- Protocol Driven Procedures
- categories
- measurements
- group Id
- OG000
- value
- 9
- group Id
- OG001
- value
- 19
- title
- Non-Protocol Driven Procedures
- categories
- measurements
- group Id
- OG000
- value
- 32
- group Id
- OG001
- value
- 33
- title
- Transfusion
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 4
- title
- Procedure Planned Prior to Signing Consent
- categories
- measurements
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 10
- title
- Elective Procedures
- categories
- measurements
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 6
- title
- Social, Technical or Practical Reason except AEs
- denoms
- counts
- group Id
- OG000
- value
- 107
- group Id
- OG001
- value
- 109
- units
- Participants
- description
- The number of reasons for hospitalizations and hospital admissions during the treatment period were monitored and include those associated with: AEs, protocol-driven procedures, transfusions, non-protocol procedures, elective procedures or those associated with social, practical or technical reasons in the absence of AEs. HRU was defined as any consumption of healthcare resources directly or indirectly related to the treatment of the patient.
- 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 date of randomization up to 28 days after the last dose of study drug; up to data cut off date of 25 January 2019; median duration of treatment to oral azacitaidine was 5.29 months and 5.36 months for placebo
- title
- Healthcare Resource Utilization (HRU): Number of Participants Who Were Hospitalized
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice