TriangleNCT02281084 · OUTCOME
Percentage of Participants With Progressive Disease at Baseline Who Achieved Stable Disease
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percentage of Participants
- Interval / dispersion
- Not reported
- Time frame
- Response was assessed every 2 cycles following treatment during the first 6 cycles, then every 3 cycles thereafter; median duration of treatment = 5.26 and 3.81 months for SD/PD for oral AZA arms respectively, and 1.84 months for AZA and Durva SD/PD arms
What was measured
A participant was considered as having a stable disease if the disease neither responded nor progressed during or after study treatment.
Analysis population: Includes participants who had progressive disease at baseline who achieved stable disease.
Groups in this outcome
Stable Disease (SD) Cohort: Oral Azacitidine
Participants were given oral azacitidine (AZA) 100 mg, 150 mg, or 200 mg tablets twice daily (BID) on days 1 to 21 of each 28-day treatment cycle. Participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.
Progressive Disease (PD) Cohort: Oral Azacitidine
Participants were given oral azacitidine 100 mg, 150mg, or 200mg tablets BID on days 1 to 21 of each 28-day treatment cycle. Participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.
Stable Disease Cohort: Oral Azacitidine and Durvalumab
Participants received 100 mg oral azacitidine (AZA) tablets BID on days 1 to 14 or days 1 to 21 of each 28-day treatment cycle and durvalumab (Durva) 1500 mg by intravenous infusion on day 1 of each 28-day treatment cycle; participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.
Progressive Disease Cohort: Oral Azacitidine and Durvalumab
Participants received 100 mg oral azacitidine tablets BID on days 1 to 14 or days 1 to 21 of each 28-day treatment cycle and durvalumab 1500 mg by intravenous infusion on day 1 of each 28-day treatment cycle; participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.
| Group | Source count |
|---|---|
| Stable Disease (SD) Cohort: Oral Azacitidine | 0 |
| Progressive Disease (PD) Cohort: Oral Azacitidine | 22 |
| Stable Disease Cohort: Oral Azacitidine and Durvalumab | 0 |
| Progressive Disease Cohort: Oral Azacitidine and Durvalumab | 5 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Progressive Disease (PD) Cohort: Oral Azacitidine | 36.4 | Not reported | Not reported | Not reported | Not reported |
| Progressive Disease Cohort: Oral Azacitidine and Durvalumab | 20.0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG001
- value
- 36.4
- group Id
- OG003
- value
- 20.0
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 22
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 5
- units
- Participants
- description
- A participant was considered as having a stable disease if the disease neither responded nor progressed during or after study treatment.
- groups
- description
- Participants were given oral azacitidine (AZA) 100 mg, 150 mg, or 200 mg tablets twice daily (BID) on days 1 to 21 of each 28-day treatment cycle. Participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.
- id
- OG000
- title
- Stable Disease (SD) Cohort: Oral Azacitidine
- description
- Participants were given oral azacitidine 100 mg, 150mg, or 200mg tablets BID on days 1 to 21 of each 28-day treatment cycle. Participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.
- id
- OG001
- title
- Progressive Disease (PD) Cohort: Oral Azacitidine
- description
- Participants received 100 mg oral azacitidine (AZA) tablets BID on days 1 to 14 or days 1 to 21 of each 28-day treatment cycle and durvalumab (Durva) 1500 mg by intravenous infusion on day 1 of each 28-day treatment cycle; participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.
- id
- OG002
- title
- Stable Disease Cohort: Oral Azacitidine and Durvalumab
- description
- Participants received 100 mg oral azacitidine tablets BID on days 1 to 14 or days 1 to 21 of each 28-day treatment cycle and durvalumab 1500 mg by intravenous infusion on day 1 of each 28-day treatment cycle; participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.
- id
- OG003
- title
- Progressive Disease Cohort: Oral Azacitidine and Durvalumab
- param Type
- NUMBER
- population Description
- Includes participants who had progressive disease at baseline who achieved stable disease.
- reporting Status
- POSTED
- time Frame
- Response was assessed every 2 cycles following treatment during the first 6 cycles, then every 3 cycles thereafter; median duration of treatment = 5.26 and 3.81 months for SD/PD for oral AZA arms respectively, and 1.84 months for AZA and Durva SD/PD arms
- title
- Percentage of Participants With Progressive Disease at Baseline Who Achieved Stable Disease
- type
- SECONDARY
- unit Of Measure
- Percentage of Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice