TriangleNCT02281084 · OUTCOME
Kaplan Meier Estimate of Time to Onset of First and Best Response
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Months
- Interval / dispersion
- 95% Confidence Interval
- 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
Time to onset of first response was defined as the time between the date of first investigational product (IP) dose and the earliest date any response (CR, PR, mCR, or HI) was first observed. Participants who did not achieve any defined response during the treatment period were censored at the date of treatment discontinuation, disease progression, or death, whichever occurred first. Best response is the best recorded response or treatment outcome from the start of the study treatment until the end of the study treatment taking into account the requirements for confirmation of response.
Analysis population: The ITT population included all enrolled participants who received at least one dose of IP.
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 | 32 |
| Progressive Disease (PD) Cohort: Oral Azacitidine | 22 |
| Stable Disease Cohort: Oral Azacitidine and Durvalumab | 6 |
| Progressive Disease Cohort: Oral Azacitidine and Durvalumab | 5 |
Reported measurements
Onset of First Response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Stable Disease (SD) Cohort: Oral Azacitidine | NA | Not reported | 10.85 | NA | Could not be estimated due to the insufficient number of events. |
| Progressive Disease (PD) Cohort: Oral Azacitidine | 11.97 | Not reported | NA | NA | Could not be estimated due to the insufficient number of events. |
| Stable Disease Cohort: Oral Azacitidine and Durvalumab | NA | Not reported | 1.64 | NA | Could not be estimated due to the insufficient number of events. |
| Progressive Disease Cohort: Oral Azacitidine and Durvalumab | NA | Not reported | NA | NA | Could not be estimated due to the insufficient number of events. |
Onset of Best Response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Stable Disease (SD) Cohort: Oral Azacitidine | 3.68 | Not reported | 2.10 | NA | Could not be estimated due to the insufficient number of events. |
| Progressive Disease (PD) Cohort: Oral Azacitidine | 4.41 | Not reported | 1.68 | NA | Could not be estimated due to the insufficient number of events. |
| Stable Disease Cohort: Oral Azacitidine and Durvalumab | 3.29 | Not reported | 1.64 | NA | Could not be estimated due to the insufficient number of events. |
| Progressive Disease Cohort: Oral Azacitidine and Durvalumab | 2.17 | Not reported | 1.64 | NA | Could not be estimated due to the insufficient number of events. |
Complete source fields
- classes
- categories
- measurements
- comment
- Could not be estimated due to the insufficient number of events.
- group Id
- OG000
- lower Limit
- 10.85
- upper Limit
- NA
- value
- NA
- comment
- Could not be estimated due to the insufficient number of events.
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- 11.97
- comment
- Could not be estimated due to the insufficient number of events.
- group Id
- OG002
- lower Limit
- 1.64
- upper Limit
- NA
- value
- NA
- comment
- Could not be estimated due to the insufficient number of events.
- group Id
- OG003
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- title
- Onset of First Response
- categories
- measurements
- comment
- Could not be estimated due to the insufficient number of events.
- group Id
- OG000
- lower Limit
- 2.10
- upper Limit
- NA
- value
- 3.68
- comment
- Could not be estimated due to the insufficient number of events.
- group Id
- OG001
- lower Limit
- 1.68
- upper Limit
- NA
- value
- 4.41
- comment
- Could not be estimated due to the insufficient number of events.
- group Id
- OG002
- lower Limit
- 1.64
- upper Limit
- NA
- value
- 3.29
- comment
- Could not be estimated due to the insufficient number of events.
- group Id
- OG003
- lower Limit
- 1.64
- upper Limit
- NA
- value
- 2.17
- title
- Onset of Best Response
- denoms
- counts
- group Id
- OG000
- value
- 32
- group Id
- OG001
- value
- 22
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 5
- units
- Participants
- description
- Time to onset of first response was defined as the time between the date of first investigational product (IP) dose and the earliest date any response (CR, PR, mCR, or HI) was first observed. Participants who did not achieve any defined response during the treatment period were censored at the date of treatment discontinuation, disease progression, or death, whichever occurred first. Best response is the best recorded response or treatment outcome from the start of the study treatment until the end of the study treatment taking into account the requirements for confirmation of response.
- dispersion Type
- 95% Confidence Interval
- 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
- MEDIAN
- population Description
- The ITT population included all enrolled participants who received at least one dose of IP.
- 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
- Kaplan Meier Estimate of Time to Onset of First and Best Response
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice