TriangleNCT02281084 · OUTCOME
Kaplan-Meier Estimate of Progression Free Survival (PFS)
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
- From first dose to the first documented progressive disease (PD), relapse, or death due to any cause (Up to 91 months)
What was measured
Progression-free survival is defined as the time from first dose to the first documented progressive disease (PD), relapse, or death due to any cause during or after the treatment period, whichever occurred first, according to IWG 2006 response criteria for MDS. Participants who were still alive and progression-free were censored at the date of their last response assessment. Progressive disease is defined as follows: - an increase in BM blasts relative to nadir: •If nadir less than 5% blasts: ≥ 50% increase in blasts to \> 5% blasts •If nadir 5% - 10% blasts: ≥ 50% increase in blasts to \> 10% blasts •If nadir 10% - 20% blasts: ≥ 50% increase in blasts to \> 20% blasts •If nadir 20% - 30% blasts: ≥ 50% increase in blasts to \> 30% blasts And any of the following: •At least 50% decrement from maximum remission/response levels in granulocytes or platelets •Reduction in Hgb concentration by ≥ 2 g/dL •Transfusion dependence
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
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Stable Disease (SD) Cohort: Oral Azacitidine | 14.86 | Not reported | 9.27 | 24.99 | Not reported |
| Progressive Disease (PD) Cohort: Oral Azacitidine | 6.28 | Not reported | 4.50 | 15.19 | Not reported |
| Stable Disease Cohort: Oral Azacitidine and Durvalumab | 14.70 | Not reported | 1.58 | NA | Could not be estimated due to the insufficient number of events. |
| Progressive Disease Cohort: Oral Azacitidine and Durvalumab | 12.10 | Not reported | 2.17 | NA | Could not be estimated due to the insufficient number of events. |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 9.27
- upper Limit
- 24.99
- value
- 14.86
- group Id
- OG001
- lower Limit
- 4.50
- upper Limit
- 15.19
- value
- 6.28
- comment
- Could not be estimated due to the insufficient number of events.
- group Id
- OG002
- lower Limit
- 1.58
- upper Limit
- NA
- value
- 14.70
- comment
- Could not be estimated due to the insufficient number of events.
- group Id
- OG003
- lower Limit
- 2.17
- upper Limit
- NA
- value
- 12.10
- 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
- Progression-free survival is defined as the time from first dose to the first documented progressive disease (PD), relapse, or death due to any cause during or after the treatment period, whichever occurred first, according to IWG 2006 response criteria for MDS. Participants who were still alive and progression-free were censored at the date of their last response assessment. Progressive disease is defined as follows: - an increase in BM blasts relative to nadir: •If nadir less than 5% blasts: ≥ 50% increase in blasts to \> 5% blasts •If nadir 5% - 10% blasts: ≥ 50% increase in blasts to \> 10% blasts •If nadir 10% - 20% blasts: ≥ 50% increase in blasts to \> 20% blasts •If nadir 20% - 30% blasts: ≥ 50% increase in blasts to \> 30% blasts And any of the following: •At least 50% decrement from maximum remission/response levels in granulocytes or platelets •Reduction in Hgb concentration by ≥ 2 g/dL •Transfusion dependence
- 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
- From first dose to the first documented progressive disease (PD), relapse, or death due to any cause (Up to 91 months)
- title
- Kaplan-Meier Estimate of Progression Free Survival (PFS)
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice