TriangleNCT05185947 · OUTCOME
Median Overall Survival (OS)
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 time of initiation of study treatment to death or last follow-up, a median of 5.60 months
What was measured
Kaplan-Meier method will be used to evaluate median overall OS and will be reported with a 95% confidence interval. Overall survival (OS) is defined as the time from the start of the treatment until time of death from any cause, for up to 3 years after completion of therapy, assessed every 3 months (±2 weeks).
Analysis population: 6/21 participants were analyzed because one participant was alive at last contact, including at study closure,12 were not treated and 2 refused further treatment.
Groups in this outcome
Intravenous Paclitaxel Dose Level 1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level 1
Ended treatment at the regular dose level: 80 intravenous (IV)/80 Intraperitoneal (IP) + 300 twice a day (BID).
Intravenous Paclitaxel DoseLevel -1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level 1
Had the planned doses for Intraperitoneal (IP) Paclitaxel (80 IP) and by mouth (PO) nilotinib (300 twice a day (BID) but declined to go up to the 80mg/m\^2 of intravenous (IV) Paclitaxel.
Intravenous Paclitaxel DoseLevel 1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level -1
Had the planned doses for intravenous (IV) and Intraperitoneal (IP) Paclitaxel (80 IV/80 IP) but had a dose reduction for Nilotinib (400 every day (QD).
Intravenous Paclitaxel DoseLevel -1, Intraperitoneal Paclitaxel DoseLevel 1, Nilotinib Dose Level -1
Had the planned dose of Intraperitoneal (IP) Paclitaxel (80 IP) but had a dose reduction for intravenous (IV) Paclitaxel (60 IV), and a dose reduction for Nilotinib (400 every day (QD).
| Group | Source count |
|---|---|
| Intravenous Paclitaxel Dose Level 1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level 1 | 4 |
| Intravenous Paclitaxel DoseLevel -1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level 1 | 1 |
| Intravenous Paclitaxel DoseLevel 1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level -1 | 1 |
| Intravenous Paclitaxel DoseLevel -1, Intraperitoneal Paclitaxel DoseLevel 1, Nilotinib Dose Level -1 | 1 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Intravenous Paclitaxel Dose Level 1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level 1 | 3.779 | Not reported | 3.751 | 3.779 | Not reported |
| Intravenous Paclitaxel DoseLevel -1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level 1 | NA | Not reported | NA | NA | Participant was alive at last contact. |
| Intravenous Paclitaxel DoseLevel 1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level -1 | 2.826 | Not reported | 2.826 | 2.826 | Not reported |
| Intravenous Paclitaxel DoseLevel -1, Intraperitoneal Paclitaxel DoseLevel 1, Nilotinib Dose Level -1 | 10.218 | Not reported | 10.218 | 10.218 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 3.751
- upper Limit
- 3.779
- value
- 3.779
- comment
- Participant was alive at last contact.
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- group Id
- OG002
- lower Limit
- 2.826
- upper Limit
- 2.826
- value
- 2.826
- group Id
- OG003
- lower Limit
- 10.218
- upper Limit
- 10.218
- value
- 10.218
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 1
- units
- Participants
- description
- Kaplan-Meier method will be used to evaluate median overall OS and will be reported with a 95% confidence interval. Overall survival (OS) is defined as the time from the start of the treatment until time of death from any cause, for up to 3 years after completion of therapy, assessed every 3 months (±2 weeks).
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Ended treatment at the regular dose level: 80 intravenous (IV)/80 Intraperitoneal (IP) + 300 twice a day (BID).
- id
- OG000
- title
- Intravenous Paclitaxel Dose Level 1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level 1
- description
- Had the planned doses for Intraperitoneal (IP) Paclitaxel (80 IP) and by mouth (PO) nilotinib (300 twice a day (BID) but declined to go up to the 80mg/m\^2 of intravenous (IV) Paclitaxel.
- id
- OG001
- title
- Intravenous Paclitaxel DoseLevel -1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level 1
- description
- Had the planned doses for intravenous (IV) and Intraperitoneal (IP) Paclitaxel (80 IV/80 IP) but had a dose reduction for Nilotinib (400 every day (QD).
- id
- OG002
- title
- Intravenous Paclitaxel DoseLevel 1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level -1
- description
- Had the planned dose of Intraperitoneal (IP) Paclitaxel (80 IP) but had a dose reduction for intravenous (IV) Paclitaxel (60 IV), and a dose reduction for Nilotinib (400 every day (QD).
- id
- OG003
- title
- Intravenous Paclitaxel DoseLevel -1, Intraperitoneal Paclitaxel DoseLevel 1, Nilotinib Dose Level -1
- param Type
- MEDIAN
- population Description
- 6/21 participants were analyzed because one participant was alive at last contact, including at study closure,12 were not treated and 2 refused further treatment.
- reporting Status
- POSTED
- time Frame
- From time of initiation of study treatment to death or last follow-up, a median of 5.60 months
- title
- Median Overall Survival (OS)
- type
- SECONDARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice