TriangleNCT05185947 · OUTCOME
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
- Participants were followed from time of initiation of study treatment to death or last follow-up through study completion for 27 months, 14 days
What was measured
OS is defined as the time from the start of treatment until time of death from any cause, for up to 3 years after completion of therapy. OS will be reported using the Kaplan-Meier method, along with a 95% confidence interval.
Analysis population: 7/21 participants were analyzed because 12 participants 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 | 3.63 | Not reported | 2.53 | 8.31 | Not reported |
| Intravenous Paclitaxel DoseLevel -1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level 1 | 11.01 | Not reported | 11.01 | 11.01 | Not reported |
| Intravenous Paclitaxel DoseLevel 1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level -1 | 3.88 | Not reported | 3.88 | 3.88 | Not reported |
| Intravenous Paclitaxel DoseLevel -1, Intraperitoneal Paclitaxel DoseLevel 1, Nilotinib Dose Level -1 | 10.45 | Not reported | 10.45 | 10.45 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2.53
- upper Limit
- 8.31
- value
- 3.63
- group Id
- OG001
- lower Limit
- 11.01
- upper Limit
- 11.01
- value
- 11.01
- group Id
- OG002
- lower Limit
- 3.88
- upper Limit
- 3.88
- value
- 3.88
- group Id
- OG003
- lower Limit
- 10.45
- upper Limit
- 10.45
- value
- 10.45
- 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
- OS is defined as the time from the start of treatment until time of death from any cause, for up to 3 years after completion of therapy. OS will be reported using the Kaplan-Meier method, along with a 95% confidence interval.
- 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
- 7/21 participants were analyzed because 12 participants were not treated and 2 refused further treatment.
- reporting Status
- POSTED
- time Frame
- Participants were followed from time of initiation of study treatment to death or last follow-up through study completion for 27 months, 14 days
- title
- Overall Survival (OS)
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice