TriangleNCT00412061 · OUTCOME
Overall Survival Using Kaplan-Meier Methodology
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
- 95% Confidence Interval
- Time frame
- Months 12, 24, 36, 48
What was measured
Overall survival was defined as the time from the date of randomization to the date of death from any cause. If a patient was not known to have died, survival was censored at the date of last contact. Kaplan-Meier methodology was used to estimate the median overall survival for each treatment group.
Analysis population: The Full Analysis Set (FAS; Intent-to-treat Population) consists of all randomized patients.
Groups in this outcome
Octreotide+ Everolimus
Everolimus was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity. Each treatment cycle lasted 28 days. Patients received their first dose of everolimus at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1, Day 1.
Octreotide+ Placebo Followed by Open Label Arm
Matching placebo was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity; Each treatment cycle lasted 28 days. Patients received their first dose of matching placebo at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1 Day 1. Open Label - Patients who had progressive disease in this arm, can move to the open label Everolimus + depot octreotide by choice.
| Group | Source count |
|---|---|
| Octreotide+ Everolimus | 216 |
| Octreotide+ Placebo Followed by Open Label Arm | 213 |
Reported measurements
12 Months
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Octreotide+ Everolimus | 80.5 | Not reported | 74.5 | 85.3 | Not reported |
| Octreotide+ Placebo Followed by Open Label Arm | 81.8 | Not reported | 75.8 | 86.4 | Not reported |
24 Months
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Octreotide+ Everolimus | 57.0 | Not reported | 49.9 | 63.4 | Not reported |
| Octreotide+ Placebo Followed by Open Label Arm | 63.6 | Not reported | 56.6 | 69.8 | Not reported |
36 Months
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Octreotide+ Everolimus | 42.9 | Not reported | 36.0 | 49.6 | Not reported |
| Octreotide+ Placebo Followed by Open Label Arm | 48.5 | Not reported | 41.4 | 55.3 | Not reported |
48 Months
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Octreotide+ Everolimus | 38.0 | Not reported | 31.2 | 44.7 | Not reported |
| Octreotide+ Placebo Followed by Open Label Arm | 41.6 | Not reported | 34.6 | 48.5 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 74.5
- upper Limit
- 85.3
- value
- 80.5
- group Id
- OG001
- lower Limit
- 75.8
- upper Limit
- 86.4
- value
- 81.8
- title
- 12 Months
- categories
- measurements
- group Id
- OG000
- lower Limit
- 49.9
- upper Limit
- 63.4
- value
- 57.0
- group Id
- OG001
- lower Limit
- 56.6
- upper Limit
- 69.8
- value
- 63.6
- title
- 24 Months
- categories
- measurements
- group Id
- OG000
- lower Limit
- 36.0
- upper Limit
- 49.6
- value
- 42.9
- group Id
- OG001
- lower Limit
- 41.4
- upper Limit
- 55.3
- value
- 48.5
- title
- 36 Months
- categories
- measurements
- group Id
- OG000
- lower Limit
- 31.2
- upper Limit
- 44.7
- value
- 38.0
- group Id
- OG001
- lower Limit
- 34.6
- upper Limit
- 48.5
- value
- 41.6
- title
- 48 Months
- denoms
- counts
- group Id
- OG000
- value
- 216
- group Id
- OG001
- value
- 213
- units
- Participants
- description
- Overall survival was defined as the time from the date of randomization to the date of death from any cause. If a patient was not known to have died, survival was censored at the date of last contact. Kaplan-Meier methodology was used to estimate the median overall survival for each treatment group.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Everolimus was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity. Each treatment cycle lasted 28 days. Patients received their first dose of everolimus at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1, Day 1.
- id
- OG000
- title
- Octreotide+ Everolimus
- description
- Matching placebo was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity; Each treatment cycle lasted 28 days. Patients received their first dose of matching placebo at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1 Day 1. Open Label - Patients who had progressive disease in this arm, can move to the open label Everolimus + depot octreotide by choice.
- id
- OG001
- title
- Octreotide+ Placebo Followed by Open Label Arm
- param Type
- NUMBER
- population Description
- The Full Analysis Set (FAS; Intent-to-treat Population) consists of all randomized patients.
- reporting Status
- POSTED
- time Frame
- Months 12, 24, 36, 48
- title
- Overall Survival Using Kaplan-Meier Methodology
- type
- SECONDARY
- unit Of Measure
- Percentage of Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice