TriangleNCT02592551 · 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
- Participants will be followed up until death or censor for 2 year after surgery
What was measured
OS based on the Kaplan-Meier method is defined as the time between treatment and death or censored and participants in either MEDI-4736 alone or MEDI-4736+Tremelimumab will be followed up for 2 years after surgery.
Groups in this outcome
MEDI4736
8 patients will receive an infusion of MEDI4736 (15 mg/kg intravenously, once), one to six weeks prior to surgical resection. MEDI4736: MEDI4736 is formulated at 50 mg/mL in 26 mM histidine/histidine-HCl, 275 mM trehalose dihydrate, 0.02% (w/v) polysorbate 80, pH 6.0.
MEDI4736 + Tremelimumab
8 patients will receive an infusion of MEDI4736 (1500 mg intravenously, once) + tremelimumab (75mg intravenously, once), one to six weeks prior to surgical resection. MEDI4736: MEDI4736 is formulated at 50 mg/mL in 26 mM histidine/histidine-HCl, 275 mM trehalose dihydrate, 0.02% (w/v) polysorbate 80, pH 6.0. Tremelimumab: Tremelimumab Drug Product is formulated at a nominal concentration of 20 mg/mL in 20 mM histidine/histidine hydrochloride, 222 mM trehalose dihydrate, 0.02% (weight/volume \[w/v\]) polysorbate 80, 0.27 mM disodium edetate dihydrate (EDTA), pH 5.5.
| Group | Source count |
|---|---|
| MEDI4736 | 8 |
| MEDI4736 + Tremelimumab | 8 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| MEDI4736 | 14.4 | Not reported | 1 | 27 | Not reported |
| MEDI4736 + Tremelimumab | NA | Not reported | 5.0 | NA | The median survival was NA because there were more than 50% survival in the group. The upper 95% confidence limit of the survival curve hasn't reached 50%, there is no estimates for the upper confidence limit on the median. |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1
- upper Limit
- 27
- value
- 14.4
- comment
- The median survival was NA because there were more than 50% survival in the group. The upper 95% confidence limit of the survival curve hasn't reached 50%, there is no estimates for the upper confidence limit on the median.
- group Id
- OG001
- lower Limit
- 5.0
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 8
- group Id
- OG001
- value
- 8
- units
- Participants
- description
- OS based on the Kaplan-Meier method is defined as the time between treatment and death or censored and participants in either MEDI-4736 alone or MEDI-4736+Tremelimumab will be followed up for 2 years after surgery.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- 8 patients will receive an infusion of MEDI4736 (15 mg/kg intravenously, once), one to six weeks prior to surgical resection. MEDI4736: MEDI4736 is formulated at 50 mg/mL in 26 mM histidine/histidine-HCl, 275 mM trehalose dihydrate, 0.02% (w/v) polysorbate 80, pH 6.0.
- id
- OG000
- title
- MEDI4736
- description
- 8 patients will receive an infusion of MEDI4736 (1500 mg intravenously, once) + tremelimumab (75mg intravenously, once), one to six weeks prior to surgical resection. MEDI4736: MEDI4736 is formulated at 50 mg/mL in 26 mM histidine/histidine-HCl, 275 mM trehalose dihydrate, 0.02% (w/v) polysorbate 80, pH 6.0. Tremelimumab: Tremelimumab Drug Product is formulated at a nominal concentration of 20 mg/mL in 20 mM histidine/histidine hydrochloride, 222 mM trehalose dihydrate, 0.02% (weight/volume \[w/v\]) polysorbate 80, 0.27 mM disodium edetate dihydrate (EDTA), pH 5.5.
- id
- OG001
- title
- MEDI4736 + Tremelimumab
- param Type
- MEDIAN
- reporting Status
- POSTED
- time Frame
- Participants will be followed up until death or censor for 2 year after surgery
- title
- Median Overall Survival (OS)
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice