TriangleNCT02113878 · OUTCOME
24 Month Overall Survival
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- probability of survival
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Up to 24 months
What was measured
The probability of survival at 24 months using Kaplan-Meier estimates. Patients alive at 2 years are censored at 2 years.
Groups in this outcome
Dose Level 1
* 40 mg BKM120 will be administered orally daily for 45 days. Starting dose 40 mg. * Cisplatin: Starting Dose 30 mg/m2, given IV, weekly on days: (1, 8, 15, 22, 29, 36 and 43). * Radiotherapy: All participants will receive daily radiotherapy with intensity-modulated radiotherapy (IMRT) for 7 weeks. BKM120: BKM120 is a potent and highly specific oral pan-class I PI3K inhibitor. Cisplatin: Cisplatin is a chemotherapy drug Intensity-modulated radiotherapy (IMRT): IMRT is the medical use of ionizing radiation, generally as part of cancer treatment to control or kill malignant cells
Dose Level 2
* 40 mg BKM120 will be administered orally daily for 45 days. * Cisplatin: Starting Dose 35 mg/m2, given IV, weekly on days: (1, 8, 15, 22, 29, 36 and 43). * Radiotherapy: All participants will receive daily radiotherapy with intensity-modulated radiotherapy (IMRT) for 7 weeks. BKM120: BKM120 is a potent and highly specific oral pan-class I PI3K inhibitor. Cisplatin: Cisplatin is a chemotherapy drug Intensity-modulated radiotherapy (IMRT): IMRT is the medical use of ionizing radiation, generally as part of cancer treatment to control or kill malignant cells
| Group | Source count |
|---|---|
| Dose Level 1 | 17 |
| Dose Level 2 | 6 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Level 1 | 0.929 | Not reported | 0.591 | 0.99 | Not reported |
| Dose Level 2 | 0.240 | Not reported | 0.239 | 0.246 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.591
- upper Limit
- 0.99
- value
- 0.929
- group Id
- OG001
- lower Limit
- 0.239
- upper Limit
- 0.246
- value
- 0.240
- denoms
- counts
- group Id
- OG000
- value
- 17
- group Id
- OG001
- value
- 6
- units
- Participants
- description
- The probability of survival at 24 months using Kaplan-Meier estimates. Patients alive at 2 years are censored at 2 years.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- * 40 mg BKM120 will be administered orally daily for 45 days. Starting dose 40 mg. * Cisplatin: Starting Dose 30 mg/m2, given IV, weekly on days: (1, 8, 15, 22, 29, 36 and 43). * Radiotherapy: All participants will receive daily radiotherapy with intensity-modulated radiotherapy (IMRT) for 7 weeks. BKM120: BKM120 is a potent and highly specific oral pan-class I PI3K inhibitor. Cisplatin: Cisplatin is a chemotherapy drug Intensity-modulated radiotherapy (IMRT): IMRT is the medical use of ionizing radiation, generally as part of cancer treatment to control or kill malignant cells
- id
- OG000
- title
- Dose Level 1
- description
- * 40 mg BKM120 will be administered orally daily for 45 days. * Cisplatin: Starting Dose 35 mg/m2, given IV, weekly on days: (1, 8, 15, 22, 29, 36 and 43). * Radiotherapy: All participants will receive daily radiotherapy with intensity-modulated radiotherapy (IMRT) for 7 weeks. BKM120: BKM120 is a potent and highly specific oral pan-class I PI3K inhibitor. Cisplatin: Cisplatin is a chemotherapy drug Intensity-modulated radiotherapy (IMRT): IMRT is the medical use of ionizing radiation, generally as part of cancer treatment to control or kill malignant cells
- id
- OG001
- title
- Dose Level 2
- param Type
- NUMBER
- reporting Status
- POSTED
- time Frame
- Up to 24 months
- title
- 24 Month Overall Survival
- type
- SECONDARY
- unit Of Measure
- probability of survival
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice