TriangleNCT00920556 · OUTCOME
Change From Baseline in Biochemistry: Prothrombin Time (PT)/ International Normalized Ratio (INR)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- Ratio of PT/INR
- Interval / dispersion
- Standard Deviation
- Time frame
- Baseline (Day 1) and End of Study assessments/follow-up approximately 28 days (+/- 7 days) following the last dose of SRT501 or SRT501 and bortezomib (approximately 280 days)
What was measured
Blood samples were collected to evaluate the biochemistry parameter PT/INR. Change from Baseline was defined as the value of Baseline minus from the End of study visit. Baseline was defined as Day 1.
Analysis population: Safety Population. Only those participants available at the particular timepoints were analyzed
Groups in this outcome
SRT501 Monotherapy
The eligible participants in this arm received 5 g of SRT501, oral suspension every morning at the same time approximately 15-30 minutes following consumption of breakfast) on all dosing days, for 20 consecutive days in a 21-day cycle for a maximum period of 12 cycles. There was no time between the cycles i.e Day 1 of a cycle was started on the day following Day 21 of the previous cycle. SRT501 was not administered on Day 21 of each cycle.
SRT501 + Bortezomib
The eligible participants in this arm received an intravenous solution of Bortezomib at 1.3 mg/m\^2 in conjunction with SRT501 (5.0 g/day) daily dosing. Bortezomib was administered prior to breakfast and SRT501 administration, on Day 1, 4, 8 and 11 in every 21 day cycle. It was given as per the local institution's guidelines and standards of care.SRT501 + Bortezomib, is a subset of arm SRT501 monotherapy.
| Group | Source count |
|---|---|
| SRT501 Monotherapy | 13 |
| SRT501 + Bortezomib | 6 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| SRT501 Monotherapy | 0.11 | 0.41 | Not reported | Not reported | Not reported |
| SRT501 + Bortezomib | 0.05 | 0.16 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 0.41
- value
- 0.11
- group Id
- OG001
- spread
- 0.16
- value
- 0.05
- denoms
- counts
- group Id
- OG000
- value
- 13
- group Id
- OG001
- value
- 6
- units
- Participants
- description
- Blood samples were collected to evaluate the biochemistry parameter PT/INR. Change from Baseline was defined as the value of Baseline minus from the End of study visit. Baseline was defined as Day 1.
- dispersion Type
- Standard Deviation
- groups
- description
- The eligible participants in this arm received 5 g of SRT501, oral suspension every morning at the same time approximately 15-30 minutes following consumption of breakfast) on all dosing days, for 20 consecutive days in a 21-day cycle for a maximum period of 12 cycles. There was no time between the cycles i.e Day 1 of a cycle was started on the day following Day 21 of the previous cycle. SRT501 was not administered on Day 21 of each cycle.
- id
- OG000
- title
- SRT501 Monotherapy
- description
- The eligible participants in this arm received an intravenous solution of Bortezomib at 1.3 mg/m\^2 in conjunction with SRT501 (5.0 g/day) daily dosing. Bortezomib was administered prior to breakfast and SRT501 administration, on Day 1, 4, 8 and 11 in every 21 day cycle. It was given as per the local institution's guidelines and standards of care.SRT501 + Bortezomib, is a subset of arm SRT501 monotherapy.
- id
- OG001
- title
- SRT501 + Bortezomib
- param Type
- MEAN
- population Description
- Safety Population. Only those participants available at the particular timepoints were analyzed
- reporting Status
- POSTED
- time Frame
- Baseline (Day 1) and End of Study assessments/follow-up approximately 28 days (+/- 7 days) following the last dose of SRT501 or SRT501 and bortezomib (approximately 280 days)
- title
- Change From Baseline in Biochemistry: Prothrombin Time (PT)/ International Normalized Ratio (INR)
- type
- PRIMARY
- unit Of Measure
- Ratio of PT/INR
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice