TriangleNCT02676778 · OUTCOME
Rac (AUC): Accumulation Ratio of AUC for E7777
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- ratio
- Interval / dispersion
- Standard Deviation
- Time frame
- Cycle 1 Day 1: 0-240 minutes post-infusion; Cycle 3 and 5 Day 1: 0-120 minutes post-infusion (each Cycle length = 3 weeks)
What was measured
Accumulation ratio of AUC was calculated as RAC (AUC) on Cycle 3 Day 1 divided by RAC (AUC) on Cycle 1 Day 1, and RAC (AUC) on Cycle 5 Day 1 divided by RAC (AUC) on Cycle 1 Day 1.
Analysis population: PK analysis set: group of participants who received at least 1 dose of study drug with at least 1 serum concentration data, and included participants who had taken frequent blood sampling for non-compartment analysis. Overall number of participants analyzed is number of participants with evaluable data at Cycle 1 Day 1 and at Cycles 3 and 5 Day 1
Groups in this outcome
PTCL and CTCL Participants: E7777 9 mcg/kg/Day
Participants with relapsed or refractory PTCL and CTCL received E7777 9 mcg/kg/day as intravenous infusion, once daily from Day 1 through Day 5 in each treatment cycle until discontinuation or Cycle 8 (each Cycle length = 3 weeks).
| Group | Source count |
|---|---|
| PTCL and CTCL Participants: E7777 9 mcg/kg/Day | 1 |
Reported measurements
Cycle 3 Day 1
| Group | Source count |
|---|---|
| PTCL and CTCL Participants: E7777 9 mcg/kg/Day | 0 |
Cycle 5 Day 1
| Group | Source count |
|---|---|
| PTCL and CTCL Participants: E7777 9 mcg/kg/Day | 1 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| PTCL and CTCL Participants: E7777 9 mcg/kg/Day | 0.827 | NA | Not reported | Not reported | Standard deviation could not be calculated because only one participant was analysed. |
Complete source fields
- classes
- denoms
- counts
- group Id
- OG000
- value
- 0
- units
- Participants
- title
- Cycle 3 Day 1
- categories
- measurements
- comment
- Standard deviation could not be calculated because only one participant was analysed.
- group Id
- OG000
- spread
- NA
- value
- 0.827
- denoms
- counts
- group Id
- OG000
- value
- 1
- units
- Participants
- title
- Cycle 5 Day 1
- denoms
- counts
- group Id
- OG000
- value
- 1
- units
- Participants
- description
- Accumulation ratio of AUC was calculated as RAC (AUC) on Cycle 3 Day 1 divided by RAC (AUC) on Cycle 1 Day 1, and RAC (AUC) on Cycle 5 Day 1 divided by RAC (AUC) on Cycle 1 Day 1.
- dispersion Type
- Standard Deviation
- groups
- description
- Participants with relapsed or refractory PTCL and CTCL received E7777 9 mcg/kg/day as intravenous infusion, once daily from Day 1 through Day 5 in each treatment cycle until discontinuation or Cycle 8 (each Cycle length = 3 weeks).
- id
- OG000
- title
- PTCL and CTCL Participants: E7777 9 mcg/kg/Day
- param Type
- MEAN
- population Description
- PK analysis set: group of participants who received at least 1 dose of study drug with at least 1 serum concentration data, and included participants who had taken frequent blood sampling for non-compartment analysis. Overall number of participants analyzed is number of participants with evaluable data at Cycle 1 Day 1 and at Cycles 3 and 5 Day 1
- reporting Status
- POSTED
- time Frame
- Cycle 1 Day 1: 0-240 minutes post-infusion; Cycle 3 and 5 Day 1: 0-120 minutes post-infusion (each Cycle length = 3 weeks)
- title
- Rac (AUC): Accumulation Ratio of AUC for E7777
- type
- SECONDARY
- unit Of Measure
- ratio
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice