NCT01871727 · OUTCOME
Main Study Part: Time to Reach Maximum (Peak) Concentration After Drug Administration (Tmax)
A Trial of E7777 in Persistent and Recurrent Cutaneous T-Cell Lymphoma · Source last updated 2024-11-13
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- minutes
- Interval / dispersion
- Full Range
- Time frame
- Cycles 1, 3 and 5 Day 1: Pre-dose up to 300 hours post-dose (Cycle length was 21 days)
Analysis population: Main study part PK analysis set included all participants from whom at least one quantifiable concentration of E7777 was observed at 9 mcg/kg dose (both Main Study and Lead-In). Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure. Here "number analyzed" signifies participants who were evaluable for this outcome measure at given time points.
Groups in this outcome
Main Study Part: E7777 9 mcg/kg
Participants with stages I to III CTCL were treated with E7777 9 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part and in Main study part and were presented together here, as planned.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Main Study Part: E7777 9 mcg/kg | 20 |
|---|
Reported measurements
Cycle 1 Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Main Study Part: E7777 9 mcg/kg | 20 |
|---|
Values in minutes · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Main Study Part: E7777 9 mcg/kg | 60 | Not reported | 28 | 180 | Not reported |
|---|
Cycle 3 Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Main Study Part: E7777 9 mcg/kg | 16 |
|---|
Values in minutes · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Main Study Part: E7777 9 mcg/kg | 60 | Not reported | 30 | 74 | Not reported |
|---|
Cycle 5 Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Main Study Part: E7777 9 mcg/kg | 12 |
|---|
Values in minutes · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Main Study Part: E7777 9 mcg/kg | 60 | Not reported | 30 | 64 | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 28
- upper Limit
- 180
- value
- 60
- title
- Cycle 1 Day 1
- categories
- measurements
- group Id
- OG000
- lower Limit
- 30
- upper Limit
- 74
- value
- 60
- title
- Cycle 3 Day 1
- categories
- measurements
- group Id
- OG000
- lower Limit
- 30
- upper Limit
- 64
- value
- 60
- title
- Cycle 5 Day 1
- dispersion Type
- Full Range
- groups
- description
- Participants with stages I to III CTCL were treated with E7777 9 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part and in Main study part and were presented together here, as planned.
- id
- OG000
- title
- Main Study Part: E7777 9 mcg/kg
- param Type
- MEDIAN
- population Description
- Main study part PK analysis set included all participants from whom at least one quantifiable concentration of E7777 was observed at 9 mcg/kg dose (both Main Study and Lead-In). Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure. Here "number analyzed" signifies participants who were evaluable for this outcome measure at given time points.
- reporting Status
- POSTED
- time Frame
- Cycles 1, 3 and 5 Day 1: Pre-dose up to 300 hours post-dose (Cycle length was 21 days)
- title
- Main Study Part: Time to Reach Maximum (Peak) Concentration After Drug Administration (Tmax)
- type
- SECONDARY
- unit Of Measure
- minutes
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
Triangle