NCT02676778 · OUTCOME
Number of Participants With Positive Anti-E7777 and Anti-IL-2 Antibodies
Study of E7777 in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma and Cutaneous T-cell Lymphoma · Source last updated 2021-07-15
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- Cycles 1, 2, 3, 5, 8: Day 1 pre-dose; at treatment discontinuation or completion (Cycle 8 Day 21) (each Cycle length = 3 weeks)
Analysis population: The pharmacodynamics (PD) analysis set was defined as a group of participants who received at least 1 dose of the study drug with at least 1 each of evaluable pre- and post-baseline PD data. Participants who were evaluable for this measure at given time point were included for the assessment.
Groups in this outcome
PTCL: E7777 9 mcg/kg/Day
Participants with relapsed or refractory PTCL 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).
CTCL: E7777 9 mcg/kg/Day
Participants with 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).
Other: E7777 9 mcg/kg/Day
Participant with extranodal NK/T-cell lymphoma 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 identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| PTCL: E7777 9 mcg/kg/Day | 17 |
|---|
| CTCL: E7777 9 mcg/kg/Day | 19 |
|---|
| Other: E7777 9 mcg/kg/Day | 1 |
|---|
Reported measurements
Anti-E7777 antibody: Cycle 1 Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| PTCL: E7777 9 mcg/kg/Day | 17 |
|---|
| CTCL: E7777 9 mcg/kg/Day | 19 |
|---|
| Other: E7777 9 mcg/kg/Day | 1 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| PTCL: E7777 9 mcg/kg/Day | 11 | Not reported | Not reported | Not reported | Not reported |
|---|
| CTCL: E7777 9 mcg/kg/Day | 13 | Not reported | Not reported | Not reported | Not reported |
|---|
| Other: E7777 9 mcg/kg/Day | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Anti-E7777 antibody: Cycle 2 Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| PTCL: E7777 9 mcg/kg/Day | 11 |
|---|
| CTCL: E7777 9 mcg/kg/Day | 14 |
|---|
| Other: E7777 9 mcg/kg/Day | 1 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| PTCL: E7777 9 mcg/kg/Day | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
| CTCL: E7777 9 mcg/kg/Day | 11 | Not reported | Not reported | Not reported | Not reported |
|---|
| Other: E7777 9 mcg/kg/Day | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Anti-E7777 antibody: Cycle 3 Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| PTCL: E7777 9 mcg/kg/Day | 8 |
|---|
| CTCL: E7777 9 mcg/kg/Day | 13 |
|---|
| Other: E7777 9 mcg/kg/Day | 0 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| PTCL: E7777 9 mcg/kg/Day | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
| CTCL: E7777 9 mcg/kg/Day | 11 | Not reported | Not reported | Not reported | Not reported |
|---|
Anti-E7777 antibody: Cycle 5 Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| PTCL: E7777 9 mcg/kg/Day | 4 |
|---|
| CTCL: E7777 9 mcg/kg/Day | 11 |
|---|
| Other: E7777 9 mcg/kg/Day | 0 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| PTCL: E7777 9 mcg/kg/Day | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| CTCL: E7777 9 mcg/kg/Day | 10 | Not reported | Not reported | Not reported | Not reported |
|---|
Anti-E7777 antibody: Cycle 8 Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| PTCL: E7777 9 mcg/kg/Day | 0 |
|---|
| CTCL: E7777 9 mcg/kg/Day | 7 |
|---|
| Other: E7777 9 mcg/kg/Day | 0 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| CTCL: E7777 9 mcg/kg/Day | 7 | Not reported | Not reported | Not reported | Not reported |
|---|
Anti-E7777 antibody: Discontinuation/Completion
Analysis denominator · Participants
| Group | Source count |
|---|
| PTCL: E7777 9 mcg/kg/Day | 16 |
|---|
| CTCL: E7777 9 mcg/kg/Day | 18 |
|---|
| Other: E7777 9 mcg/kg/Day | 1 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| PTCL: E7777 9 mcg/kg/Day | 10 | Not reported | Not reported | Not reported | Not reported |
|---|
| CTCL: E7777 9 mcg/kg/Day | 15 | Not reported | Not reported | Not reported | Not reported |
|---|
| Other: E7777 9 mcg/kg/Day | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Anti-IL-2 antibody: Cycle 1 Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| PTCL: E7777 9 mcg/kg/Day | 17 |
|---|
| CTCL: E7777 9 mcg/kg/Day | 19 |
|---|
| Other: E7777 9 mcg/kg/Day | 1 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| PTCL: E7777 9 mcg/kg/Day | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| CTCL: E7777 9 mcg/kg/Day | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Other: E7777 9 mcg/kg/Day | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Anti-IL-2 antibody: Cycle 2 Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| PTCL: E7777 9 mcg/kg/Day | 11 |
|---|
| CTCL: E7777 9 mcg/kg/Day | 14 |
|---|
| Other: E7777 9 mcg/kg/Day | 1 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| PTCL: E7777 9 mcg/kg/Day | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| CTCL: E7777 9 mcg/kg/Day | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
| Other: E7777 9 mcg/kg/Day | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Anti-IL-2 antibody: Cycle 3 Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| PTCL: E7777 9 mcg/kg/Day | 8 |
|---|
| CTCL: E7777 9 mcg/kg/Day | 13 |
|---|
| Other: E7777 9 mcg/kg/Day | 0 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| PTCL: E7777 9 mcg/kg/Day | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| CTCL: E7777 9 mcg/kg/Day | 11 | Not reported | Not reported | Not reported | Not reported |
|---|
Anti-IL-2 antibody: Cycle 5 Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| PTCL: E7777 9 mcg/kg/Day | 4 |
|---|
| CTCL: E7777 9 mcg/kg/Day | 11 |
|---|
| Other: E7777 9 mcg/kg/Day | 0 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| PTCL: E7777 9 mcg/kg/Day | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| CTCL: E7777 9 mcg/kg/Day | 10 | Not reported | Not reported | Not reported | Not reported |
|---|
Anti-IL-2 antibody: Cycle 8 Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| PTCL: E7777 9 mcg/kg/Day | 0 |
|---|
| CTCL: E7777 9 mcg/kg/Day | 7 |
|---|
| Other: E7777 9 mcg/kg/Day | 0 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| CTCL: E7777 9 mcg/kg/Day | 7 | Not reported | Not reported | Not reported | Not reported |
|---|
Anti-IL-2 antibody: Discontinuation/Completion
Analysis denominator · Participants
| Group | Source count |
|---|
| PTCL: E7777 9 mcg/kg/Day | 16 |
|---|
| CTCL: E7777 9 mcg/kg/Day | 18 |
|---|
| Other: E7777 9 mcg/kg/Day | 1 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| PTCL: E7777 9 mcg/kg/Day | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
| CTCL: E7777 9 mcg/kg/Day | 15 | Not reported | Not reported | Not reported | Not reported |
|---|
| Other: E7777 9 mcg/kg/Day | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 11
- group Id
- OG001
- value
- 13
- group Id
- OG002
- value
- 1
- denoms
- counts
- group Id
- OG000
- value
- 17
- group Id
- OG001
- value
- 19
- group Id
- OG002
- value
- 1
- units
- Participants
- title
- Anti-E7777 antibody: Cycle 1 Day 1
- categories
- measurements
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 11
- group Id
- OG002
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 11
- group Id
- OG001
- value
- 14
- group Id
- OG002
- value
- 1
- units
- Participants
- title
- Anti-E7777 antibody: Cycle 2 Day 1
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 11
- denoms
- counts
- group Id
- OG000
- value
- 8
- group Id
- OG001
- value
- 13
- group Id
- OG002
- value
- 0
- units
- Participants
- title
- Anti-E7777 antibody: Cycle 3 Day 1
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 10
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 11
- group Id
- OG002
- value
- 0
- units
- Participants
- title
- Anti-E7777 antibody: Cycle 5 Day 1
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 7
- group Id
- OG002
- value
- 0
- units
- Participants
- title
- Anti-E7777 antibody: Cycle 8 Day 1
- categories
- measurements
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 15
- group Id
- OG002
- value
- 1
- denoms
- counts
- group Id
- OG000
- value
- 16
- group Id
- OG001
- value
- 18
- group Id
- OG002
- value
- 1
- units
- Participants
- title
- Anti-E7777 antibody: Discontinuation/Completion
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 17
- group Id
- OG001
- value
- 19
- group Id
- OG002
- value
- 1
- units
- Participants
- title
- Anti-IL-2 antibody: Cycle 1 Day 1
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 11
- group Id
- OG001
- value
- 14
- group Id
- OG002
- value
- 1
- units
- Participants
- title
- Anti-IL-2 antibody: Cycle 2 Day 1
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 11
- denoms
- counts
- group Id
- OG000
- value
- 8
- group Id
- OG001
- value
- 13
- group Id
- OG002
- value
- 0
- units
- Participants
- title
- Anti-IL-2 antibody: Cycle 3 Day 1
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 10
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 11
- group Id
- OG002
- value
- 0
- units
- Participants
- title
- Anti-IL-2 antibody: Cycle 5 Day 1
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 7
- group Id
- OG002
- value
- 0
- units
- Participants
- title
- Anti-IL-2 antibody: Cycle 8 Day 1
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 15
- group Id
- OG002
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 16
- group Id
- OG001
- value
- 18
- group Id
- OG002
- value
- 1
- units
- Participants
- title
- Anti-IL-2 antibody: Discontinuation/Completion
- denoms
- counts
- group Id
- OG000
- value
- 17
- group Id
- OG001
- value
- 19
- group Id
- OG002
- value
- 1
- units
- Participants
- groups
- description
- Participants with relapsed or refractory PTCL 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: E7777 9 mcg/kg/Day
- description
- Participants with 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
- OG001
- title
- CTCL: E7777 9 mcg/kg/Day
- description
- Participant with extranodal NK/T-cell lymphoma 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
- OG002
- title
- Other: E7777 9 mcg/kg/Day
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- The pharmacodynamics (PD) analysis set was defined as a group of participants who received at least 1 dose of the study drug with at least 1 each of evaluable pre- and post-baseline PD data. Participants who were evaluable for this measure at given time point were included for the assessment.
- reporting Status
- POSTED
- time Frame
- Cycles 1, 2, 3, 5, 8: Day 1 pre-dose; at treatment discontinuation or completion (Cycle 8 Day 21) (each Cycle length = 3 weeks)
- title
- Number of Participants With Positive Anti-E7777 and Anti-IL-2 Antibodies
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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