TriangleNCT02953652 · OUTCOME
Objective Response Rate by Disease Subtype
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
- Up to approximately 47 months.
What was measured
Tumor assessment was performed every 8 weeks until disease progression. Objective response rate was defined as the percentage of patients who achieved a CR or a PR according to IWC 2014 criteria and assessed by an IOERC. CR: Target nodes/nodal masses must regress to \<1.5 cm in LDi, no extralymphatic sites of disease, nonmeasured lesion is absent, disappearance of spleen or liver enlargement, no new lesions, no BM involvement. PR: ≥50% decrease in SPD of up to 6 target measurable nodes and extranodal sites, nonmeasured lesions is absent/normal, regressed, but no increase, spleen must have regressed by \>50% in length beyond normal, no new lesions. Disease subtype (PTCL-NOS, AITL, ALCL, ALK, EATL) was assessed by Central Pathology Review (CPR).
Analysis population: PPS \[Per Protocol Set\]
Groups in this outcome
PTCL-NOS
PTCL Not Otherwise Specified
AITL
Angioimmunoblastic T-cell lymphoma
ALCL, ALK-
Anaplastic Large-cell Lymphoma, ALK-
EATL
Enteropathy-associated T-cell lymphoma
| Group | Source count |
|---|---|
| PTCL-NOS | 34 |
| AITL | 8 |
| ALCL, ALK- | 3 |
| EATL | 1 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| PTCL-NOS | 12 | Not reported | Not reported | Not reported | Not reported |
| AITL | 7 | Not reported | Not reported | Not reported | Not reported |
| ALCL, ALK- | 1 | Not reported | Not reported | Not reported | Not reported |
| EATL | 1 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 12
- group Id
- OG001
- value
- 7
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 1
- denoms
- counts
- group Id
- OG000
- value
- 34
- group Id
- OG001
- value
- 8
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 1
- units
- Participants
- description
- Tumor assessment was performed every 8 weeks until disease progression. Objective response rate was defined as the percentage of patients who achieved a CR or a PR according to IWC 2014 criteria and assessed by an IOERC. CR: Target nodes/nodal masses must regress to \<1.5 cm in LDi, no extralymphatic sites of disease, nonmeasured lesion is absent, disappearance of spleen or liver enlargement, no new lesions, no BM involvement. PR: ≥50% decrease in SPD of up to 6 target measurable nodes and extranodal sites, nonmeasured lesions is absent/normal, regressed, but no increase, spleen must have regressed by \>50% in length beyond normal, no new lesions. Disease subtype (PTCL-NOS, AITL, ALCL, ALK, EATL) was assessed by Central Pathology Review (CPR).
- groups
- description
- PTCL Not Otherwise Specified
- id
- OG000
- title
- PTCL-NOS
- description
- Angioimmunoblastic T-cell lymphoma
- id
- OG001
- title
- AITL
- description
- Anaplastic Large-cell Lymphoma, ALK-
- id
- OG002
- title
- ALCL, ALK-
- description
- Enteropathy-associated T-cell lymphoma
- id
- OG003
- title
- EATL
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- PPS \[Per Protocol Set\]
- reporting Status
- POSTED
- time Frame
- Up to approximately 47 months.
- title
- Objective Response Rate by Disease Subtype
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice