TriangleNCT02113982 · OUTCOME
ORR in First-line BPDCN, R/R BPDCN and AML
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of evaluable patients
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- at pre-defined treatment cycle intervals from randomization up to disease progression, up to 5 years
What was measured
Objective response rate (ORR) defines as the percentage of patients who achieved CR (CR+CRc), CR with incomplete blood count recovery (CRi), or partial response (PR) after treatment with Tagraxofusp according to the previously reported definitions of CR, CRc and the following one of CRi and PR: CRi: CR with incomplete of neutrophil and/or platelet count and absence of leukemic blast in the peripheral blood Marrow: PR defined as decrease by ≥50% in blast percentage to 5-25% Peripheral blood: PR defined as normalization of neutrophil count (≥ 1,000/µL) and platelet count (≥ 100,000/µL) Skin: 50%-\<100% clearance of all skis lesions from baseline; no new lesions in patients without lesions at baseline Nodal masses: ≥50% decrease in SPD of up to 6 largest dominant masses; no increase in size of other nodes Spleen, liver: ≥50% in SPD of nodules (for single nodule in greatest transverse diameter); no increase in size of liver or spleen
Analysis population: Efficacy population including evaluable patients treated at 12 μg/kg/day in the first-line BPDCN, R/R BPDCN and AML
Groups in this outcome
First-line BPDCN
First-line BPDCN patients enrolled across stages
R/R BPDCN
R/R BPDCN patients enrolled across stages
Acute Myeloid Leukemia
AML patients enrolled in stages 1 and 2
| Group | Source count |
|---|---|
| First-line BPDCN | 65 |
| R/R BPDCN | 19 |
| Acute Myeloid Leukemia | 36 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| First-line BPDCN | 75.4 | Not reported | 63.1 | 85.2 | Not reported |
| R/R BPDCN | 57.9 | Not reported | 33.5 | 79.7 | Not reported |
| Acute Myeloid Leukemia | 3 | Not reported | 0.1 | 14.2 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 63.1
- upper Limit
- 85.2
- value
- 75.4
- group Id
- OG001
- lower Limit
- 33.5
- upper Limit
- 79.7
- value
- 57.9
- group Id
- OG002
- lower Limit
- 0.1
- upper Limit
- 14.2
- value
- 3
- denoms
- counts
- group Id
- OG000
- value
- 65
- group Id
- OG001
- value
- 19
- group Id
- OG002
- value
- 36
- units
- Participants
- description
- Objective response rate (ORR) defines as the percentage of patients who achieved CR (CR+CRc), CR with incomplete blood count recovery (CRi), or partial response (PR) after treatment with Tagraxofusp according to the previously reported definitions of CR, CRc and the following one of CRi and PR: CRi: CR with incomplete of neutrophil and/or platelet count and absence of leukemic blast in the peripheral blood Marrow: PR defined as decrease by ≥50% in blast percentage to 5-25% Peripheral blood: PR defined as normalization of neutrophil count (≥ 1,000/µL) and platelet count (≥ 100,000/µL) Skin: 50%-\<100% clearance of all skis lesions from baseline; no new lesions in patients without lesions at baseline Nodal masses: ≥50% decrease in SPD of up to 6 largest dominant masses; no increase in size of other nodes Spleen, liver: ≥50% in SPD of nodules (for single nodule in greatest transverse diameter); no increase in size of liver or spleen
- dispersion Type
- 95% Confidence Interval
- groups
- description
- First-line BPDCN patients enrolled across stages
- id
- OG000
- title
- First-line BPDCN
- description
- R/R BPDCN patients enrolled across stages
- id
- OG001
- title
- R/R BPDCN
- description
- AML patients enrolled in stages 1 and 2
- id
- OG002
- title
- Acute Myeloid Leukemia
- param Type
- NUMBER
- population Description
- Efficacy population including evaluable patients treated at 12 μg/kg/day in the first-line BPDCN, R/R BPDCN and AML
- reporting Status
- POSTED
- time Frame
- at pre-defined treatment cycle intervals from randomization up to disease progression, up to 5 years
- title
- ORR in First-line BPDCN, R/R BPDCN and AML
- type
- SECONDARY
- unit Of Measure
- percentage of evaluable patients
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice