TriangleNCT03386513 · OUTCOME
DOCR As Assessed by Investigator in Total Frontline BPDCN Participants With CR or CRc
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Up to approximately 81 months
What was measured
DOCR was defined from the first response (CR or CRc) to the time of relapse or death from any cause, whichever comes first. CR was defined as normalization of blast percentage (≤ 5%); normalization of neutrophil count (≥ 1000/μL) and platelet count (≥ 100,000/μL); absence of leukemic blasts; 100% clearance of all skin lesions from baseline; no new lesions in participants without lesions at baseline; nodal masses regression to normal size on CT; and spleen and liver not palpable and nodules disappeared. CRc was defined as normalization of blast percentage (≤ 5%); normalization of neutrophil count (≥ 1000/μL) and platelet count (≥ 100,000/μL); absence of leukemic blasts; marked clearance of all skin lesions from baseline, residual hyperpigmentation or abnormality with BPDCN identified on biopsy (or no biopsy performed); nodal masses regression to normal size on CT; and spleen and liver not palpable and nodules disappeared.
Analysis population: mITT Population included all participants who were eligible based on the screening criteria and who received at least 1 dose of study drug. Here, 'Overall number of participants analyzed' = Total frontline BPDCN participants with CR or CRc. Per protocol, this endpoint evaluated only total frontline BPDCN participants with CR or CRc, all of whom were in arm Schedule A: IMGN632 0.045 mg/kg.
Groups in this outcome
Total Frontline BPDCN Participants - Schedule A: IMGN632 0.045 mg/kg
Participants received IMGN632 via IV infusion on Day 1 of each 21-day cycle.
| Group | Source count |
|---|---|
| Total Frontline BPDCN Participants - Schedule A: IMGN632 0.045 mg/kg | 15 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Total Frontline BPDCN Participants - Schedule A: IMGN632 0.045 mg/kg | 9.76 | Not reported | 4.632 | NA | Data could not be calculated due to insufficient number of events. |
Complete source fields
- classes
- categories
- measurements
- comment
- Data could not be calculated due to insufficient number of events.
- group Id
- OG000
- lower Limit
- 4.632
- upper Limit
- NA
- value
- 9.76
- denoms
- counts
- group Id
- OG000
- value
- 15
- units
- Participants
- description
- DOCR was defined from the first response (CR or CRc) to the time of relapse or death from any cause, whichever comes first. CR was defined as normalization of blast percentage (≤ 5%); normalization of neutrophil count (≥ 1000/μL) and platelet count (≥ 100,000/μL); absence of leukemic blasts; 100% clearance of all skin lesions from baseline; no new lesions in participants without lesions at baseline; nodal masses regression to normal size on CT; and spleen and liver not palpable and nodules disappeared. CRc was defined as normalization of blast percentage (≤ 5%); normalization of neutrophil count (≥ 1000/μL) and platelet count (≥ 100,000/μL); absence of leukemic blasts; marked clearance of all skin lesions from baseline, residual hyperpigmentation or abnormality with BPDCN identified on biopsy (or no biopsy performed); nodal masses regression to normal size on CT; and spleen and liver not palpable and nodules disappeared.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received IMGN632 via IV infusion on Day 1 of each 21-day cycle.
- id
- OG000
- title
- Total Frontline BPDCN Participants - Schedule A: IMGN632 0.045 mg/kg
- param Type
- MEDIAN
- population Description
- mITT Population included all participants who were eligible based on the screening criteria and who received at least 1 dose of study drug. Here, 'Overall number of participants analyzed' = Total frontline BPDCN participants with CR or CRc. Per protocol, this endpoint evaluated only total frontline BPDCN participants with CR or CRc, all of whom were in arm Schedule A: IMGN632 0.045 mg/kg.
- reporting Status
- POSTED
- time Frame
- Up to approximately 81 months
- title
- DOCR As Assessed by Investigator in Total Frontline BPDCN Participants With CR or CRc
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Independent clinical review pending · Not medical advice