TriangleNCT01077544 · OUTCOME
Number of Ph+ CML Participants With Confirmed Complete Hematologic Response (CHR)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- minimum of 12 cycles (28 days per cycle)
What was measured
A confirmed complete hematological response (CHR) is defined when all of the following criteria are achieved at two consecutive assessments, at least 4 weeks apart: white blood cell (WBC) count \< 10 × 109/L; platelet \< 450 × 109/L; basophils \< 5%; no blasts and promyelocytes in peripheral blood (PB); myelocytes + metamyelocytes \< 5% in PB; and no extramedullary involvement. The information used for hematological assessment was to be obtained from the laboratory and extramedullary data, all merged by patient and date.
Analysis population: Full analysis set (FAS): consists of all patients who passed the screening and are enrolled into the study. Patients may or may not have taken study drug.
Groups in this outcome
Group 1
1 year to \< 10 years pediatric patients
Group 2
\>= 10 years to \<18 years pediatric patients
| Group | Source count |
|---|---|
| Group 1 | 5 |
| Group 2 | 6 |
Reported measurements
Yes
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Group 1 | 5 | Not reported | Not reported | Not reported | Not reported |
| Group 2 | 5 | Not reported | Not reported | Not reported | Not reported |
No
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Group 1 | 0 | Not reported | Not reported | Not reported | Not reported |
| Group 2 | 1 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 5
- title
- Yes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- title
- No
- denoms
- counts
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 6
- units
- Participants
- description
- A confirmed complete hematological response (CHR) is defined when all of the following criteria are achieved at two consecutive assessments, at least 4 weeks apart: white blood cell (WBC) count \< 10 × 109/L; platelet \< 450 × 109/L; basophils \< 5%; no blasts and promyelocytes in peripheral blood (PB); myelocytes + metamyelocytes \< 5% in PB; and no extramedullary involvement. The information used for hematological assessment was to be obtained from the laboratory and extramedullary data, all merged by patient and date.
- groups
- description
- 1 year to \< 10 years pediatric patients
- id
- OG000
- title
- Group 1
- description
- \>= 10 years to \<18 years pediatric patients
- id
- OG001
- title
- Group 2
- param Type
- NUMBER
- population Description
- Full analysis set (FAS): consists of all patients who passed the screening and are enrolled into the study. Patients may or may not have taken study drug.
- reporting Status
- POSTED
- time Frame
- minimum of 12 cycles (28 days per cycle)
- title
- Number of Ph+ CML Participants With Confirmed Complete Hematologic Response (CHR)
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice