TriangleNCT00109707 · OUTCOME
Number of Participants With Complete Hematologic Response (Phase II)
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
- Up to End of the Treatment (Approximately 7.5 years)
What was measured
A Complete Hematologic Response (CHR) is obtained when all the following criteria are met: WBC ≤ institutional ULN; platelets ≤ 450,000/mm3; ≤20% basophils in peripheral blood; no blasts or promyelocytes in PB cells; \< 5% myelocytes plus metamyelocytes in PB cells; no extra-medullary involvement including no hepatomegaly or splenomegaly.
Analysis population: Full Analysis Set (FAS): All participants who received at least one dose of study medication
Groups in this outcome
CML-CP With Prior Imatinib Only
Adult participants PH+ CML-CP without prior TKI treatment with either resistant / intolerant to Imatinib received 400 mg Nilotinib orally twice daily up to the end of treatment (September-2012).
CML-AP With Prior Imatinib Only
Adult participants Ph+ CML-AP without prior TKI treatment with either resistant / intolerant to Imatinib received 400 mg Nilotinib orally twice daily up to the end of treatment (September-2012).
CML-CP
Adult participants Ph+ CML-CP in addition to prior TKI treatment with either resistant / intolerant to Imatinib received 400 mg Nilotinib orally twice daily up to the end of treatment (September-2012).
| Group | Source count |
|---|---|
| CML-CP With Prior Imatinib Only | 321 |
| CML-AP With Prior Imatinib Only | 137 |
| CML-CP | 35 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| CML-CP With Prior Imatinib Only | 158 | Not reported | Not reported | Not reported | Not reported |
| CML-AP With Prior Imatinib Only | 76 | Not reported | Not reported | Not reported | Not reported |
| CML-CP | 27 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 158
- group Id
- OG001
- value
- 76
- group Id
- OG002
- value
- 27
- denoms
- counts
- group Id
- OG000
- value
- 321
- group Id
- OG001
- value
- 137
- group Id
- OG002
- value
- 35
- units
- Participants
- description
- A Complete Hematologic Response (CHR) is obtained when all the following criteria are met: WBC ≤ institutional ULN; platelets ≤ 450,000/mm3; ≤20% basophils in peripheral blood; no blasts or promyelocytes in PB cells; \< 5% myelocytes plus metamyelocytes in PB cells; no extra-medullary involvement including no hepatomegaly or splenomegaly.
- groups
- description
- Adult participants PH+ CML-CP without prior TKI treatment with either resistant / intolerant to Imatinib received 400 mg Nilotinib orally twice daily up to the end of treatment (September-2012).
- id
- OG000
- title
- CML-CP With Prior Imatinib Only
- description
- Adult participants Ph+ CML-AP without prior TKI treatment with either resistant / intolerant to Imatinib received 400 mg Nilotinib orally twice daily up to the end of treatment (September-2012).
- id
- OG001
- title
- CML-AP With Prior Imatinib Only
- description
- Adult participants Ph+ CML-CP in addition to prior TKI treatment with either resistant / intolerant to Imatinib received 400 mg Nilotinib orally twice daily up to the end of treatment (September-2012).
- id
- OG002
- title
- CML-CP
- param Type
- NUMBER
- population Description
- Full Analysis Set (FAS): All participants who received at least one dose of study medication
- reporting Status
- POSTED
- time Frame
- Up to End of the Treatment (Approximately 7.5 years)
- title
- Number of Participants With Complete Hematologic Response (Phase II)
- type
- SECONDARY
- unit Of Measure
- participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice