TriangleNCT01077544 · OUTCOME
Number of Ph+ CML Participants With Cytogenic Response
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
Cytogenetic response was initially assessed as the percentage of Ph+ metaphases in the bone marrow (BM) and performed within 21 days prior to study entry. A major cytogenetic response (0% to 35% Ph+ metaphases test positive for the Philadelphia chromosome) combines both complete cytogenetic (CCyR) and partial cytogenetic response (PCyR). CCyR implies 0% Ph+ metaphases in the BM, PCyR is \> 0% to 35%, minor cytogenetic response (mCyR) is \> 35% to 65%, minimal response is \> 65% to 95% and no response is \> 95% Ph+ metaphases in the BM.
Analysis population: FAS consist of all patients (pts) who passed screening \& are enrolled into study. Patients may or may not have taken study drug. One (1) Ph+ CML patient in Group 2 was Ph+ at baseline \& discontinued study prior to subsequent cytogenetic assessment. This pt doesn't appear in any cytogenic response category.
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
Complete cytogenic response (CCyR)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Group 1 | 2 | Not reported | Not reported | Not reported | Not reported |
| Group 2 | 2 | Not reported | Not reported | Not reported | Not reported |
Partial cytogenic response (PCyR)
| 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 |
Minor cytogenic response (mCyR)
| 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 |
Minimal
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Group 1 | 0 | Not reported | Not reported | Not reported | Not reported |
| Group 2 | 0 | Not reported | Not reported | Not reported | Not reported |
None
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Group 1 | 0 | Not reported | Not reported | Not reported | Not reported |
| Group 2 | 0 | Not reported | Not reported | Not reported | Not reported |
Absence of Ph+ at baseline
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Group 1 | 3 | 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
- 2
- group Id
- OG001
- value
- 2
- title
- Complete cytogenic response (CCyR)
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- title
- Partial cytogenic response (PCyR)
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- title
- Minor cytogenic response (mCyR)
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- Minimal
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- None
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 1
- title
- Absence of Ph+ at baseline
- denoms
- counts
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 6
- units
- Participants
- description
- Cytogenetic response was initially assessed as the percentage of Ph+ metaphases in the bone marrow (BM) and performed within 21 days prior to study entry. A major cytogenetic response (0% to 35% Ph+ metaphases test positive for the Philadelphia chromosome) combines both complete cytogenetic (CCyR) and partial cytogenetic response (PCyR). CCyR implies 0% Ph+ metaphases in the BM, PCyR is \> 0% to 35%, minor cytogenetic response (mCyR) is \> 35% to 65%, minimal response is \> 65% to 95% and no response is \> 95% Ph+ metaphases in the BM.
- 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
- FAS consist of all patients (pts) who passed screening \& are enrolled into study. Patients may or may not have taken study drug. One (1) Ph+ CML patient in Group 2 was Ph+ at baseline \& discontinued study prior to subsequent cytogenetic assessment. This pt doesn't appear in any cytogenic response category.
- reporting Status
- POSTED
- time Frame
- minimum of 12 cycles (28 days per cycle)
- title
- Number of Ph+ CML Participants With Cytogenic Response
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice