NCT01844765 · OUTCOME
MMR Rate by Time Points in Newly Diagnosed Ph+ CML-CP Patients
Open Label, Phase II Study to Evaluate Efficacy and Safety of Oral Nilotinib in Philadelphia Positive (Ph+) Chronic Myelogenous Leukemia (CML) Pediatric Patients. · Source last updated 2021-04-22
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- by 3, 6, 9, 12, 24, 36, 48, 66 cycles (1 cycle = 28 days)
What was measured
Major molecular response (MMR) was defined as BCR-ABL/ABL % ≤ 0.1% by IS as measured by RQ-PCR, confirmed by duplicate analysis of the same sample.
Analysis population: Full Analysis Set (FAS): All patients who received at least one dose of study medication
Groups in this outcome
Newly Diagnosed and Untreated Ph+ CML in First CP
Patients newly diagnosed in Chronic phase. Diagnosis within 6 months of date of first cytogenetic analysis confirming Philadelphia chromosome with (9;22) translocation by standard conventional cytogenetic analysis.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Newly Diagnosed and Untreated Ph+ CML in First CP | 25 |
|---|
Reported measurements
By cycle 3
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Newly Diagnosed and Untreated Ph+ CML in First CP | 12.0 | Not reported | 2.5 | 31.2 | Not reported |
|---|
By cycle 6
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Newly Diagnosed and Untreated Ph+ CML in First CP | 52.0 | Not reported | 31.3 | 72.2 | Not reported |
|---|
By cycle 9
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Newly Diagnosed and Untreated Ph+ CML in First CP | 56.0 | Not reported | 34.9 | 75.6 | Not reported |
|---|
By cycle 12
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Newly Diagnosed and Untreated Ph+ CML in First CP | 64.0 | Not reported | 42.5 | 82.0 | Not reported |
|---|
By cycle 18
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Newly Diagnosed and Untreated Ph+ CML in First CP | 68.0 | Not reported | 46.5 | 85.1 | Not reported |
|---|
By cycle 24
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Newly Diagnosed and Untreated Ph+ CML in First CP | 68.0 | Not reported | 46.5 | 85.1 | Not reported |
|---|
By cycle 36
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Newly Diagnosed and Untreated Ph+ CML in First CP | 76.0 | Not reported | 54.9 | 90.6 | Not reported |
|---|
By cycle 48
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Newly Diagnosed and Untreated Ph+ CML in First CP | 76.0 | Not reported | 54.9 | 90.6 | Not reported |
|---|
By cycle 66
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Newly Diagnosed and Untreated Ph+ CML in First CP | 76.0 | Not reported | 54.9 | 90.6 | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2.5
- upper Limit
- 31.2
- value
- 12.0
- title
- By cycle 3
- categories
- measurements
- group Id
- OG000
- lower Limit
- 31.3
- upper Limit
- 72.2
- value
- 52.0
- title
- By cycle 6
- categories
- measurements
- group Id
- OG000
- lower Limit
- 34.9
- upper Limit
- 75.6
- value
- 56.0
- title
- By cycle 9
- categories
- measurements
- group Id
- OG000
- lower Limit
- 42.5
- upper Limit
- 82.0
- value
- 64.0
- title
- By cycle 12
- categories
- measurements
- group Id
- OG000
- lower Limit
- 46.5
- upper Limit
- 85.1
- value
- 68.0
- title
- By cycle 18
- categories
- measurements
- group Id
- OG000
- lower Limit
- 46.5
- upper Limit
- 85.1
- value
- 68.0
- title
- By cycle 24
- categories
- measurements
- group Id
- OG000
- lower Limit
- 54.9
- upper Limit
- 90.6
- value
- 76.0
- title
- By cycle 36
- categories
- measurements
- group Id
- OG000
- lower Limit
- 54.9
- upper Limit
- 90.6
- value
- 76.0
- title
- By cycle 48
- categories
- measurements
- group Id
- OG000
- lower Limit
- 54.9
- upper Limit
- 90.6
- value
- 76.0
- title
- By cycle 66
- description
- Major molecular response (MMR) was defined as BCR-ABL/ABL % ≤ 0.1% by IS as measured by RQ-PCR, confirmed by duplicate analysis of the same sample.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Patients newly diagnosed in Chronic phase. Diagnosis within 6 months of date of first cytogenetic analysis confirming Philadelphia chromosome with (9;22) translocation by standard conventional cytogenetic analysis.
- id
- OG000
- title
- Newly Diagnosed and Untreated Ph+ CML in First CP
- param Type
- NUMBER
- population Description
- Full Analysis Set (FAS): All patients who received at least one dose of study medication
- reporting Status
- POSTED
- time Frame
- by 3, 6, 9, 12, 24, 36, 48, 66 cycles (1 cycle = 28 days)
- title
- MMR Rate by Time Points in Newly Diagnosed Ph+ CML-CP Patients
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
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