Comparison · NCT02415608-574d7280
Ibrutinib 420 mg/Day vs Ibrutinib 560 mg/Day: Overall Response Rate (ORR)
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Ibrutinib 420 mg/Day vs Ibrutinib 560 mg/Day: Overall Response Rate (ORR). Trial comparisons, record NCT02415608-574d7280. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02415608-574d7280
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0 | 0.0000000000000000555 | 0.561 | wilson | |
| Risk in group 2 | 0 | 0 | 0.793 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.793 | 0.561 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to treat | from the risk difference interval | the two groups' risks are equal |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Ibrutinib 420 mg/Day | Participants receive ibrutinib daily on days 1 to 28, at 420 mg/day in 28-day cycles~Ibrutinib: Given orally | 0 | 3 | OG000 |
| Group 2 | Ibrutinib 560 mg/Day | Participants receive ibrutinib daily on days 1 to 28, at 560 mg/day in 28-day cycles~Ibrutinib: Given orally | 0 | 1 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Overall Response Rate (ORR)
- Description
Overall response rate (ORR) is reported as the sum of the rates of participants achieving complete remission (CR), partial remission (PR), \& clinical improvement (CI). A clinical response is a response with duration of ≥ 12 weeks.~CR is defined as all 4 criteria:~* No presence of compact neoplastic mast cell aggregates~* Serum tryptase level \< 20 ng/mL~* Peripheral blood count remission defined as absolute neutrophil count (ANC) ≥1 x 10e9/L + normal differential, Hb ≥11 g/dL, \& platelet count ≥100x10e9/L~* Complete resolution of palpable hepatosplenomegaly \& all biopsy-proven or suspected SM-related organ damage~PR is defined as all 3 criteria with response duration ≥12 weeks, that is not CR or progressive disease:~* ≥ 50% reduction in neoplastic mast cells~* Serum tryptase level reduced ≥50%~* Resolution of 1+ biopsy-proven or suspected systemic mastocytosis (SM)-related organ damage findings~CI is defined as any improvement in any of the above measures.
- Time frame
- Up to 6 months
- Population
Source ClinicalTrials.gov
Trial
- Title
- Ibrutinib in Treating Patients With Advanced Systemic Mastocytosis
- NCT number
- NCT02415608
- Phases
- PHASE2
- Conditions
- Aggressive Systemic Mastocytosis, Mast Cell Leukemia, Systemic Mastocytosis
- Interventions
- Ibrutinib
- Lead sponsor
- Jason Robert Gotlib
- Results first posted
- 2018-09-20
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02415608?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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