Comparison · NCT03572634-sae
TP-0903 Monotherapy (25mg Dose of TP-0903) vs TP-0903 and Ibrutinib Combination Therapy (20 mg Dose of TP-0903): serious adverse events
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. TP-0903 Monotherapy (25mg Dose of TP-0903) vs TP-0903 and Ibrutinib Combination Therapy (20 mg Dose of TP-0903): serious adverse events. Trial comparisons, record NCT03572634-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03572634-sae
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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 | 0.793 | wilson | |
| Risk in group 2 | 1 | 0.342 | 1 | wilson | |
| Risk difference, group 1 minus group 2 | -1 | -1 | 0.0305 | 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, for one fewer participant with a serious adverse event on TP-0903 Monotherapy (25mg Dose of TP-0903) than on TP-0903 and Ibrutinib Combination Therapy (20 mg Dose of TP-0903) | 1 | from the risk difference interval | the interval includes no difference |
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 | TP-0903 Monotherapy (25mg Dose of TP-0903) | Patients who are intolerant to, or have had progressive disease on B-cell receptor antagonists and/or BCL-2 antagonists or other investigational treatments. This represents phase I, phase II never occurred and dose escalation did not occur. | 0 | 1 | EG000 |
| Group 2 | TP-0903 and Ibrutinib Combination Therapy (20 mg Dose of TP-0903) | Patients who have progression of disease on ibrutinib and the treating provider considers continuation of ibrutinib therapy to be in the best interest of the patient. This represents phase I, phase II never occurred and dose escalation did not occur. | 2 | 2 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Treatment-emergent adverse events (TEAEs) were defined as all AEs that begin on or after the date of first dose of study drug. All patients in the study participated in Phase 1; a 30 day follow-up visit as part of the protocol noted patients undergo a safety evaluation in which the patient's condition during the 30 days after the last dose of study drug can be assessed. There is a visit window of up to 14 days after completion of 30 days from the last dose (ie, within 45 days after last dose).
Source ClinicalTrials.gov
Trial
- Title
- Phase 1/2 Study of TP-0903 (an Inhibitor of AXL Kinase) in Patients With Previously Treated CLL
- NCT number
- NCT03572634
- Phases
- PHASE1, PHASE2
- Conditions
- Chronic Lymphocytic Leukemia, CLL, SLL, Small Lymphocytic Lymphoma
- Interventions
- TP-0903, TP-0903 and ibrutinib combination therapy
- Lead sponsor
- Sumitomo Pharma America, Inc.
- Results first posted
- 2021-02-02
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03572634?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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