Comparison · NCT02759016-1ee5208d
Dose Cohort BI 836826 100 Milligram (mg) + Ibrutinib vs Dose Cohort BI 836826 200 Milligram (mg) + Ibrutinib: Number of Participants With Dose Limiting Toxicities (DLTs) During the First Treatment Cycle
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
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ConductScience Library. Dose Cohort BI 836826 100 Milligram (mg) + Ibrutinib vs Dose Cohort BI 836826 200 Milligram (mg) + Ibrutinib: Number of Participants With Dose Limiting Toxicities (DLTs) During the First Treatment Cycle. Trial comparisons, record NCT02759016-1ee5208d. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02759016-1ee5208d
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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 | 0.0000000000000000555 | 0.561 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.561 | 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 | Dose Cohort BI 836826 100 Milligram (mg) + Ibrutinib | Participants underwent a 2-week run-in phase with ibrutinib prior to the start of BI 836826. In combination with ibrutinib (420 mg daily dose, orally administered) BI 836826 was administered intravenously as a rate controlled injection in 4-week cycles, every two weeks for the first 16 weeks (Cycles 1-4), and every 4 weeks starting at week 17 (Cycle 5) until week 48 (Cycle 12). BI 836826 was administered in Cycle 1 on day 1 (10 mg), days 2 and 8 (50% of the assigned dose on each day), day 15 (100% of the assigned dose), in Cycles 2-4 on days 1 and 15 of each cycle (100% of the assigned dose), in Cycles 5-12 on day 1 (100% of the assigned dose). Participants could have initiated 12 cycles with BI 836826 and could be treated with ibrutinib unless progression, unacceptable toxicity, or withdrawal of consent occurred earlier. Continued treatment beyond Cycle 12 (up to a maximum of 24 treatment cycles) was possible for participants with a pre-specified response status at end of Cycle 12. | 0 | 3 | OG000 |
| Group 2 | Dose Cohort BI 836826 200 Milligram (mg) + Ibrutinib | Participants underwent a 2-week run-in phase with ibrutinib prior to the start of BI 836826. In combination with ibrutinib (420 mg daily dose, orally administered) BI 836826 was administered intravenously as a rate controlled injection in 4-week cycles, every two weeks for the first 16 weeks (Cycles 1-4), and every 4 weeks starting at week 17 (Cycle 5) until week 48 (Cycle 12). BI 836826 was administered in Cycle 1 on day 1 (10 mg), days 2 and 8 (50% of the assigned dose on each day), day 15 (100% of the assigned dose), in Cycles 2-4 on days 1 and 15 of each cycle (100% of the assigned dose), in Cycles 5-12 on day 1 (100% of the assigned dose). Participants could have initiated 12 cycles with BI 836826 and could be treated with ibrutinib unless progression, unacceptable toxicity, or withdrawal of consent occurred earlier. Continued treatment beyond Cycle 12 (up to a maximum of 24 treatment cycles) was possible for participants with a pre-specified response status at end of Cycle 12. | 0 | 3 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Participants With Dose Limiting Toxicities (DLTs) During the First Treatment Cycle
- Description
Number of participants with Dose Limiting Toxicities (DLTs) during the first treatment cycle. DLT was defined as any non-hematologic adverse event (AE) of Grade ≥ 3 related to BI 836826 and/or ibrutinib except infusion-related reaction (any Grade), Grade 3 Aspartate Aminotransferase (AST)- and/or Alanine Aminotransferase (ALT) elevation without concomitant bilirubin, elevation or any other asymptomatic Grade 3 laboratory abnormality with spontaneous recovery within 1 week. The following hematologic AEs related to BI 836826 and/or ibrutinib were considered DLT: Grade 4 neutropenia with concomitant infection, Grade 4 febrile neutropenia, and Grade 3 febrile neutropenia not resolving within 72 hours with appropriate treatment (antibiotics, antivirals, antifungals, growth factor support), Grade 4 thrombocytopenia with clinically significant bleeding, Grade 4 anemia, any Grade 5 hematologic AE.
- Time frame
- First treatment cycle, 4 weeks from first administration of BI 836826.
- Population
- All participants who were documented to have initiated at least one dose of BI 836826 and were not replaced for the Maximum Tolerated Dose (MTD) evaluation.
Source ClinicalTrials.gov
Trial
- Title
Intravenous BI 836826 in Combination With Ibrutinib in Relapsed/Refractory CLL Patients Who Have Been Pre-treated With at Least One Prior Line of Systemic Therapy, and Who Are Eligible for Treatment With Ibrutinib
- NCT number
- NCT02759016
- Phases
- PHASE1
- Conditions
- Leukemia, Lymphocytic, Chronic, B-Cell
- Interventions
- BI 836826, Ibrutinib
- Lead sponsor
- Boehringer Ingelheim
- Results first posted
- 2020-07-24
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02759016?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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