Comparison · NCT03296163-sae
MB02 (Bevacizumab Biosimilar Drug) vs EU-approved Avastin®: 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. MB02 (Bevacizumab Biosimilar Drug) vs EU-approved Avastin®: serious adverse events. Trial comparisons, record NCT03296163-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03296163-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 | 0.186 | 0.147 | 0.234 | wilson | |
| Risk in group 2 | 0.174 | 0.136 | 0.22 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0123 | -0.0484 | 0.0729 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.07 | 0.765 | 1.5 | log | |
| Odds ratio, group 1 over group 2 | 1.09 | 0.722 | 1.64 | log | |
| Number needed to harm, for one more participant with a serious adverse event on MB02 (Bevacizumab Biosimilar Drug) than on EU-approved Avastin® | 81.3 | 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 | MB02 (Bevacizumab Biosimilar Drug) | MB02 (Bevacizumab Biosimilar Drug) + Carboplatin/Paclitaxel~MB02 (Bevacizumab Biosimilar Drug): 15 mg/kg IV every 3 weeks on Day 1~Carboplatin: Carboplatin AUC 6 IV every 3 weeks on Day 1 for 6 cycles~Paclitaxel: Paclitaxel 200 mg/m2 IV every 3 weeks on Day 1 for 6 cycles | 58 | 311 | EG000 |
| Group 2 | EU-approved Avastin® | EU-approved Avastin® + Carboplatin/Paclitaxel~EU-approved Avastin®: 15 mg/kg IV every 3 weeks on Day 1~Carboplatin: Carboplatin AUC 6 IV every 3 weeks on Day 1 for 6 cycles~Paclitaxel: Paclitaxel 200 mg/m2 IV every 3 weeks on Day 1 for 6 cycles | 54 | 310 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Throughout the study completion. An average of two years (from the beginning of the study at 06-February-2018 till last patient last visit in 27-February-2020).
Source ClinicalTrials.gov
Trial
- Title
- A Study Comparing MB02 and Avastin® in Subjects With Stage IIIB/IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
- NCT number
- NCT03296163
- Phases
- PHASE3
- Conditions
- Non-small Cell Lung Cancer
- Interventions
- MB02 (Bevacizumab Biosimilar Drug), EU-approved Avastin®, Carboplatin, Paclitaxel
- Lead sponsor
- mAbxience Research S.L.
- Results first posted
- 2021-03-26
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03296163?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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