Comparison · NCT00949650-sae
Afatinib 40 mg vs Pemetrexed/Cisplatin Chemotherapy: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Afatinib 40 mg vs Pemetrexed/Cisplatin Chemotherapy: serious adverse events. Trial comparisons, record NCT00949650-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00949650-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 | 0.314 | 0.258 | 0.377 | wilson | |
| Risk in group 2 | 0.225 | 0.157 | 0.311 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0892 | -0.0139 | 0.182 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.4 | 0.941 | 2.07 | log | |
| Odds ratio, group 1 over group 2 | 1.58 | 0.933 | 2.67 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Afatinib 40 mg than on Pemetrexed/Cisplatin Chemotherapy | 11.2 | 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 | Afatinib 40 mg | Patients received Afatinib monotherapy 40 mg film-coated tablets orally once daily. | 72 | 229 | EG000 |
| Group 2 | Pemetrexed/Cisplatin Chemotherapy | Patients received Pemetrexed 500 mg/m\^2 lyophilised powder as intravenous infusion after Cisplatin 75 mg/m\^2 solution for infusion as intravenous infusion on Day 1 of each 21-day treatment course up to 6 cycles. | 25 | 111 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- First administration of trial medication until 28 days after last administration of trial medication.
Source ClinicalTrials.gov
Trial
- Title
- BIBW 2992 (Afatinib) Versus Chemotherapy as First Line Treatment in NSCLC With EGFR Mutation
- NCT number
- NCT00949650
- Phases
- PHASE3
- Conditions
- Carcinoma, Non-Small-Cell Lung, Adenocarcinoma
- Interventions
- Pemetrexed, BIBW 2992, Cisplatin
- Lead sponsor
- Boehringer Ingelheim
- Results first posted
- 2013-11-19
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00949650?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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