Comparison · NCT01121393-sae
Afatinib 40 Milligram (mg) vs Gemcitabine / 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
Cite this record
ConductScience Library. Afatinib 40 Milligram (mg) vs Gemcitabine / Cisplatin Chemotherapy: serious adverse events. Trial comparisons, record NCT01121393-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01121393-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 | 0.167 | 0.125 | 0.22 | wilson | |
| Risk in group 2 | 0.106 | 0.0618 | 0.176 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0612 | -0.0207 | 0.13 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.58 | 0.861 | 2.89 | log | |
| Odds ratio, group 1 over group 2 | 1.69 | 0.85 | 3.37 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Afatinib 40 Milligram (mg) than on Gemcitabine / Cisplatin Chemotherapy | 16.3 | 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 | Afatinib 40 Milligram (mg) | Patients received Afatinib film-coated tablets 40 mg once daily (q.d.) orally with possible dose escalation to 50 mg q.d. and dose reduction to 40 mg q.d. (if applicable), 30 mg q.d., or 20 mg q.d. (according to the protocol-defined dose-escalation and dose-reduction scheme), if required. No dose increase was allowed after dose reduction. Each treatment course was planned to be 21 days. For afatinib, patients received continuous daily dosing until disease progression, unacceptable adverse events (AEs) occurred, or withdrawal of consent for any reason. | 40 | 239 | EG000 |
| Group 2 | Gemcitabine / Cisplatin Chemotherapy | Patients received Gemcitabine (lyophilised powder) 1000 milligram per square metre (mg/m²) as an intravenous infusion over 30 minutes on day 1 and day 8, cisplatin (solution for infusion) 75 mg/m² as an intravenous infusion on Day 1 of each 21-day treatment course up to 6 cycles; Chemotherapy could be delayed or the dose could be reduced in accordance with the guidance in the current summary of product characteristics. For gemcitabine / cisplatin, patients were to receive a maximum of 6 treatment courses unless they developed disease progression, experienced unacceptable AEs, or withdrawal of consent for any reason. | 12 | 113 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From first administration of study medication until 28 days after the last administration of study medication up to 374 weeks
Source ClinicalTrials.gov
Trial
- Title
- BIBW 2992 (Afatinib) vs Gemcitabine-cisplatin in 1st Line Non-small Cell Lung Cancer (NSCLC)
- NCT number
- NCT01121393
- Phases
- PHASE3
- Conditions
- Carcinoma, Non-Small-Cell Lung, Adenocarcinoma
- Interventions
- Gemcitabine+Cisplatin, BIBW 2992
- Lead sponsor
- Boehringer Ingelheim
- Results first posted
- 2015-01-26
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01121393?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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