Comparison · NCT00818441-sae
Dacomitinib: Cohort A vs Dacomitinib: Cohort B: 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. Dacomitinib: Cohort A vs Dacomitinib: Cohort B: serious adverse events. Trial comparisons, record NCT00818441-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00818441-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 | 0.326 | 0.237 | 0.429 | wilson | |
| Risk in group 2 | 0.3 | 0.167 | 0.479 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0258 | -0.174 | 0.194 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.09 | 0.583 | 2.03 | log | |
| Odds ratio, group 1 over group 2 | 1.13 | 0.459 | 2.77 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Dacomitinib: Cohort A than on Dacomitinib: Cohort B | 38.7 | 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 | Dacomitinib: Cohort A | Participants who had adenocarcinoma of lung, had not received prior systemic therapy and were either nonsmokers, former light smokers or were known to have an epidermal growth factor receptor (EGFR)-activating mutation, received dacomitinib 45 milligram (mg) or 30 mg tablet orally daily in cycles of 28 days until progression of disease, unacceptable toxicity, or participant withdrawal. Dose escalated to 45 mg in participants after at least 8 weeks of therapy who had started treatment at 30 mg and were tolerating treatment for at least 4 consecutive weeks as per investigator's judgment. Dose modifications for treatment-related toxicity were allowed for up to 2 dose reductions (to 30 mg and then to 15 mg) if the participant started at 45 mg. Dose interruption for treatment-related toxicity was also allowed as per investigator's discretion. | 29 | 89 | EG000 |
| Group 2 | Dacomitinib: Cohort B | Participants who had human epidermal growth factor receptor 2 (HER2) gene amplification or HER2 mutation, advanced non-small cell lung cancer (NSCLC) of any histology and had received prior chemotherapy or prior EGFR-targeted therapy, received dacomitinib 45 mg or 30 mg tablet orally daily in cycles of 28 days until progression of disease, unacceptable toxicity, or participant withdrawal. Participants who had not received prior therapy for advanced NSCLC, received 30 mg daily and participants who had received prior systemic therapy for advanced NSCLC, received 45 mg daily as starting dose. Dose escalated to 45 mg in participants after at least 8 weeks of therapy who had started treatment at 30 mg and were tolerating treatment for at least 4 consecutive weeks as per judgment of the investigator. Dose modifications for treatment-related toxicity were allowed for up to 2 dose reductions (to 30 mg and then to 15 mg) if the participant started at 45 mg. | 9 | 30 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- Dacomitinib (PF-00299804) As A Single Oral Agent In Selected Patients With Adenocarcinoma Of The Lung
- NCT number
- NCT00818441
- Phases
- PHASE2
- Conditions
- Carcinoma, Non-small Cell
- Interventions
- Dacomitinib (PF-00299804), Dacomitinib (PF-00299804)
- Lead sponsor
- Pfizer
- Results first posted
- 2016-06-01
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00818441?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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