Comparison · NCT01360554-sae
Arm A (Blinded Dacomitinib and Blinded Erlotinib Placebo) vs Arm B (Blinded Erlotinib and Blinded Dacomitinib Placebo): 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. Arm A (Blinded Dacomitinib and Blinded Erlotinib Placebo) vs Arm B (Blinded Erlotinib and Blinded Dacomitinib Placebo): serious adverse events. Trial comparisons, record NCT01360554-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01360554-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 | 0.408 | 0.363 | 0.455 | wilson | |
| Risk in group 2 | 0.388 | 0.343 | 0.434 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0206 | -0.0442 | 0.0852 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.05 | 0.895 | 1.24 | log | |
| Odds ratio, group 1 over group 2 | 1.09 | 0.831 | 1.43 | log | |
Number needed to harm, for one more participant with a serious adverse event on Arm A (Blinded Dacomitinib and Blinded Erlotinib Placebo) than on Arm B (Blinded Erlotinib and Blinded Dacomitinib Placebo) | 48.4 | 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 | Arm A (Blinded Dacomitinib and Blinded Erlotinib Placebo) | Participants randomized to Arm A received dacomitinib 45 mg orally once daily and erlotinib 150 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death. | 178 | 436 | EG000 |
| Group 2 | Arm B (Blinded Erlotinib and Blinded Dacomitinib Placebo) | Participants randomized to Arm B received erlotinib 150 mg orally once daily and dacomitinib 45 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death. | 169 | 436 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
AE reporting period is from 1st dose of study drug through 28 days after last dose of study drug. SAE reporting period is from informed consent through 28 days after last dose of study drug. The longest duration of treatment in this study was 48 weeks.
Source ClinicalTrials.gov
Trial
- Title
- ARCHER 1009 : A Study Of Dacomitinib (PF-00299804) Vs. Erlotinib In The Treatment Of Advanced Non-Small Cell Lung Cancer
- NCT number
- NCT01360554
- Phases
- PHASE3
- Conditions
- Non-Small Cell Lung Cancer
- Interventions
- Dacomitinib (PF-00299804), Active Comparator (erlotinib), Placebo erlotinib, Placebo PF00299804
- Lead sponsor
- Pfizer
- Results first posted
- 2017-05-24
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01360554?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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