Comparison · NCT01041781-sae
Arm I (Arm A: Celecoxib + Standard Chemotherapy) vs Arm II (Arm B: Placebo + Standard 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. Arm I (Arm A: Celecoxib + Standard Chemotherapy) vs Arm II (Arm B: Placebo + Standard Chemotherapy): serious adverse events. Trial comparisons, record NCT01041781-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01041781-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 | 0.212 | 0.154 | 0.286 | wilson | |
| Risk in group 2 | 0.142 | 0.0947 | 0.207 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0704 | -0.0172 | 0.158 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.5 | 0.903 | 2.48 | log | |
| Odds ratio, group 1 over group 2 | 1.63 | 0.887 | 3 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Arm I (Arm A: Celecoxib + Standard Chemotherapy) than on Arm II (Arm B: Placebo + Standard Chemotherapy) | 14.2 | 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 | Arm I (Arm A: Celecoxib + Standard Chemotherapy) | Patients receive 1000 mg/m\^2 gemcitabine hydrochloride IV on days 1 and 8 (for those with squamous carcinoma) OR 500 mg/m\^2 pemetrexed disodium IV on day 1 (for those with non-squamous carcinoma). Patients also receive (Squamous carcinoma patients: AUC=5.5 (Patient with prior chest radiotherapy should receive carboplatin at an AUC = 5.0); Non-squamous carcinoma patients: AUC=6.0) carboplatin IV on day 1 and 400 mg oral celecoxib twice daily on days 1-21. Patients may receive a maximum of 6 cycles of therapy (1 cycle = 21 days). Following 6 cycles of therapy, those patients with responding or stable disease will continue on the celecoxib/placebo until disease progression or unacceptable toxicity. | 31 | 146 | EG000 |
| Group 2 | Arm II (Arm B: Placebo + Standard Chemotherapy) | Patients receive 1000 mg/m\^2 gemcitabine hydrochloride IV on days 1 and 8 (for those with squamous carcinoma) OR 500 mg/m\^2 pemetrexed disodium IV on day 1 (for those with non-squamous carcinoma). Patients also receive (Squamous carcinoma patients: AUC=5.5; Non-squamous carcinoma patients: AUC=6.0) carboplatin IV on day 1 and placebo twice daily on days 1-21. Patients may receive a maximum of 6 cycles of therapy (1 cycle = 21 days). | 21 | 148 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Source ClinicalTrials.gov
Trial
- Title
- Gemcitabine Hydrochloride or Pemetrexed Disodium and Carboplatin With or Without Celecoxib in Treating Patients With Advanced Non-Small Cell Lung Cancer
- NCT number
- NCT01041781
- Phases
- PHASE3
- Conditions
- Lung Cancer
- Interventions
- carboplatin, celecoxib, gemcitabine hydrochloride, pemetrexed disodium, placebo
- Lead sponsor
- Alliance for Clinical Trials in Oncology
- Results first posted
- 2018-07-23
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01041781?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.
For software
Read this comparison from software.
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GET https://conductscience.org/api/comparisons/v1/NCT01041781-sae