Comparison · NCT00461708-sae
Erlotinib, Gemcitabine: Rash Grade < 2 vs Erlotinib, Gemcitabine: Rash Grade ≥ 2: 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. Erlotinib, Gemcitabine: Rash Grade < 2 vs Erlotinib, Gemcitabine: Rash Grade ≥ 2: serious adverse events. Trial comparisons, record NCT00461708-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00461708-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 | 0.504 | 0.414 | 0.594 | wilson | |
| Risk in group 2 | 0.368 | 0.234 | 0.527 | wilson | |
| Risk difference, group 1 minus group 2 | 0.136 | -0.0466 | 0.298 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.37 | 0.869 | 2.16 | log | |
| Odds ratio, group 1 over group 2 | 1.74 | 0.821 | 3.71 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Erlotinib, Gemcitabine: Rash Grade < 2 than on Erlotinib, Gemcitabine: Rash Grade ≥ 2 | 7.36 | 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 | Erlotinib, Gemcitabine: Rash Grade < 2 | Participants with a rash Grade \< 2 according to the National NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m\^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. | 58 | 115 | EG000 |
| Group 2 | Erlotinib, Gemcitabine: Rash Grade ≥ 2 | Participants with a rash Grade ≥ 2 according to the NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m\^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. | 14 | 38 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse events (AEs) were recorded at every study visit for up to a maximum of 24 treatment cycles.
Source ClinicalTrials.gov
Trial
- Title
- A Study of Tarceva (Erlotinib) in Combination With Gemcitabine in Unresectable and/or Metastatic Cancer of the Pancreas: Relationship Between Skin Toxicity and Survival
- NCT number
- NCT00461708
- Phases
- PHASE2
- Conditions
- Pancreatic Cancer
- Interventions
- Erlotinib, Gemcitabine
- Lead sponsor
- Hoffmann-La Roche
- Results first posted
- 2015-10-15
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00461708?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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