Comparison · NCT01100931-sae
Phase I vs Phase II: 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. Phase I vs Phase II: serious adverse events. Trial comparisons, record NCT01100931-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01100931-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 | 0.455 | 0.269 | 0.653 | wilson | |
| Risk in group 2 | 0.0526 | 0.00935 | 0.246 | wilson | |
| Risk difference, group 1 minus group 2 | 0.402 | 0.134 | 0.605 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 8.64 | 1.21 | 61.4 | log | |
| Odds ratio, group 1 over group 2 | 15 | 1.69 | 133 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Phase I than on Phase II | 2.49 | 1.65 | 7.47 | from the risk difference interval |
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 | Phase I | Phase I: Doses were given at different dose levels until the maximum tolerated dose (MTD) was reached. Dose level 1: 3.6 mg/m\^2, dose level 2:5 mg/m\^2 , dose level 3:6 mg/m\^2, dose level 4:8 mg/m\^2, dose level 5:10 mg/m\^2 (MTD), dose level 6:12 mg/m\^2. Doses were given by continuous intravenous infusion over 72 hours every 21 days.Three patients were enrolled at each dose level in the absence of dose limiting toxicity (DLT). A DLT is defined as adverse events occurring during the first cycle of therapy (e.g. every 21 days). | 10 | 22 | EG000 |
| Group 2 | Phase II | Phase II: 10 mg/m\^2 (MTD)intravenous infusion over 72 hours every 21 days. | 1 | 19 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- A Phase I/II Study of Paclitaxel, Carboplatin and YM155 (Survivin Suppressor) in Subjects With Solid Tumors (Phase I) and Advanced Non-Small Cell Lung Carcinoma (Phase II)
- NCT number
- NCT01100931
- Phases
- PHASE1, PHASE2
- Conditions
- NSCLC, Solid Tumors
- Interventions
- YM155, Carboplatin, Paclitaxel
- Lead sponsor
- National Cancer Institute (NCI)
- Results first posted
- 2013-04-04
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01100931?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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