Comparison · NCT01688973-sae
Arm I (Tivantinib) vs Arm II (Tivantinib and Erlotinib Hydrochloride): 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. Arm I (Tivantinib) vs Arm II (Tivantinib and Erlotinib Hydrochloride): serious adverse events. Trial comparisons, record NCT01688973-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01688973-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 | 0.36 | 0.202 | 0.555 | wilson | |
| Risk in group 2 | 0.64 | 0.445 | 0.798 | wilson | |
| Risk difference, group 1 minus group 2 | -0.28 | -0.503 | -0.00449 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.563 | 0.309 | 1.02 | log | |
| Odds ratio, group 1 over group 2 | 0.316 | 0.0997 | 1 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Arm I (Tivantinib) than on Arm II (Tivantinib and Erlotinib Hydrochloride) | 3.57 | 1.99 | 223 | 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 | Arm I (Tivantinib) | Patients receive tivantinib PO BID on days 1-28.~Laboratory Biomarker Analysis: Correlative studies~Tivantinib: Given PO | 9 | 25 | EG000 |
| Group 2 | Arm II (Tivantinib and Erlotinib Hydrochloride) | Patients receive tivantinib PO BID and erlotinib hydrochloride PO QD on days 1-28.~Erlotinib Hydrochloride: Given PO~Laboratory Biomarker Analysis: Correlative studies~Tivantinib: Given PO | 16 | 25 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Up to 3 years
Source ClinicalTrials.gov
Trial
- Title
- Tivantinib With or Without Erlotinib Hydrochloride in Treating Patients With Metastatic or Locally Advanced Kidney Cancer That Cannot Be Removed by Surgery
- NCT number
- NCT01688973
- Phases
- PHASE2
- Conditions
- Recurrent Renal Cell Carcinoma, Stage III Renal Cell Cancer, Stage IV Renal Cell Cancer, Type 1 Papillary Renal Cell Carcinoma, Type 2 Papillary Renal Cell Carcinoma
- Interventions
- Erlotinib Hydrochloride, Laboratory Biomarker Analysis, Tivantinib
- Lead sponsor
- National Cancer Institute (NCI)
- Results first posted
- 2019-01-03
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01688973?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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