Comparison · NCT01130519-729dedce
COHORT 1&3 Advanced Renal Cell Cancer Associated With Hereditary Leiomyomatosis & Renal Cell Cancer vs COHORT 2 and 4 - Sporadic Papillary Renal Cell Cancer: Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0)
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. COHORT 1&3 Advanced Renal Cell Cancer Associated With Hereditary Leiomyomatosis & Renal Cell Cancer vs COHORT 2 and 4 - Sporadic Papillary Renal Cell Cancer: Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). Trial comparisons, record NCT01130519-729dedce. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01130519-729dedce
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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 | 1 | 0.918 | 1 | wilson | |
| Risk in group 2 | 1 | 0.912 | 1 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.082 | 0.0876 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1 | 1 | 1 | log | |
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to treat | from the risk difference interval | the two groups' risks are equal |
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 | COHORT 1&3 Advanced Renal Cell Cancer Associated With Hereditary Leiomyomatosis & Renal Cell Cancer | COHORT 1 - Advanced Renal Cell Cancer Associated with Hereditary Leiomyomatosis and Renal Cell Cancer~All participants will be receiving fixed starting dose of bevacizumab (10 mg/kg intravenous (IV) every 2 weeks) and erlotinib (150 mg/day by mouth (PO).~Participants with metastatic Hereditary Leiomyomatosis and Renal Cell Cancer (HLRCC), diagnosed by either germline mutation of the fumarate hydratase (FH) gene, or based upon evidence of the clinical syndrome of HLRCC (characteristic renal cancer histology, cutaneous leiomyomas, uterine fibroids, and a family history).~COHORT 3 - Hereditary Leiomyomatosis and Renal Cell Cancer Associated Kidney Cancer~All participants will be receiving fixed starting dose of bevacizumab (10 mg/kg intravenous (IV) every 2 weeks) and erlotinib (150 mg/day by mouth (PO).~Participants with metastatic Hereditary Leiomyomatosis and Renal Cell Cancer (HLRCC), diagnosed by either germline mutation of the fumarate hydratase (FH) gene, or based upon evidence of the clinical syndrome of HLRCC (characteristic renal cancer histology, cutaneous leiomyomas, uterine fibroids, and a family history). | 43 | 43 | OG000 |
| Group 2 | COHORT 2 and 4 - Sporadic Papillary Renal Cell Cancer | COHORT 2 - Sporadic Papillary Renal Cell Cancer~All participants will be receiving fixed starting dose of bevacizumab (10 mg/kg intravenous (IV) every 2 weeks) and erlotinib (150 mg/day by mouth (PO).~Participants with sporadic papillary renal cancer.~COHORT 4 - Sporadic/NonHereditary Leiomyomatosis and Renal Cell Cancer Papillary Kidney Cancer~All participants will be receiving fixed starting dose of bevacizumab (10 mg/kg intravenous (IV) every 2 weeks) and erlotinib (150 mg/day by mouth (PO).~Participants with sporadic papillary renal cancer. | 40 | 40 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- OTHER_PRE_SPECIFIED
- Title
- Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0)
- Description
Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
- Time frame
- Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively.
- Population
As pre-specified by the protocol for reporting purposes, our expansion cohorts were combined with the original cohorts (i.e., cohort 1, cohort 2, cohort 3, and cohort 4). Therefore, we reported on two groups: all Hereditary Leiomyomatosis and Renal Cell Cancer (HLRCC) participants (Cohorts 1 \& 3) and all sporadic participants (Cohort 2 \& 4).
Source ClinicalTrials.gov
Trial
- Title
- A Phase II Study of Bevacizumab and Erlotinib in Subjects With Advanced Hereditary Leiomyomatosis and Renal Cell Cancer (HLRCC) or Sporadic Papillary Renal Cell Cancer
- NCT number
- NCT01130519
- Phases
- PHASE2
- Conditions
- HLRCC, Sporadic Papillary Renal Cell Cancer
- Interventions
- Bevacizumab, Erlotinib
- Lead sponsor
- National Cancer Institute (NCI)
- Results first posted
- 2023-08-01
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01130519?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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