Comparison · NCT01286753-sae
TKI Naive vs TKI Experienced: 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. TKI Naive vs TKI Experienced: serious adverse events. Trial comparisons, record NCT01286753-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01286753-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 | 0.615 | 0.425 | 0.776 | wilson | |
| Risk in group 2 | 0.72 | 0.524 | 0.857 | wilson | |
| Risk difference, group 1 minus group 2 | -0.105 | -0.339 | 0.148 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.855 | 0.579 | 1.26 | log | |
| Odds ratio, group 1 over group 2 | 0.622 | 0.192 | 2.02 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on TKI Naive than on TKI Experienced | 9.56 | 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 | TKI Naive | Vemurafenib 960 mg orally twice daily in participants naive to any prior systemic TKI therapy. | 16 | 26 | EG000 |
| Group 2 | TKI Experienced | Vemurafenib 960 mg orally twice daily in participants previously treated with TKI therapy active against VEGFR. | 18 | 25 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Baseline until 28 days after the last dose of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 4 years)
Source ClinicalTrials.gov
Trial
- Title
- A Study of Vemurafenib (RO5185426) in Participants With Metastatic or Unresectable Papillary Thyroid Cancer Positive for the BRAF V600 Mutation
- NCT number
- NCT01286753
- Phases
- PHASE2
- Conditions
- Neoplasms
- Interventions
- Vemurafenib
- Lead sponsor
- Hoffmann-La Roche
- Results first posted
- 2016-09-07
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01286753?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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