Comparison · NCT03093870-e0acb9b2
Varlitinib and Capecitabine vs Placebo and Capecitabine: Number of Participants With Clinically Significant Change in Vital Signs and Physical Examinations - Part 1
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. Varlitinib and Capecitabine vs Placebo and Capecitabine: Number of Participants With Clinically Significant Change in Vital Signs and Physical Examinations - Part 1. Trial comparisons, record NCT03093870-e0acb9b2. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03093870-e0acb9b2
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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 | 0 | 0.0566 | wilson | |
| Risk in group 2 | 0 | 0.00000000000000000347 | 0.0575 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.0575 | 0.0566 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| 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 | Varlitinib and Capecitabine | Varlitinib: Varlitinib:300mg, oral tablets, twice daily. Number of cycles: until disease progression, unacceptable toxicity, withdrawal of consent, or death.~Capecitabine: 1000mg/m2, oral tablets, twice daily for 2 weeks followed by a 1-week rest period in 3-week cycles. Number of cycles: until disease progression, unacceptable toxicity, withdrawal of consent, or death. | 0 | 64 | OG000 |
| Group 2 | Placebo and Capecitabine | Placebo (for Varlitinib): oral tablets, twice daily. Number of cycles: until disease progression, unacceptable toxicity, withdrawal of consent, or death.~Capecitabine: 1000mg/m2, oral tablets, twice daily for 2 weeks followed by a 1-week rest period in 3-week cycles. Number of cycles: until disease progression, unacceptable toxicity, withdrawal of consent, or death. | 0 | 63 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With Clinically Significant Change in Vital Signs and Physical Examinations - Part 1
- Description
- Number of participants with clinically significant change in vital signs (blood pressure \[diastolic and systolic\], heart rate, respiratory rate, body temperature) and physical examination.
- Time frame
- Subject screening visit to 28 days post last study drug administration
- Population
Source ClinicalTrials.gov
Trial
- Title
- Varlitinib in Combination With Capecitabine for Advanced or Metastatic Biliary Tract Cancer
- NCT number
- NCT03093870
- Phases
- PHASE2, PHASE3
- Conditions
- Biliary Tract Cancer
- Interventions
- Varlitinib, Capecitabine, Placebo (for Varlitinib)
- Lead sponsor
- ASLAN Pharmaceuticals
- Results first posted
- 2021-08-03
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03093870?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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