Comparison · NCT04043806-deaths
Part A: ELX/TEZ/IVA vs Part B: ELX/TEZ/IVA: deaths from any cause
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Part A: ELX/TEZ/IVA vs Part B: ELX/TEZ/IVA: deaths from any cause. Trial comparisons, record NCT04043806-deaths. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04043806-deaths
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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 | 0.00834 | wilson | |
| Risk in group 2 | 0 | 0 | 0.055 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.055 | 0.00834 | 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 harm | 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 | Part A: ELX/TEZ/IVA | Participants received ELX 200 mg qd, TEZ 100 mg qd, and IVA 150 mg q12h in the treatment period for 96 weeks. | 0 | 457 | EG000 |
| Group 2 | Part B: ELX/TEZ/IVA | Participants from certain countries participated in Part B and continued to received ELX 200 mg qd /TEZ 100 mg qd/IVA 150 mg q12h in the treatment period for 48 weeks. | 0 | 66 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, all-cause mortality
- Time frame
- Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
Source ClinicalTrials.gov
Trial
- Title
- A Study Evaluating the Long-term Safety of VX-445 Combination Therapy
- NCT number
- NCT04043806
- Phases
- PHASE3
- Conditions
- Cystic Fibrosis
- Interventions
- ELX/TEZ/IVA, IVA
- Lead sponsor
- Vertex Pharmaceuticals Incorporated
- Results first posted
- 2023-07-06
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04043806?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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