Comparison · NCT03525574-sae
Treatment Period: ELX/TEZ/IVA vs Extension Period: ELX/TEZ/IVA: serious adverse events
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. Treatment Period: ELX/TEZ/IVA vs Extension Period: ELX/TEZ/IVA: serious adverse events. Trial comparisons, record NCT03525574-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03525574-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 | 0.346 | 0.306 | 0.388 | wilson | |
| Risk in group 2 | 0 | 0 | 0.259 | wilson | |
| Risk difference, group 1 minus group 2 | 0.346 | 0.0839 | 0.388 | 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, for one more participant with a serious adverse event on Treatment Period: ELX/TEZ/IVA than on Extension Period: ELX/TEZ/IVA | 2.89 | 2.58 | 11.9 | 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 | Treatment Period: ELX/TEZ/IVA | Participants received ELX 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in the treatment period for 192 weeks. | 175 | 506 | EG000 |
| Group 2 | Extension Period: ELX/TEZ/IVA | Participants from certain countries participated in extension period and continued to receive ELX 200 mg qd /TEZ 100 mg qd/IVA 150 mg q12h in the extension period for 48 weeks. | 0 | 11 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
Source ClinicalTrials.gov
Trial
- Title
- A Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy
- NCT number
- NCT03525574
- Phases
- PHASE3
- Conditions
- Cystic Fibrosis
- Interventions
- ELX/TEZ/IVA, IVA
- Lead sponsor
- Vertex Pharmaceuticals Incorporated
- Results first posted
- 2024-05-08
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03525574?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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GET https://conductscience.org/api/comparisons/v1/NCT03525574-sae