Comparison · NCT05033080-sae
ELX/TEZ/IVA vs VNZ/TEZ/D-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. ELX/TEZ/IVA vs VNZ/TEZ/D-IVA: serious adverse events. Trial comparisons, record NCT05033080-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT05033080-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 | 0.203 | 0.153 | 0.264 | wilson | |
| Risk in group 2 | 0.143 | 0.101 | 0.199 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0601 | -0.0146 | 0.134 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.42 | 0.916 | 2.2 | log | |
| Odds ratio, group 1 over group 2 | 1.53 | 0.902 | 2.59 | log | |
| Number needed to harm, for one more participant with a serious adverse event on ELX/TEZ/IVA than on VNZ/TEZ/D-IVA | 16.6 | 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 | ELX/TEZ/IVA | Following ELX/TEZ/IVA run-in period of 4 weeks, participants received ELX 200 mg qd /TEZ 100 mg qd/IVA 150 mg q12h in the treatment period for 52 weeks. | 41 | 202 | EG000 |
| Group 2 | VNZ/TEZ/D-IVA | Following ELX/TEZ/IVA run-in period of 4 weeks, participants received VX-121 20 mg qd/TEZ 100 mg qd/D-IVA 250 mg qd in the treatment period for 52 weeks. | 28 | 196 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Day 1 up to Safety follow-up (up to 56 weeks)
Source ClinicalTrials.gov
Trial
- Title
- A Phase 3 Study of VX-121 Combination Therapy in Participants With Cystic Fibrosis (CF) Heterozygous for F508del and a Minimal Function Mutation (F/MF)
- NCT number
- NCT05033080
- Phases
- PHASE3
- Conditions
- Cystic Fibrosis
- Interventions
- VX-121/TEZ/D-IVA, ELX/TEZ/IVA, IVA, Placebo (matched to VX-121/TEZ/D-IVA), Placebo (matched to ELX/TEZ/IVA), Placebo (matched to IVA)
- Lead sponsor
- Vertex Pharmaceuticals Incorporated
- Results first posted
- 2024-06-10
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT05033080?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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