Comparison · NCT03525444-sae
VX-445/TEZ/IVA TC vs Placebo: 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. VX-445/TEZ/IVA TC vs Placebo: serious adverse events. Trial comparisons, record NCT03525444-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03525444-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 | 0.139 | 0.0977 | 0.193 | wilson | |
| Risk in group 2 | 0.209 | 0.158 | 0.27 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0703 | -0.144 | 0.0039 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.663 | 0.429 | 1.03 | log | |
| Odds ratio, group 1 over group 2 | 0.609 | 0.361 | 1.03 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on VX-445/TEZ/IVA TC than on Placebo | 14.2 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | VX-445/TEZ/IVA TC | Participants who received VX-445 200 mg/TEZ 100 mg/IVA150 mg as FDC tablets in the morning and IVA 150 mg as mono tablet in the evening for 24 weeks in the TC treatment period. | 28 | 202 | EG001 |
| Group 2 | Placebo | Participants who received placebo matched to VX-445/TEZ/IVA in the morning and placebo matched to IVA in the evening for 24 weeks in the TC treatment period. | 42 | 201 | EG000 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From first dose of study drug in TC treatment period up to 28 days after last dose of study drug or to the completion of study participation date, whichever occurs first (up to 28 weeks)
Source ClinicalTrials.gov
Trial
- Title
- A Phase 3 Study of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)
- NCT number
- NCT03525444
- Phases
- PHASE3
- Conditions
- Cystic Fibrosis
- Interventions
- VX-445/TEZ/IVA, IVA, Placebo
- Lead sponsor
- Vertex Pharmaceuticals Incorporated
- Results first posted
- 2020-05-19
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03525444?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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