Comparison · NCT03094416-sae
Treatment Period: Tirosint Capsules vs Run-in Period: LT4 Tablets: 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: Tirosint Capsules vs Run-in Period: LT4 Tablets: serious adverse events. Trial comparisons, record NCT03094416-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03094416-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 | 0.0213 | 0.00377 | 0.111 | wilson | |
| Risk in group 2 | 0.0426 | 0.0117 | 0.142 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0213 | -0.123 | 0.0737 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.5 | 0.0469 | 5.33 | log | |
| Odds ratio, group 1 over group 2 | 0.489 | 0.0428 | 5.59 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Treatment Period: Tirosint Capsules than on Run-in Period: LT4 Tablets | 47 | 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 | Treatment Period: Tirosint Capsules | After the run-in period, at baseline visit, subjects were switched to Tirosint (levothyroxine sodium) capsules at the same dose used during run-in and for 3 months (treatment period).~For the whole study duration (run-in and treatment period), subjects kept taking their proton pump inhibitor medication, as per prescription and as before inclusion. | 1 | 47 | EG000 |
| Group 2 | Run-in Period: LT4 Tablets | During the run-in period, subjects continued taking their levothyroxine sodium tablet medication 88 to 250 mcg/day (depending on individual needs) as per prescription and as before inclusion.~For the whole study duration (run-in and treatment period), subjects kept taking their proton pump inhibitor medication, as per prescription and as before inclusion. | 2 | 47 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse events were collected for the whole study duration (from the signature of the informed consent until the end of the study and/or the follow-up planned period), an average of 18 weeks
Source ClinicalTrials.gov
Trial
- Title
- Levothyroxine Sodium in Thyroidectomized Patients Taking Proton Pump Inhibitors
- NCT number
- NCT03094416
- Phases
- PHASE4
- Conditions
- Hypothyroidism;Postablative
- Interventions
- levothyroxine sodium capsule, Proton pump inhibitor (PPI), Levothyroxine Sodium (LT4) Tablets
- Lead sponsor
- IBSA Institut Biochimique SA
- Results first posted
- 2022-04-05
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03094416?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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