Comparison · NCT04187144-ca85f5ef
Gepotidacin vs Nitrofurantoin: Number of Participants With Serious Adverse Events (SAEs)
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. Gepotidacin vs Nitrofurantoin: Number of Participants With Serious Adverse Events (SAEs). Trial comparisons, record NCT04187144-ca85f5ef. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04187144-ca85f5ef
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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 | 0.00622 | 0.00266 | 0.0145 | wilson | |
| Risk in group 2 | 0.00627 | 0.00268 | 0.0146 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0000468 | -0.00909 | 0.00895 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.993 | 0.288 | 3.42 | log | |
| Odds ratio, group 1 over group 2 | 0.992 | 0.286 | 3.44 | log | |
| Number needed to treat, for one fewer participant with the outcome on Gepotidacin than on Nitrofurantoin | 21,400 | 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 | Gepotidacin | Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive gepotidacin 1500 milligram (mg) (2\*750 mg, tablets), twice daily (BID), orally on Day 1 to Day 5. The total daily dose of gepotidacin received was 3000 mg. Participants also received 1 capsule of placebo matched with nitrofurantoin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water. | 5 | 804 | OG000 |
| Group 2 | Nitrofurantoin | Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive nitrofurantoin 100 mg capsule, BID, orally on Day 1 to Day 5. The total daily dose of nitrofurantoin received was 200 mg. Participants also received 2 tablets of placebo matched with gepotidacin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water. | 5 | 798 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With Serious Adverse Events (SAEs)
- Description
An SAE is defined as any untoward medical occurrence that, at any dose may result in death or is life-threatening or requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity or is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment or is associated with liver injury and impaired liver function.
- Time frame
- From the time of first dose (Day 1) through the final follow-up visit (Day 21-31)
- Population
- Safety population included all randomized participants who receive at least 1 dose of study treatment.
Source ClinicalTrials.gov
Trial
- Title
- Comparative Study to Evaluate Efficacy and Safety of Gepotidacin to Nitrofurantoin in Treatment of Uncomplicated Urinary Tract Infection (UTI)
- NCT number
- NCT04187144
- Phases
- PHASE3
- Conditions
- Urinary Tract Infections
- Interventions
- Gepotidacin, Placebo matching nitrofurantoin, Nitrofurantoin, Placebo matching gepotidacin
- Lead sponsor
- GlaxoSmithKline
- Results first posted
- 2023-07-18
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04187144?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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