Comparison · NCT05630833-5f5e138e
Gepotidacin vs Nitrofurantoin: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
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 Treatment-emergent Adverse Events (TEAEs). Trial comparisons, record NCT05630833-5f5e138e. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT05630833-5f5e138e
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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 | 0.715 | 0.66 | 0.765 | wilson | |
| Risk in group 2 | 0.194 | 0.126 | 0.285 | wilson | |
| Risk difference, group 1 minus group 2 | 0.522 | 0.415 | 0.605 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 3.7 | 2.42 | 5.63 | log | |
| Odds ratio, group 1 over group 2 | 10.5 | 5.88 | 18.6 | log | |
| Number needed to treat, for one more participant with the outcome on Gepotidacin than on Nitrofurantoin | 1.92 | 1.65 | 2.41 | 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 | Gepotidacin | Participants with uncomplicated urinary tract infection (uUTI) (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. | 201 | 281 | 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. | 18 | 93 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With Treatment-emergent Adverse Events (TEAEs)
- Description
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. TEAE is defined as any AE with an onset date on or after treatment start date/time. AEs were coded using Medical Dictionary for Regulatory Activities (MedDRA).
- Time frame
- From first dose (Day 1) to Follow-up visit (Days 21 to 31)
- Population
- Safety Population included all randomized participants (except for 6 participants from the site with GCP violation) who received at least 1 dose of study treatment.
Source ClinicalTrials.gov
Trial
- Title
- A Study to Investigate the Efficacy and Safety With Gepotidacin in Japanese Female Participants With Uncomplicated Urinary Tract Infection (Acute Cystitis)
- NCT number
- NCT05630833
- Phases
- PHASE3
- Conditions
- Urinary Tract Infections
- Interventions
- Gepotidacin, Nitrofurantoin, Placebo
- Lead sponsor
- GlaxoSmithKline
- Results first posted
- 2025-03-17
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT05630833?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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