Comparison · NCT03561883-sae
Placebo BID + PPIs vs 1500 mg IW-3718 BID + PPIs: 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. Placebo BID + PPIs vs 1500 mg IW-3718 BID + PPIs: serious adverse events. Trial comparisons, record NCT03561883-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03561883-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 | 0.00987 | 0.00336 | 0.0286 | wilson | |
| Risk in group 2 | 0.00658 | 0.00181 | 0.0237 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00329 | -0.015 | 0.0226 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.5 | 0.252 | 8.91 | log | |
| Odds ratio, group 1 over group 2 | 1.5 | 0.25 | 9.07 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Placebo BID + PPIs than on 1500 mg IW-3718 BID + PPIs | 304 | 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 | Placebo BID + PPIs | Three placebo tablets administered BID immediately after the morning and evening meals. Standard-dose PPIs administered QD approximately 30-60 minutes before morning meal each day. | 3 | 304 | EG000 |
| Group 2 | 1500 mg IW-3718 BID + PPIs | Three IW-3718 tablets administered BID immediately after the morning and evening meals. Standard-dose PPIs administered QD approximately 30-60 minutes before morning meal each day. | 2 | 304 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From first dose of study drug through the end of treatment (up to Week 8) plus 7 days.
Source ClinicalTrials.gov
Trial
- Title
- Trial of IW-3718 for 8 Weeks in Patients With Persistent Gastroesophageal Reflux Disease (GERD) Receiving Proton Pump Inhibitors (PPIs)
- NCT number
- NCT03561883
- Phases
- PHASE3
- Conditions
- Gastroesophageal Reflux Disease (GERD)
- Interventions
- IW-3718, placebo, Standard-dose PPIs QD
- Lead sponsor
- Ironwood Pharmaceuticals, Inc.
- Results first posted
- 2021-08-18
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03561883?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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