Comparison · NCT02590432-sae
LINZESS® 145 μg (CIC) vs LINZESS® 290 μg (IBS-C): 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. LINZESS® 145 μg (CIC) vs LINZESS® 290 μg (IBS-C): serious adverse events. Trial comparisons, record NCT02590432-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02590432-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 | 0.0315 | 0.0195 | 0.0505 | wilson | |
| Risk in group 2 | 0.0189 | 0.00868 | 0.0405 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0126 | -0.0122 | 0.0342 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.67 | 0.66 | 4.22 | log | |
| Odds ratio, group 1 over group 2 | 1.69 | 0.655 | 4.37 | log | |
| Number needed to harm, for one more participant with a serious adverse event on LINZESS® 145 μg (CIC) than on LINZESS® 290 μg (IBS-C) | 79.2 | 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 | LINZESS® 145 μg (CIC) | LINZESS® 145 μg capsules, orally, once daily for up to 52 weeks for participants with CIC. If an Intolerable AE occurred participants could be randomized to the Double-blind Treatment Period (145 μg or 72 μg) or entered the Dose-reduced 72 μg Open Label Period. | 16 | 508 | EG000 |
| Group 2 | LINZESS® 290 μg (IBS-C) | LINZESS® 290 μg capsules, orally, once daily for up to 52 weeks for participants with IBS-C. If an intolerable AE occurred participants could be randomized to the Double-blind Treatment Period (290 μg, 145 μg or 72 μg) or entered the Dose-reduced 72 μg Open Label Period. | 6 | 318 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From first dose of study treatment up to 1 day post last dose for non-serious adverse events and up to 30 days post last dose of study treatment for serious adverse events (Up to 56 Weeks)
Source ClinicalTrials.gov
Trial
- Title
An Open-Label, Long-term Study to Assess the Immunogenicity of LINZESS® (Linaclotide) Administered Orally to Adult Participants With Irritable Bowel Syndrome With Constipation or Chronic Idiopathic Constipation
- NCT number
- NCT02590432
- Phases
- PHASE4
- Conditions
- Irritable Bowel Syndrome With Constipation, Chronic Idiopathic Constipation
- Interventions
- Linaclotide
- Lead sponsor
- Forest Laboratories
- Results first posted
- 2019-08-22
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02590432?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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