Comparison · NCT00765999-0afd96bd
Linaclotide (CC) vs Linaclotide (IBS-C): Number of Participants With at Least One 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
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ConductScience Library. Linaclotide (CC) vs Linaclotide (IBS-C): Number of Participants With at Least One Treatment-Emergent Adverse Events (TEAEs). Trial comparisons, record NCT00765999-0afd96bd. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00765999-0afd96bd
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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 | 0.763 | 0.725 | 0.797 | wilson | |
| Risk in group 2 | 0.725 | 0.697 | 0.751 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0381 | -0.00839 | 0.0825 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.05 | 0.99 | 1.12 | log | |
| Odds ratio, group 1 over group 2 | 1.22 | 0.958 | 1.56 | log | |
| Number needed to treat, for one more participant with the outcome on Linaclotide (CC) than on Linaclotide (IBS-C) | 26.2 | 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 | Linaclotide (CC) | Linaclotide 290 μg/day capsules, administered orally once daily for up to 78 weeks in participants with CC. Dose reduction to 145 μg/day was permitted at the discretion of the Investigator if a participant experienced AEs intolerable enough to prompt consideration of study withdrawal. After a temporary suspension of dosing, paticipants may have received either 145 μg/day or 290 μg/day of linaclotide, at the discretion of the Investigator. Subsequent dose adjustments (increases or decreases between 290 μg/day and 145 μg/day) were permitted also at the Investigator's discretion. | 399 | 523 | OG000 |
| Group 2 | Linaclotide (IBS-C) | Linaclotide 290 μg/day capsules, administered orally once daily for up to 78 weeks in participants with IBS-C. Dose reduction to 145 μg/day was permitted at the discretion of the Investigator if a participant experienced AEs intolerable enough to prompt consideration of study withdrawal. After a temporary suspension of dosing, participants may have received either 145 μg/day or 290 μg/day of linaclotide, at the discretion of the Investigator. Subsequent dose adjustments (increases or decreases between 290 μg/day and 145 μg/day) were permitted also at the Investigator's discretion. | 748 | 1,032 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Participants With at Least One Treatment-Emergent Adverse Events (TEAEs)
- Description
An AE is any untoward medical occurrence in a clinical study participant administered study drug. An AE could, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug, whether or not related to the medicinal product. An AE that occurred during the treatment period was defined as a TEAE if the AE was either not present at, or before, the day of the first dose of open-label study medication in this study or was present at, or before, the day of the first dose of open-label study medication in this study and increased in severity during the treatment period. AEs included abnormal clinically significant findings for clinical laboratory tests, physical examination findings, vital sign measurements and electrocardiograms (ECGs).
- Time frame
- Up to 78 weeks for AEs; within 30 days of last dose of study drug (up to 82 weeks) for serious AEs.
- Population
The analysis population consisted of participants in the Enrolled Population who received at least 1 dose of the open-label investigational product. It was identified that 1 participant enrolled twice in the study under 2 ID numbers; this participant is included in both the IBS-C and CC Safety Populations, leading to an analyzed population of 1555.
Source ClinicalTrials.gov
Trial
- Title
- An Open-Label, Long-Term Safety Study of Linaclotide in Patients With Chronic Constipation or Irritable Bowel Syndrome With Constipation
- NCT number
- NCT00765999
- Phases
- PHASE3
- Conditions
- Chronic Constipation, Irritable Bowel Syndrome With Constipation
- Interventions
- Linaclotide
- Lead sponsor
- Forest Laboratories
- Results first posted
- 2019-02-15
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00765999?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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