Comparison · NCT01143246-sae
Terlipressin vs Placebo: 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. Terlipressin vs Placebo: serious adverse events. Trial comparisons, record NCT01143246-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01143246-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 | 0.667 | 0.566 | 0.754 | wilson | |
| Risk in group 2 | 0.621 | 0.521 | 0.712 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0456 | -0.0902 | 0.179 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.07 | 0.868 | 1.33 | log | |
| Odds ratio, group 1 over group 2 | 1.22 | 0.671 | 2.22 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Terlipressin than on Placebo | 21.9 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Terlipressin | Participants receive terlipressin intravenously as a bolus injection, followed by a saline flush. Dose, duration, retreatment and/or discontinuation may be modified by the investigator, per protocol. | 62 | 93 | EG000 |
| Group 2 | Placebo | Participants receive matching placebo intravenously as a bolus injection, followed by a saline flush. Dose, duration, retreatment and/or discontinuation may be modified by the investigator, per protocol. | 59 | 95 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
All-cause mortality was reported for the ITT population. SAEs are collected in the safety analysis set (SAS) from informed consent to 30 days post-treatment (up to approximately 44 days); deaths are collected through study completion at 90 days from treatment start. Other adverse events were collected up to 7 days of treatment.
Source ClinicalTrials.gov
Trial
- Title
- A Placebo-Controlled, Double-Blind Study to Confirm the Reversal of Hepatorenal Syndrome Type 1 With Terlipressin
- NCT number
- NCT01143246
- Phases
- PHASE3
- Conditions
- Hepatorenal Syndrome
- Interventions
- Terlipressin, Placebo
- Lead sponsor
- Mallinckrodt
- Results first posted
- 2022-11-29
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01143246?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.
For software
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