Comparison · NCT03158805-sae
Active Drug 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. Active Drug vs Placebo: serious adverse events. Trial comparisons, record NCT03158805-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03158805-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 | 0 | 0.117 | wilson | |
| Risk in group 2 | 0.0645 | 0.0179 | 0.207 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0645 | -0.207 | 0.0614 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to treat, for one fewer participant with a serious adverse event on Active Drug than on Placebo | 15.5 | 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 | Active Drug | Significantly more placebo recipients (n=11) than liraglutide recipients (n=3) stopped study medication for a side effect (p=0.02). Those who discontinued liraglutide stopped because of gastrointestinal issues (n=1), mood dysregulation (n=1), and suicidal ideation (n=1). No adverse event was judged to reflect an interaction between liraglutide and participants' BD medications. There were no changes in psychopathology safety scales or vital signs. No participants experienced psychosis, displayed suicidal behaviour, or had ECG changes during the study. | 0 | 29 | EG000 |
| Group 2 | Placebo | Significantly more placebo recipients (n=11) than liraglutide recipients (n=3) stopped study medication for a side effect (p=0.02). Those who discontinued placebo did so for mood dysregulation (n=5), gastrointestinal issues (n=4), and suicidal ideation (n=2). Two participants receiving placebo had a serious adverse event- one was medically hospitalized for a bowel obstruction presumed due to past bariatric surgery while the other was psychiatrically hospitalized for mood dysregulation-neither adverse event was attributed to study medication. There were no changes in psychopathology safety scales or vital signs . No participants experienced psychosis, displayed suicidal behaviour, or had ECG changes during the study. | 2 | 31 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Through study completion, for the total duration of the trial, including up to 27 days of screening , the 40 study treatment weeks and one week of follow up
Source ClinicalTrials.gov
Trial
- Title
- Saxenda® in Obese or Overweight Patients With Stable Bipolar Disorder (Investigator Initiated)
- NCT number
- NCT03158805
- Phases
- PHASE2
- Conditions
- Bipolar Disorder, Obesity
- Interventions
- LIRAGLUTIDE, Placebo
- Lead sponsor
- Lindner Center of HOPE
- Results first posted
- 2024-03-27
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03158805?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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