Comparison · NCT02799381-sae
Levodopa-Carbidopa Intestinal Gel (LCIG) vs Optimized Medical Treatment (OMT): serious adverse events
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. Levodopa-Carbidopa Intestinal Gel (LCIG) vs Optimized Medical Treatment (OMT): serious adverse events. Trial comparisons, record NCT02799381-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02799381-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 | 0.0714 | 0.0198 | 0.226 | wilson | |
| Risk in group 2 | 0 | 0 | 0.104 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0714 | -0.0449 | 0.226 | 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 harm, for one more participant with a serious adverse event on Levodopa-Carbidopa Intestinal Gel (LCIG) than on Optimized Medical Treatment (OMT) | 14 | 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 | Levodopa-Carbidopa Intestinal Gel (LCIG) | The total daily dose of infusion LCIG was composed of three components: (i) the morning dose, (ii) continuous maintenance infusion dose and (iii) extra doses. A temporary nasojejunal (NJ) tube may have been used initially with the infusion pump to determine a participant's response to this method of treatment and to optimize the dose of LCIG before treatment with a permanent percutaneous endoscopic gastrostomy - with jejunal extension (PEG-J) tube was started. Following optional NJ and/or PEG-J placement and, at the investigator's discretion, the participant may have begun initiation and titration of LCIG infusion on Day 1 once tube placement was confirmed. The dose of LCIG was adjusted to obtain the optimal clinical response. The rate of LCIG infusion is typically within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances and runs over a period of 16 consecutive hours each day. | 2 | 28 | EG000 |
| Group 2 | Optimized Medical Treatment (OMT) | Participants randomized to OMT continued their current anti Parkinson's disease (anti-PD) medication regimen for the duration of the study. All anti-PD medications and medications to treat dyskinesia must have remained stable for the duration of the study unless adjustments were medically indicated. The Investigator provided the prescription for continued OMT. | 0 | 33 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) collection: OMT (starting after the day of randomization until 30 days after the last visit, up to 18 weeks); LCIG group with study tube removal after the last study drug infusion (from the time of tube placement up to 30 days following tube removal, up to 16 weeks); other LCIG participants (starting with tube placement and up to 30 days following the last study visit, up to 16 weeks)
Source ClinicalTrials.gov
Trial
- Title
A Study Comparing Efficacy of Levodopa-Carbidopa Intestinal Gel/Carbidopa-Levodopa Enteral Suspension and Optimized Medical Treatment on Dyskinesia in Subjects With Advanced Parkinson's Disease (DYSCOVER)
- NCT number
- NCT02799381
- Phases
- PHASE3
- Conditions
- Parkinson's Disease (PD)
- Interventions
- Optimized antiparkinsonian treatment, Levodopa-Carbidopa Intestinal Gel (LCIG), CADD-Legacy ambulatory infusion pump, Percutaneous endoscopic gastrostomy tube, Jejunal extension tube
- Lead sponsor
- AbbVie
- Results first posted
- 2020-08-18
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02799381?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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