Comparison · NCT03689114-sae
Low Dose vs Standard Dose: 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. Low Dose vs Standard Dose: serious adverse events. Trial comparisons, record NCT03689114-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03689114-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 | 0.069 | 0.0191 | 0.22 | wilson | |
| Risk in group 2 | 0.0345 | 0.00611 | 0.172 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0345 | -0.112 | 0.188 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2 | 0.192 | 20.9 | log | |
| Odds ratio, group 1 over group 2 | 2.07 | 0.178 | 24.2 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Low Dose than on Standard Dose | 29 | 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 | Low Dose | Dosage is in mg: low dose carbamazepine, 300; low dose levetiracetam, 500; low dose valproate, 300; low dose zonisamide, 150; low dose oxcarbazepine, 600; low dose topiramate, 100; low dose lamotrigine, 100; low dose gabapentin, 450; low dose lacosamide 100 mg. Study drugs are in form of tablets for daily administration. Study drug administration duration is 12 months. The choice of the drug is left to the caring physician's discretion but it must be limited to the AEDs marketed for monotherapy use. All the study drugs will be used according to the respective SPCs, which will be sent by the promoter to all the study investigators.~The arm/group low dose includes all the interventions listed above which correspond to low dose of each antiepileptic monotherapy.~All the results were grouped by arm/group. In the adverse events tables all the single drugs were specified in each arm/group.~The aim of this study was to compare the low dose arm/group versus the standard dose arm/group independently from the specific intervention/drug prescribed by the neurologist. Randomization was done by dose and not by drug. The drug has been chosen by the treating physician. | 2 | 29 | EG000 |
| Group 2 | Standard Dose | Dosage is in mg: standard dose carbamazepine 600; standard dose levetiracetam 1000; standard dose valproate, 600; standard dose zonisamide 300; standard dose oxcarbazepine 1200; standard dose topiramate, 200; standard dose lamotrigine, 200; standard dose gabapentin 900; standard dose lacosamide 200 mg. Study drugs are in form of tablets for daily administration. Study drug administration duration is 12 months. The choice of the drug is left to the caring physician's discretion but it must be limited to the AEDs marketed for monotherapy use. All the study drugs will be used according to the respective SPCs, which will be sent by the promoter to all the study investigators.~The arm/group standard dose includes all the interventions listed above which correspond to standard dose of each antiepileptic monotherapy.~All the results were grouped by arm/group. In the adverse events tables all the single drugs were specified in each arm/group.~The aim of this study was to compare the low dose arm/group versus the standard dose arm/group independently from the specific intervention/drug prescribed by the neurologist. Randomization was done by dose and not by drug. The drug has been chosen by the treating physician. | 1 | 29 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 12 months
Source ClinicalTrials.gov
Trial
- Title
- Low vs. Standard Daily Doses of Antiepileptic Drugs in Newly Diagnosed, Previously Untreated Epilepsy(STANDLOW)
- NCT number
- NCT03689114
- Phases
- PHASE4
- Conditions
- Epilepsies, Partial
- Interventions
Low dose carbamazepine, Standard dose carbamazepine, Low dose levetiracetam, Standard dose levetiracetam, Low dose valproate, Standard dose valproate, Low dose zonisamide, Standard dose zonisamide, Low dose oxcarbazepine, Standard dose oxcarbazepine, Low dose topiramate, Standard dose topiramate, Low dose lamotrigine, Standard dose lamotrigine, Low dose gabapentin, Standard dose gabapentin
- Lead sponsor
- Mario Negri Institute for Pharmacological Research
- Results first posted
- 2025-07-08
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03689114?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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