Trial · NCT03048084
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Ongoing seizure freedom at 6 months | 6 months | The percentage of patients with ongoing seizure freedom at 6 months |
| Secondary | Cumulative incidence of treatment failure for any reason | 36 months | Cumulative incidence function of time to treatment failure for any reason of ASM treatment using competing risk models with death as a competing event. |
| Secondary | Cumulative incidence of treatment failure for specific reasons | 36 months | Cumulative incidence function of time to treatment failure for specific reasons of ASM treatment using competing risk models with death and non-applicable reasons of failure as competing events. Reasons of failure: uncontrolled seizures, adverse effects, other reasons of treatment failure, and death |
| Secondary | Cumulative incidence of a first recurrent seizure | 36 months | Cumulative incidence function of time to occurrence of a first recurrent seizure after ASM initiation using competing risk models with death as a competing event. |
| Secondary | Adverse effects of the treatment | 0, 1, 3, 6, 9, 12, 15, 18, 21, 24, 30 and 36 months or 0, 1, 6, 12, 18, 24 and 30 months, depending on a 3-monthly or 6-monthly follow-up schedule respectively | Severity of adverse effects of the treatment, defined as severity (grade 1-5) of intolerable adverse effects leading to ASM discontinuation according to the Common Terminology Criteria for Adverse- Events (CTCAE) version 5.0 |
| Secondary | Hospitalisation rate | 0, 1, 3, 6, 9, 12, 15, 18, 21, 24, 30 and 36 months or 0, 1, 6, 12, 18, 24 and 30 months, depending on a 3-monthly or 6-monthly follow-up schedule respectively | hospitalization rate due to treatment failure |
| Secondary | Health-related quality of life | 0, 3, 6, 9, 12, 15, 18, 21, 24, 30 and 36 months or 0, 6, 12, 18, 24 and 30 months, depending on a 3-monthly or 6-monthly follow-up schedule respectively | Health-related quality of life |
| Secondary | Cognitive complaints | 0, 3, 6, 9, 12, 15, 18, 21, 24, 30 and 36 months or 0, 6, 12, 18, 24 and 30 months, depending on a 3-monthly or 6-monthly follow-up schedule respectively | Cognitive complaints using MOS-CFS scores |
| Secondary | Mood | 0, 3, 6, 9, 12, 15, 18, 21, 24, 30 and 36 months or 0, 6, 12, 18, 24 and 30 months, depending on a 3-monthly or 6-monthly follow-up schedule respectively | Anxiety and depression using HADS scale scores |
| Secondary | Performance Status | 0, 3, 6, 9, 12, 15, 18, 21, 24, 30 and 36 months or 0, 6, 12, 18, 24 and 30 months, depending on a 3-monthly or 6-monthly follow-up schedule respectively | Karnofsky Performance Status Score |
| Secondary | Epilepsy burden | 0, 3, 6, 9, 12, 15, 18, 21, 24, 30 and 36 months or 0, 6, 12, 18, 24 and 30 months, depending on a 3-monthly or 6-monthly follow-up schedule respectively | Epilepsy burden |
| Secondary | Treatment response | 0, 1, 3, 6, 9, 12, 15, 18, 21, 24, 30 and 36 months or 0, 1, 6, 12, 18, 24 and 30 months, depending on a 3-monthly or 6-monthly follow-up schedule respectively | Treatment response (e.g., maximum dosage of AED, use of add-on AED) |
| Secondary | Progression-free survival | 0, 1, 3, 6, 9, 12, 15, 18, 21, 24, 30 and 36 months or 0, 1, 6, 12, 18, 24 and 30 months, depending on a 3-monthly or 6-monthly follow-up schedule respectively | Progression-free survival |
| Secondary | Overall survival | 0, 1, 3, 6, 9, 12, 15, 18, 21, 24, 30 and 36 months or 0, 1, 6, 12, 18, 24 and 30 months, depending on a 3-monthly or 6-monthly follow-up schedule respectively | Overall survival |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
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
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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