Adverse Events Module
For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.
Adverse Events Module path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Groups
Study -> Results Section -> Adverse Events Module -> Serious Events
Study -> Results Section -> Adverse Events Module -> Other Events
Adverse Events Module
Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2025-12-25 @ 9:37 PM
NCT ID:
NCT01969851
Description:
An Adverse Event (AE) was any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment.
Frequency Threshold:
5
Time Frame:
Adverse events were collected throughout the study (up to week 26)
Study:
NCT01969851
Study Brief:
A Study to Investigate the Safety and Efficacy of Lacosamide Added to the Patients Current Therapy in Patients Aged 1 Month to Less Than 18 Years Old With Epilepsy Syndromes Associated With Generalized Seizures.
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Lacosamide 1 Month - <4 Years | Subjects, aged 1 month to \<4 years, who were administered Lacosamide oral solution (for subjects weighing \<50 kg) or tablet (for subjects weighing \>=50 kg). The initial dose of 2 mg/kg/day (for subjects weighing \<50 kg), or 100 mg/day (for subjects weighing \>=50 kg) was titrated to optimize tolerability and seizure control to at least 4 mg/kg/day for subjects weighing \<50 kg, or 200 mg/day for subjects weighing \>=50 kg; not to exceed 12 mg/kg/day for subjects weighing \<50 kg, or 600 mg/day in subjects weighing \>=50 kg. | 0 | None | 0 | 10 | 10 | 10 | View |
| Lacosamide 4 Years - <12 Years | Subjects, aged 4 years to \<12 years, who were administered Lacosamide oral solution (for subjects weighing \<50 kg) or tablet (for subjects weighing \>=50 kg). The initial dose of 2 mg/kg/day (for subjects weighing \<50 kg), or 100 mg/day (for subjects weighing \>=50 kg) was titrated to optimize tolerability and seizure control to at least 4 mg/kg/day for subjects weighing \<50kg, or 200 mg/day for subjects weighing \>=50 kg; not to exceed 12 mg/kg/day for subjects weighing \<50 kg, or 600 mg/day in subjects weighing \>=50 kg. | 0 | None | 0 | 24 | 19 | 24 | View |
| Lacosamide 12 Years - <18 Years | Subjects, aged 12 years to \<18 years, who were administered Lacosamide oral solution (for subjects weighing \<50 kg) or tablet (for subjects weighing \>=50 kg). The initial dose of 2 mg/kg/day (for subjects weighing \<50 kg), or 100 mg/day (for subjects weighing \>=50 kg) was titrated to optimize tolerability and seizure control to at least 4 mg/kg/day for subjects weighing \<50kg, or 200 mg/day for subjects weighing \>=50 kg; not to exceed 12 mg/kg/day for subjects weighing \<50 kg, or 600 mg/day in subjects weighing \>=50 kg. | 0 | None | 1 | 21 | 15 | 21 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Oral herpes | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA16.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA16.1 | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA16.1 | View |
| Ear infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA16.1 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA16.1 | View |
| Tremor | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA16.1 | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA16.1 | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA16.1 | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA16.1 | View |
| Irritability | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA16.1 | View |
| Pharyngotonsillitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA16.1 | View |
| Upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA16.1 | View |
| Bronchitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA16.1 | View |
| Pharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA16.1 | View |
| Decreased appetite | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA16.1 | View |
| Somnolence | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA16.1 | View |
| Convulsion | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA16.1 | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA16.1 | View |
| Rash | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA16.1 | View |