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:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2025-12-26 @ 12:33 AM
NCT ID:
NCT01964560
Description:
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
Frequency Threshold:
5
Time Frame:
From Week 0 to the End of Safety Follow-Up (up to Week 104)
Study:
NCT01964560
Study Brief:
A Clinical Study to Investigate the Efficacy and Safety of Lacosamide as an Add on Therapy in Children With Epilepsy With Partial-onset 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 (All Subjects) | Participants who participated in primary study \[SP0967 (NCT02477839) or SP0969 (NCT01921205)\] consented and met requirements to participate in current study received LCM 10 milligram/kilogram/day (mg/kg/day) as an oral solution for study participants weighing \<30 kg, LCM 6 mg/kg/day as an oral solution for study participants weighing \>=30 kg to \<50 kg, and LCM 300 mg/day as tablets for study participants weighing \>=50 kg. LCM was administered twice daily (bid) up to Week 96. After 1 week the investigator might adjust the LCM dose during the Treatment based on clinical judgment within a range of 2 mg/kg/day to 12 mg/kg/day for the oral solution and 100 mg/day to 600 mg/day for the tablets. | 7 | None | 111 | 540 | 289 | 540 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Cardiac arrest | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v16.1 | View |
| Cerebral palsy | NON_SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA v16.1 | View |
| Talipes | NON_SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA v16.1 | View |
| Blepharitis | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v16.1 | View |
| Diplopia | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v16.1 | View |
| Parophthalmia | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v16.1 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v16.1 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v16.1 | View |
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v16.1 | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v16.1 | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v16.1 | View |
| Enterocolitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v16.1 | View |
| Gastrointestinal motility disorder | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v16.1 | View |
| Gingival bleeding | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v16.1 | View |
| Intestinal obstruction | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v16.1 | View |
| Stomatitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v16.1 | View |
| Upper gastrointestinal haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v16.1 | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v16.1 | View |
| Device malfunction | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v16.1 | View |
| Cyst | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v16.1 | View |
| Death | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v16.1 | View |
| Device breakage | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v16.1 | View |
| Device occlusion | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v16.1 | View |
| Bronchitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v16.1 | View |
| Upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v16.1 | View |
| Bronchopneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v16.1 | View |
| Dengue fever | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v16.1 | View |
| Gastroenteritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v16.1 | View |
| Gastroenteritis viral | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v16.1 | View |
| Influenza | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v16.1 | View |
| Rhinovirus infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v16.1 | View |
| Abscess neck | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v16.1 | View |
| Acute tonsillitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v16.1 | View |
| Adenovirus infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v16.1 | View |
| Amoebic dysentery | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v16.1 | View |
| Bronchiolitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v16.1 | View |
| Corona virus infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v16.1 | View |
| Device related sepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v16.1 | View |
| Diarrhoea infectious | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v16.1 | View |
| Ear infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v16.1 | View |
| Enterovirus infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v16.1 | View |
| Gastroenteritis rotavirus | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v16.1 | View |
| Gastrointestinal infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v16.1 | View |
| Helicobacter infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v16.1 | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v16.1 | View |
| Otitis media | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v16.1 | View |
| Otitis media acute | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v16.1 | View |
| Periorbital cellulitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v16.1 | View |
| Pharyngotonsillitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v16.1 | View |
| Pneumonia influenzal | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v16.1 | View |
| Pneumonia pneumococcal | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v16.1 | View |
| Pneumonia respiratory syncytial viral | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v16.1 | View |
| Pneumonia viral | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v16.1 | View |
| Pyelonephritis acute | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v16.1 | View |
| Respiratory syncytial virus infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v16.1 | View |
| Sepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v16.1 | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v16.1 | View |
| Viral infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v16.1 | View |
| Contusion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v16.1 | View |
| Clavicle fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v16.1 | View |
| Head injury | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v16.1 | View |
| Joint dislocation | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v16.1 | View |
| Lip injury | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v16.1 | View |
| Post procedural fistula | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v16.1 | View |
| Tooth fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v16.1 | View |
| Toxicity to various agents | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v16.1 | View |
| Upper limb fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v16.1 | View |
| Blood bicarbonate decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v16.1 | View |
| Liver function test abnormal | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v16.1 | View |
| Urine output decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v16.1 | View |
| Dehydration | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v16.1 | View |
| Acetonaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v16.1 | View |
| Decreased appetite | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v16.1 | View |
| Enteral feeding intolerance | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v16.1 | View |
| Hypoglycaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v16.1 | View |
| Hypophagia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v16.1 | View |
| Metabolic acidosis | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v16.1 | View |
| Muscle haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v16.1 | View |
| Convulsion | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v16.1 | View |
| Status epilepticus | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v16.1 | View |
| Epilepsy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v16.1 | View |
| Partial seizures | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v16.1 | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v16.1 | View |
| Partial seizures with secondary generalisation | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v16.1 | View |
| Febrile convulsion | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v16.1 | View |
| Hemiparesis | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v16.1 | View |
| Somnolence | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v16.1 | View |
| Altered state of consciousness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v16.1 | View |
| Cognitive disorder | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v16.1 | View |
| Grand mal convulsion | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v16.1 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v16.1 | View |
| Hypotonia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v16.1 | View |
| Intracranial haematoma | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v16.1 | View |
| Motor dysfunction | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v16.1 | View |
| Myoclonic epilepsy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v16.1 | View |
| Subdural hygroma | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v16.1 | View |
| Tonic convulsion | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v16.1 | View |
| Disorientation | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v16.1 | View |
| Emotional disorder of childhood | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v16.1 | View |
| Suicide attempt | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v16.1 | View |
| Pyuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v16.1 | View |
| Renal failure acute | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v16.1 | View |
| Vesicoureteric reflux | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v16.1 | View |
| Respiratory distress | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v16.1 | View |
| Respiratory failure | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v16.1 | View |
| Pneumonia aspiration | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v16.1 | View |
| Apnoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v16.1 | View |
| Bronchospasm | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v16.1 | View |
| Chylothorax | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v16.1 | View |
| Dyspnoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v16.1 | View |
| Epistaxis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v16.1 | View |
| Hypoventilation | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v16.1 | View |
| Hypoxia | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v16.1 | View |
| Interstitial lung disease | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v16.1 | View |
| Tonsillar hypertrophy | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v16.1 | View |
| Dermatitis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v16.1 | View |
| Drug reaction with eosinophilia and systemic symptoms | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v16.1 | View |
| Brain operation | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA v16.1 | View |
| Deep vein thrombosis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v16.1 | View |
| Hypotension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v16.1 | View |
| Dyspepsia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v16.1 | View |
| Dysphagia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v16.1 | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v16.1 | View |
| Oral herpes | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v16.1 | View |
| Idiopathic thrombocytopenic purpura | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v16.1 | View |
| Lymphadenopathy | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v16.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v16.1 | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v16.1 | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v16.1 | View |
| Upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v16.1 | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v16.1 | View |
| Pharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v16.1 | View |
| Bronchitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v16.1 | View |
| Influenza | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v16.1 | View |
| Somnolence | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v16.1 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v16.1 | View |
| Convulsion | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v16.1 | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v16.1 | View |