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 @ 4:29 AM
Ignite Modification Date:
2025-12-26 @ 3:32 AM
NCT ID:
NCT03370120
Description:
A TEAE was defined as any event that was not present prior to the initiation of the first dose of study treatment in this study or any unresolved event already present before initiation of the first dose that worsens in intensity following exposure to the treatment.
Frequency Threshold:
5
Time Frame:
From Entry Visit (Week 0) until the Safety Follow-up Visit (up to approximately 2 years)
Study:
NCT03370120
Study Brief:
Study to Test the Safety and Efficacy of Padsevonil as Adjunctive Treatment of Focal-onset Seizures in Adult Subjects With Drug-resistant Epilepsy
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Padsevonil (SS) | Participants received PSL tablets at a dose of 100 mg/day to 800 mg/day up to approximately 2 years. Participants formed the SS. | 0 | None | 48 | 406 | 184 | 406 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Inappropriate antidiuretic hormone secretion | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA v22.1 | View |
| Abdominal discomfort | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v22.1 | View |
| Large intestinal haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v22.1 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v22.1 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v22.1 | View |
| Bile duct stone | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA v22.1 | View |
| Cholecystitis | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA v22.1 | View |
| Cholelithiasis | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA v22.1 | View |
| Corona virus infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v22.1 | View |
| Cytomegalovirus infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v22.1 | View |
| Gastroenteritis viral | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v22.1 | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v22.1 | View |
| Wound infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v22.1 | View |
| Head injury | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v22.1 | View |
| Ulna fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v22.1 | View |
| Mycoplasma test positive | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v22.1 | View |
| Ovarian cancer | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v22.1 | View |
| Phyllodes tumour | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v22.1 | View |
| Cervical radiculopathy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v22.1 | View |
| Epilepsy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v22.1 | View |
| Focal dyscognitive seizures | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v22.1 | View |
| Generalised tonic-clonic seizure | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v22.1 | View |
| Migraine | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v22.1 | View |
| Partial seizures | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v22.1 | View |
| Partial seizures with secondary generalisation | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v22.1 | View |
| Postictal state | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v22.1 | View |
| Seizure | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v22.1 | View |
| Seizure cluster | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v22.1 | View |
| Status epilepticus | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v22.1 | View |
| Syncope | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v22.1 | View |
| Abortion spontaneous | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA v22.1 | View |
| Pregnancy | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA v22.1 | View |
| Aggression | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v22.1 | View |
| Suicide Attempt | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v22.1 | View |
| Acute kidney injury | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v22.1 | View |
| Pelvi-ureteric obstruction | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v22.1 | View |
| Aspiration | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v22.1 | View |
| Drug Eruption | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v22.1 | View |
| Drug reaction with eosinophilia and systemic symptoms | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v22.1 | View |
| Hip arthroplasty | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA v22.1 | View |
| Hypotension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v22.1 | View |
| Vagal nerve stimulator implantation | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA v22.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Somnolence | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v22.1 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v22.1 | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v22.1 | View |
| Memory impairment | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v22.1 | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v22.1 | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v22.1 | View |
| Insomnia | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v22.1 | View |