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 @ 2:06 AM
Ignite Modification Date:
2025-12-26 @ 12:31 AM
NCT ID:
NCT01634360
Description:
None
Frequency Threshold:
5
Time Frame:
Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
Study:
NCT01634360
Study Brief:
Long-Term Safety, Tolerability and Efficacy in Perampanel Treated Parkinson's Disease Patients With Motor Fluctuations
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Perampanel (Placebo During Core Study) | Subjects entered this open-label extension study from the double-blind core study (E2007-E044-204). Subjects started on perampanel 1mg once daily for 4 weeks, followed by 2mg once daily for 2 weeks; if they did not tolerate the 1 mg dose, subjects were withdrawn from the study. Subjects could be up-titrated to 3 or 4 mg in a sequential manner. There were at least 2 weeks between each titration to assess safety and tolerability, and the subjects attended a clinic visit for safety review and dispensing of more medication. Subjects could be down-titrated at any time to either 3, 2 or 1 mg in a sequential manner. | None | None | 13 | 48 | 3 | 48 | View |
| Perampanel (Perampanel 0.5, 1, or 2 mg During Core Study) | Subjects entered this open-label extension study from the double-blind core study (E2007-E044-204). Subjects started on perampanel 1mg once daily for 4 weeks, followed by 2mg once daily for 2 weeks; if they did not tolerate the 1 mg dose, subjects were withdrawn from the study. Subjects could be up-titrated to 3 or 4 mg in a sequential manner. There were at least 2 weeks between each titration to assess safety and tolerability, and the subjects attended a clinic visit for safety review and dispensing of more medication. Subjects could be down-titrated at any time to either 3, 2 or 1 mg in a sequential manner. | None | None | 39 | 134 | 0 | 134 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Freezing phenomenon | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 11.0 | View |
| Hyperkinesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 11.0 | View |
| Paraparesis | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 11.0 | View |
| Psycomotor hyperactivity | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 11.0 | View |
| Sciatica | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 11.0 | View |
| Transient ischemic attack | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 11.0 | View |
| Tremor | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 11.0 | View |
| Muscle rigidity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA version 11.0 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA version 11.0 | View |
| Posture abnormal | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA version 11.0 | View |
| Joint range of motion decreased | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA version 11.0 | View |
| Osteoarthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA version 11.0 | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA version 11.0 | View |
| Sensation of heaviness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA version 11.0 | View |
| Spinal column stenosis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA version 11.0 | View |
| Hallucination | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA version 11.0 | View |
| Confusional state | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA version 11.0 | View |
| Hallucination, visual | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA version 11.0 | View |
| Psychotic disorder | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA version 11.0 | View |
| Delirium | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA version 11.0 | View |
| Delusion | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA version 11.0 | View |
| Dissociation | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA version 11.0 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA version 11.0 | View |
| Hip fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 11.0 | View |
| Device malfunction | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 11.0 | View |
| Femur fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 11.0 | View |
| Head injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 11.0 | View |
| Humerous fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 11.0 | View |
| Lumbar vertebral fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 11.0 | View |
| Radial nerve injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 11.0 | View |
| Spinal fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 11.0 | View |
| Ulna fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 11.0 | View |
| Benign ovarian tumor | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 11.0 | View |
| Gastrointestinal stromal tumour | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 11.0 | View |
| Prostrate cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 11.0 | View |
| Rectal cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 11.0 | View |
| Uterine cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 11.0 | View |
| Deep vein thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA version 11.0 | View |
| Arterial stenosis limb | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA version 11.0 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA version 11.0 | View |
| Orthostatic hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA version 11.0 | View |
| Angina unstable | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA version 11.0 | View |
| Atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA version 11.0 | View |
| Cardiac failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA version 11.0 | View |
| Cardiac failure congestive | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA version 11.0 | View |
| Gait disturbance | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 11.0 | View |
| General physical health deterioration | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 11.0 | View |
| Hernia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 11.0 | View |
| Sudden death | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 11.0 | View |
| Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 11.0 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 11.0 | View |
| Blood alkaline phosphatase | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 11.0 | View |
| Blood pressure decrease | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 11.0 | View |
| Heamatocrit decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 11.0 | View |
| Investigation | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 11.0 | View |
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA version 11.0 | View |
| Epigastric discomfort | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 11.0 | View |
| Inguinal hernia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 11.0 | View |
| Obstructive uropathy | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA version 11.0 | View |
| Urinary retention | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA version 11.0 | View |
| Pulmonary embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 11.0 | View |
| Pulmonary oedema | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 11.0 | View |
| Social stay hospitalisation | SYSTEMATIC_ASSESSMENT | Social circumstances | MedDRA version 11.0 | View |
| Deep brain stimulation | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA version 11.0 | View |
| Knee arthroplasty | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA version 11.0 | View |
| Vertigo | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA version 11.0 | View |
| Cholelithiasis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA version 11.0 | View |
| Cachexia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA version 11.0 | View |
| Benign prostatic hyperplasia | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA version 11.0 | View |
| On and off phenomenon | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 11.0 | View |
| Dementia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 11.0 | View |
| Balance disorder | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 11.0 | View |
| Cerebrovascular accident | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 11.0 | View |
| Dystonia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 11.0 | View |
| Dyskinesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 11.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Muscle Rigidity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA version 11.0 | View |