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 @ 11:16 PM
Ignite Modification Date:
2025-12-25 @ 8:54 PM
NCT ID:
NCT01398956
Description:
Advers events refers to the Safety Set (SS) which consisted of all subjects who took at least one dose of study medication in this study.
Frequency Threshold:
5
Time Frame:
Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (up to 4.7 years).
Study:
NCT01398956
Study Brief:
An Open Label Study of L059 (Levetiracetam) in Japanese Epilepsy Subjects With Generalized Tonic-clonic 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 |
|---|---|---|---|---|---|---|---|---|
| Levetiracetam (SS) | Levetiracetam dose was be adjusted at the investigator's discretion in the range from 20mg/kg/day or 1000mg/day to 60mg/kg/day or 3000mg/day during this study | None | None | 13 | 44 | 41 | 44 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Influenza | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA17.0 | View |
| Acute tonsillitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA17.0 | View |
| Bronchitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA17.0 | View |
| Bronchopneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA17.0 | View |
| Pharyngotonsillitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA17.0 | View |
| Pneumonia respiratory syncytial viral | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA17.0 | View |
| Postoperative wound infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA17.0 | View |
| Cervical vertebral fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA17.0 | View |
| Femoral neck fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA17.0 | View |
| Medical observation | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA17.0 | View |
| Fracture malunion | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA17.0 | View |
| Torticollis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA17.0 | View |
| Breast adenoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA17.0 | View |
| Convulsion | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA17.0 | View |
| Epilepsy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA17.0 | View |
| Monoplegia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA17.0 | View |
| Prostatitis | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA17.0 | View |
| Sleep apnoea syndrome | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA17.0 | View |
| Status asthmaticus | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA17.0 | View |
| Abortion induced | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA17.0 | View |
| Scoliosis surgery | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA17.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Dental caries | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA17.0 | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA17.0 | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA17.0 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA17.0 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA17.0 | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA17.0 | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA17.0 | View |
| Influenza | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA17.0 | View |
| Otitis media | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA17.0 | View |
| Gastroenteritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA17.0 | View |
| Bronchitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA17.0 | View |
| Conjunctivitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA17.0 | View |
| Pulpitis dental | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA17.0 | View |
| Contusion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA17.0 | View |
| Excoriation | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA17.0 | View |
| Wound | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA17.0 | View |
| Weight increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA17.0 | View |
| Electrocardiogram QT prolonged | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA17.0 | View |
| Protein urine present | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA17.0 | View |
| Pain in extremity | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA17.0 | View |
| Arthralgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA17.0 | View |
| Convulsion | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA17.0 | View |
| Somnolence | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA17.0 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA17.0 | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA17.0 | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA17.0 | View |
| Rhinitis allergic | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA17.0 | View |
| Eczema | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA17.0 | View |
| Skin erosion | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA17.0 | View |