Adverse Events Module

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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 @ 11:57 PM
Ignite Modification Date: 2025-12-25 @ 9:54 PM
NCT ID: NCT00152451
Description: None
Frequency Threshold: 0
Time Frame: Adverse events were collected from Week 1 up to Week 17
Study: NCT00152451
Study Brief: Study With Seletracetam (Ucb 44212) in Adult Subjects (18 to 65 Years) 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
Seletracetam Escalating doses of 10, 20, 40 and 80 mg b.i.d. (twice daily) (total daily doses of 20 - 160 mg) were to be administered orally as capsules. None None 0 31 27 31 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Irritability None General disorders MedDRA View
Pyrexia None General disorders MedDRA View
Tenderness None General disorders MedDRA View
Multiple allergies None Immune system disorders MedDRA View
Ear infection None Infections and infestations MedDRA View
Nasopharyngitis None Infections and infestations MedDRA View
Rhinitis None Infections and infestations MedDRA View
Upper respiratory tract infection None Infections and infestations MedDRA View
Urinary tract infection None Infections and infestations MedDRA View
Vaginal infection None Infections and infestations MedDRA View
Viral infection None Infections and infestations MedDRA View
Anticonvulsant toxicity None Injury, poisoning and procedural complications MedDRA View
Arthropod sting None Injury, poisoning and procedural complications MedDRA View
Chest injury None Injury, poisoning and procedural complications MedDRA View
Contusion None Injury, poisoning and procedural complications MedDRA View
Fall None Injury, poisoning and procedural complications MedDRA View
Scratch None Injury, poisoning and procedural complications MedDRA View
Tongue injury None Injury, poisoning and procedural complications MedDRA View
Tooth injury None Injury, poisoning and procedural complications MedDRA View
Alanine aminotransferase increased None Investigations MedDRA View
Aspartate aminotransferase increased None Investigations MedDRA View
Blood creatine phosphokinase increased None Investigations MedDRA View
Blood thyroid stimulating hormone increased None Investigations MedDRA View
Gamma-glutamyltransferase increased None Investigations MedDRA View
Liver function test abnormal None Investigations MedDRA View
Platelet count decreased None Investigations MedDRA View
Positive Rombergism None Investigations MedDRA View
Red blood cell morphology abnormal None Investigations MedDRA View
Urine analysis abnormal None Investigations MedDRA View
Anorexia None Metabolism and nutrition disorders MedDRA View
Decreased appetite None Metabolism and nutrition disorders MedDRA View
Hyponatraemia None Metabolism and nutrition disorders MedDRA View
Arthralgia None Musculoskeletal and connective tissue disorders MedDRA View
Back pain None Musculoskeletal and connective tissue disorders MedDRA View
Convulsion None Nervous system disorders MedDRA View
Coordination abnormal None Nervous system disorders MedDRA View
Dizziness None Nervous system disorders MedDRA View
Headache None Nervous system disorders MedDRA View
Hypersomnia None Nervous system disorders MedDRA View
Migraine None Nervous system disorders MedDRA View
Nystagmus None Nervous system disorders MedDRA View
Sensory disturbance None Nervous system disorders MedDRA View
Sinus headache None Nervous system disorders MedDRA View
Somnolence None Nervous system disorders MedDRA View
Tremor None Nervous system disorders MedDRA View
Anxiety None Psychiatric disorders MedDRA View
Confusional state None Psychiatric disorders MedDRA View
Crying None Psychiatric disorders MedDRA View
Depressed mood None Psychiatric disorders MedDRA View
Depression None Psychiatric disorders MedDRA View
Emotional disorder None Psychiatric disorders MedDRA View
Insomnia None Psychiatric disorders MedDRA View
Nervousness None Psychiatric disorders MedDRA View
Paranoia None Psychiatric disorders MedDRA View
Nasal congestion None Respiratory, thoracic and mediastinal disorders MedDRA View
Respiratory tract congestion None Respiratory, thoracic and mediastinal disorders MedDRA View
Sinus congestion None Respiratory, thoracic and mediastinal disorders MedDRA View
Blister None Skin and subcutaneous tissue disorders MedDRA View
Dry skin None Skin and subcutaneous tissue disorders MedDRA View
Rash maculo-papular None Skin and subcutaneous tissue disorders MedDRA View
Poor venous access None Vascular disorders MedDRA View
Fatigue None General disorders MedDRA View
Gait disturbance None General disorders MedDRA View
Sinus bradycardia None Cardiac disorders MedDRA View
Motion sickness None Ear and labyrinth disorders MedDRA View
Tinnitus None Ear and labyrinth disorders MedDRA View
Eye irritation None Eye disorders MedDRA View
Abdominal pain lower None Gastrointestinal disorders MedDRA View
Abdominal tenderness None Gastrointestinal disorders MedDRA View
Constipation None Gastrointestinal disorders MedDRA View
Diarrhoea None Gastrointestinal disorders MedDRA View
Gastrooesophageal reflux disease None Gastrointestinal disorders MedDRA View
Nausea None Gastrointestinal disorders MedDRA View
Stomach discomfort None Gastrointestinal disorders MedDRA View
Asthenia None General disorders MedDRA View
Energy increased None General disorders MedDRA View