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 @ 7:43 PM
Ignite Modification Date: 2025-12-25 @ 5:21 PM
NCT ID: NCT00152503
Description: Adverse Events refer to the Intention-To-Treat (ITT) population.
Frequency Threshold: 5
Time Frame: Adverse events were collected from Baseline to Follow-Up visit (up to Week 17).
Study: NCT00152503
Study Brief: Study With Subjects 18-65 Years Old With Partial Onset Seizures Who Are Currently Taking Levetiracetam
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. 0 None 2 59 44 59 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Angina unstable NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Skin cancer NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Convulsion NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal pain upper NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Irritability NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Bronchitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Herpes simplex NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Decreased appetite NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Convulsion NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Nystagmus NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Somnolence NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Tremor NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Dyspnoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Pharyngolaryngeal pain NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Sinus congestion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View