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: 2025-12-25 @ 12:20 AM
Ignite Modification Date: 2025-12-25 @ 10:24 PM
NCT ID: NCT00474058
Description: Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who are randomized and received at least one dose of trial medication.
Frequency Threshold: 5
Time Frame: Adverse Events (AEs) were collected up to 22 weeks from Visit 1 to the Safety Follow- Up Visit.
Study: NCT00474058
Study Brief: Randomized Evaluation of the 24-Hour Coverage: Efficacy of Rotigotine
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Rotigotine Rotigotine transdermal patch None None 10 191 70 191 View
Placebo Placebo transdermal patch None None 5 96 21 96 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (9.1) View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA (9.1) View
Cholecystitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA (9.1) View
Urosepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (9.1) View
Ankle fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (9.1) View
Intervertebral disc protrusion SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (9.1) View
Chronic lymphocytic leukaemia SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (9.1) View
Basal cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (9.1) View
Cerebrovascular accident SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (9.1) View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (9.1) View
Abortion SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA (9.1) View
Panic attack SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (9.1) View
Completed suicide SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (9.1) View
Hallucination, visual SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (9.1) View
Sleep attacks SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (9.1) View
Nephrotic syndrome SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (9.1) View
Renal impairment SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (9.1) View
Benign prostatic hyperplasia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA (9.1) View
Pneumonia aspiration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (9.1) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (9.1) View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (9.1) View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (9.1) View
Dyskinesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (9.1) View