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 @ 9:07 PM
Ignite Modification Date: 2025-12-25 @ 6:58 PM
NCT ID: NCT01723904
Description: Adverse Events refer to the Saftey Set. Safety Set consists of all subjects who were enrolled and had at least 1 patch applied during the Treatment Period.
Frequency Threshold: 5
Time Frame: Adverse Events (AEs) were collected over the whole study duration from the Screening Period (Day -28 to Day -7) to the Safety Follow-up Visit (up to Day 78).
Study: NCT01723904
Study Brief: A Phase 3b, Open-Label, Safety and Efficacy Study of Rotigotine as Add-On Therapy With Low Doses of Pramipexole or Ropinirole in Patients With Advanced Parkinson's Disease
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 \- Titration Period: Weekly titration to the subject's optimal dose of Rotigotine between 2 mg/24 h and 8 mg/24 h. In case of intolerable Adverse Events (AEs) one back-titration is allowed during the Titration Period. Duration of the Titration Period: Between 1 week and 5 weeks. \- Maintenance Period: Starts once subject reached either optimal or maximal dose of Rotigotine. Subjects receive stable dose of Rotigotine throughout the Maintenance Period. No back-titration is allowed during the Maintenance Period. Duration of the Maintenance Period: Between 3 weeks and 7 weeks. Rotigotine: Application of Rotigotine up to 8 mg/24 h patches for 24 hours. None None 5 90 35 90 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Nasopharyngeal cancer NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 16.0 View
Hallucination NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 16.0 View
Urinary retention NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 16.0 View
Subdural haemorrhage NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 16.0 View
Confusional state NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 16.0 View
Delirium NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 16.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16.0 View
Application site pruritus NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 16.0 View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16.0 View
Dyskinesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16.0 View
Orthostatic hypotension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 16.0 View