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 @ 1:33 AM
Ignite Modification Date: 2025-12-25 @ 11:46 PM
NCT ID: NCT00881894
Description: Adverse events are reported for the Safety Set (SS). The SS includes all randomized subjects who received at least 1 dose of trial medication (N=52). Two subjects terminated the study prematurely after period 1 (1 subject in sequence A-B and 1 in sequence B-A). Therefore the number of subject exposed to each treatment is N=51.
Frequency Threshold: 0
Time Frame: Adverse Events (AEs) were collected within 48 hours.
Study: NCT00881894
Study Brief: Study in Healthy Volunteers to Prove That 2 Rotigotine Patches From Different Manufacturing Processes Deliver Equivalent Drug Amount to the Body.
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Treatment A (Test: PR2.1.1) Rotigotine transdermal patch (4.5 mg/ 10 cm\^2) from modified manufacturing process (Test; drug product PR2.1.1); single application of 1 patch for 24 hours None None 0 51 21 51 View
Treatment B (Reference: PR1.0) Rotigotine transdermal patch (4.5 mg/ 10 cm\^2) from originally approved manufacturing process (Reference; drug product PR1.0); single application of 1 patch for 24 hours None None 0 51 21 51 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abnormal Sensation in Eye NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (9.1) View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (9.1) View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (9.1) View
Application Site Pruritus NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (9.1) View
Application Site Cold Feeling NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (9.1) View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (9.1) View
Rhinitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (9.1) View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (9.1) View
Somnolence NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (9.1) View
Syncope Vasovagal NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (9.1) View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (9.1) View
Disturbance in Attention NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (9.1) View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (9.1) View
Hyperhidrosis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (9.1) View