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 @ 3:30 AM
Ignite Modification Date: 2025-12-26 @ 2:11 AM
NCT ID: NCT00881205
Description: The safety population will consist of all patients that received at least one dose of study drug and had at least one post-baseline safety assessment. Patients will be analyzed according to treatment received.
Frequency Threshold: 3
Time Frame: None
Study: NCT00881205
Study Brief: Rivastigmine in Multiple Sclerosis Patients With Cognitive Impairment
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Rivastigmine Rivastigmine patch arm with the application of one 5 cm² patch, followed by an increase to the target dose of 10 cm² patch size None None 2 45 25 45 View
Placebo Placebo patch arm with the application of one 5 cm² patch, followed by an increase to the target dose of 10 cm² patch size None None 4 41 23 41 View
Total Patients Total Patients None None 6 86 48 86 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
PYREXIA SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.0 View
OPTIC NEURITIS SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.0 View
NAUSEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
OEDEMA PERIPHERAL SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.0 View
CELLULITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
PYELONEPHRITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
SEPSIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
DIZZINESS SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.0 View
DEPRESSION SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 14.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
VERTIGO SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 14.0 View
DIARRHOEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
NAUSEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
CHILLS SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.0 View
INFLUENZA LIKE ILLNESS SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.0 View
RESPIRATORY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
MUSCLE SPASMS SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 14.0 View
DIZZINESS SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.0 View
DEPRESSION SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 14.0 View
COUGH SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 14.0 View
ERYTHEMA SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 14.0 View
RASH SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 14.0 View
SKIN IRRITATION SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 14.0 View
HYPERTENSION SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 14.0 View
VOMITING SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
NASOPHARYNGITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
MULTIPLE SCLEROSIS RELAPSE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.0 View
PRURITUS SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 14.0 View
SKIN REACTION SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 14.0 View