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 @ 9:16 PM
Ignite Modification Date: 2025-12-25 @ 7:05 PM
NCT ID: NCT00451204
Description: An adverse event is any condition that occurs after enrollment, whether or not considered related to study treatment.
Frequency Threshold: 0
Time Frame: After enrollment, during the 24-month treatment period
Study: NCT00451204
Study Brief: A Combination Trial of Copaxone Plus Estriol in Relapsing Remitting Multiple Sclerosis (RRMS)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Estriol Capsules Plus Copaxone Injections Estriol: Estriol 8 mg capsule, once per day, duration of treatment is 2 years None None 8 82 76 82 View
Placebo Capsules Plus Copaxone Injections Placebo: Placebo capsule, once a day, treatment duration is 2 years None None 10 76 67 76 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
MS Relapse (hospitalization) SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Pregnancy SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Migraine headache related eye pain SYSTEMATIC_ASSESSMENT Eye disorders None View
Heart Failure/ pace maker implantation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pyelonephritis SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Accidentally took other's drug SYSTEMATIC_ASSESSMENT Investigations None View
Acute appendicitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
B-cell lymphoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
car accident related body numbness SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Right Knee Replacemebt SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Upper respiratory Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
GA injection area abnormalities SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Irregular menses/ spotting SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Urinary tract infection SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Depression/ Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Menstrual flow amount increased SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Headache SYSTEMATIC_ASSESSMENT General disorders None View
Nausea/ vomitting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
GA injection systemic reaction (SOB, hot flashes) SYSTEMATIC_ASSESSMENT General disorders None View
Sinusitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Arm/ leg numbness, tingling SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Gastroenteritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Vision problem (blurry, double) SYSTEMATIC_ASSESSMENT Eye disorders None View
Back Pain SYSTEMATIC_ASSESSMENT General disorders None View
Menstrual cramp SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Insomnia SYSTEMATIC_ASSESSMENT General disorders None View
Heart palpitation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Shingles SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Vaginal infection SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Uterus, endometrial thickness > 8mm (ultrasound) SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Uterus, endometrial biopsies performed SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Uterus, fibroibds (ultrasound) SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Fibrocystic disease on clinical exam SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View