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 @ 7:32 PM
Ignite Modification Date: 2025-12-25 @ 5:14 PM
NCT ID: NCT00214903
Description: Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up.
Frequency Threshold: 5
Time Frame: Information on adverse events was collected over a time period of 8.5 years.
Study: NCT00214903
Study Brief: European Active Surveillance Study of Women Taking Hormone Replacement Therapy (HRT)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
DRSP/E2 Users of oral continuous combined preparations containing 2mg DRSP and 1mg estradiol None None 707 10043 0 10043 View
ooccHRT Users of other oral continuous combined HRT preparations containing other progestogens None None 1998 13384 0 13384 View
ooHRT Users of oral but not continuous combined HRT preparations None None 576 4113 0 4113 View
Non-oral HRT Users of non-oral HRT preparations None None 508 3057 0 3057 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Infectious diseases SYSTEMATIC_ASSESSMENT Infections and infestations ICD-10 View
Neoplasms, malignant and benign SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) ICD-10 View
Diseases of the blood and bloodforming organs SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders ICD-10 View
Endocrine diseases SYSTEMATIC_ASSESSMENT Endocrine disorders ICD-10 View
Psychiatric and neurological disorders SYSTEMATIC_ASSESSMENT Psychiatric disorders ICD-10 View
Eye SYSTEMATIC_ASSESSMENT Eye disorders ICD-10 View
Ear SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders ICD-10 View
Cardiovascular system SYSTEMATIC_ASSESSMENT Cardiac disorders ICD-10 View
Respiratory system SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders ICD-10 View
Digestive system SYSTEMATIC_ASSESSMENT Gastrointestinal disorders ICD-10 View
Skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders ICD-10 View
Injury, poisoning, accidents, etc. SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications ICD-10 View
Muscoskeletal system & connective tissue SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders ICD-10 View
Genitourinary system SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders ICD-10 View
Other Events(If Any):