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 @ 4:30 AM
Ignite Modification Date: 2025-12-26 @ 3:32 AM
NCT ID: NCT03933618
Description: The 6 arms are comprised of certain orders of drug administration. To maintain the integrity of this order, AE have been listed as part of the arm it belongs to. Details regarding when the AE occurred in relation to the drug being administered at that point in time during the arm is listed at the bottom of the table.
Frequency Threshold: 0
Time Frame: Adverse events were collected after the first dose of medication and at the end of week 8, week 16, and week 24 at a participant and provider meeting.
Study: NCT03933618
Study Brief: Anastrazole and Clomiphene to Evaluate Hypogonadal Symptoms and Erectile Function
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Anastrazole-clomiphene-placebo anastrozole for eight weeks then clomiphene for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap 0 None 0 4 2 4 View
Anastrazole-placebo-clomiphene anastrozole for eight weeks then placebo for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap 0 None 0 4 1 4 View
Clomiphene-anastrazole-placebo clomiphene for eight weeks then anastrozole for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap 0 None 0 4 1 4 View
Clomiphene-placebo-anastrazole clomiphene for eight weeks then placebo for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap 0 None 0 4 1 4 View
Placebo-clomiphene-anastrazole placebo for eight weeks then clomiphene for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap 0 None 1 4 1 4 View
Placebo-anastrazole-clomiphene placebo for eight weeks then anastrozole for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap 0 None 0 4 3 4 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Lyme Disease SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache SYSTEMATIC_ASSESSMENT General disorders None View
Osteopenia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Rib Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Left Shoulder Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Upper Respiratory Infection (URI) SYSTEMATIC_ASSESSMENT Infections and infestations None View
Vitamin D deficiency SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Insomnia SYSTEMATIC_ASSESSMENT General disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Weight Gain SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Decreased Libido SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Chronic Maxillary Sinusitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Right Big Toe Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Ringworm SYSTEMATIC_ASSESSMENT Infections and infestations None View
Nasal Septal Deviation SYSTEMATIC_ASSESSMENT General disorders None View
Bloated SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View