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 @ 4:29 AM
Ignite Modification Date: 2025-12-26 @ 3:32 AM
NCT ID: NCT04051320
Description: None
Frequency Threshold: 0
Time Frame: From Study visit 3 (intervention start) through visit 7 (Follow-Up), a total of approximately 9 weeks.
Study: NCT04051320
Study Brief: Characterizing the Neural Substrates of Irritability in Women: an Experimental Neuroendocrine Model
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Hormone Sensitive Women (HS+) Participants will take leuprolide acetate (lupron) via intramuscular injection, for 2 months. Participants will take 2 mg of estradiol twice daily and 200 mg of progesterone twice daily for 2 weeks. Leuprolide Acetate 3.75 MG/ML: 3.75 mg/month leuprolide acetate intramuscular injection Estradiol 2 Mg tablet: 2 mg estradiol tablet Micronized progesterone: 200 mg micronized progesterone tablets 0 None 0 13 12 13 View
Hormone Insensitive Women (HS-) Participants will take leuprolide acetate (lupron) via intramuscular injection, for 2 months. Participants will take 2 mg of estradiol twice daily and 200 mg of progesterone twice daily for 2 weeks. Leuprolide Acetate 3.75 MG/ML: 3.75 mg/month leuprolide acetate intramuscular injection Estradiol 2 Mg tablet: 2 mg estradiol tablet Micronized progesterone: 200 mg micronized progesterone tablets 0 None 0 10 9 10 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Bloating SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Low back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
General musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Cramps SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Headache SYSTEMATIC_ASSESSMENT General disorders None View
Migraine SYSTEMATIC_ASSESSMENT Vascular disorders None View
Occular migraine SYSTEMATIC_ASSESSMENT Vascular disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Arm soreness (Lupron IM injection) SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Arm soreness (COVID vaccine IM injection) SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Hot flashes SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Fever (COVID-19 infection) SYSTEMATIC_ASSESSMENT Infections and infestations None View
Anosmia (COVID-19 infection) SYSTEMATIC_ASSESSMENT Infections and infestations None View
COVID-19 Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Dry cough (Seasonal allergies) SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Gastrointestinal upset SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Mood swings SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Spotting SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Intrusive thoughts SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Anhedonia SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Depressed mood SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Irritability SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Concussion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Early insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Late insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Breast tenderness SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Increased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Difficulty concentrating SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Emotional sensitivity SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Heartburn SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hematoma (IM injection) SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Yeast infection SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Hormonal acne SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Hair loss SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Cervical mucus SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fever SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hip pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Frequent urination SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Vivid dreams SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Passive suicidal ideation SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Low libido SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Weight gain SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View