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 @ 11:16 PM
Ignite Modification Date: 2025-12-25 @ 8:55 PM
NCT ID: NCT05388656
Description: None
Frequency Threshold: 0
Time Frame: From the time of the first laboratory visit through final follow up visit, up to approximately 3 months.
Study: NCT05388656
Study Brief: Estrogen Variability and Irritability During the Menopause Transition
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Estradiol Participants received 0.1 mg/day of transdermal estradiol patch for 3 weeks. Estradiol Patch, 0.1 mg/24 Hours Weekly Transdermal Film, Extended Release: 0.1 mg/day transdermal patch administered for 3 weeks 0 None 0 33 18 33 View
Placebo Participants received transdermal placebo patch (matching transdermal estradiol 0.1 mg/day patch) for 3 weeks. Placebo: Estradiol-matched placebo patch administered for 3 weeks 0 None 0 31 16 31 View
Progesterone Participants received progesterone pills (1 pill per day for 10 days) after lab visit 3 (Post-Placebo and Estradiol conditions) 0 None 0 31 7 31 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Swollen Lips SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
"Bump" on vulva SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Non-migrainous headache (no visual symptoms) SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Intermittent chest pain SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Increased nausea and breast tenderness SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Irritation at patch site SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Pain in legs SYSTEMATIC_ASSESSMENT Vascular disorders None View
Numbness in fingertips SYSTEMATIC_ASSESSMENT Vascular disorders None View
Pain in right calf and swelling in legs SYSTEMATIC_ASSESSMENT Vascular disorders None View
Prolonged bleeding SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Swelling in left ankle SYSTEMATIC_ASSESSMENT Vascular disorders None View
Swelling in legs SYSTEMATIC_ASSESSMENT Vascular disorders None View
Increased breast tenderness SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Concerning breast lumps SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Migraine headache without aura SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Changes in vision/trouble with contacts SYSTEMATIC_ASSESSMENT Eye disorders None View