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 @ 4:55 AM
Ignite Modification Date: 2025-12-26 @ 3:55 AM
NCT ID: NCT01483118
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT01483118
Study Brief: Cinnamon Extract on Menstrual Cycles in PolyCystic Ovary Syndrome (PCOS)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Cinnamon Extract Arm PCOS patients receiving extract of cinnamon Cinnamon Extract: Purified aqueous abstract of cinnamon in 125mg capsules, which would be taken orally before each meal, for a total of 1,500mg/day for 6 months. None None 1 23 15 23 View
Placebo Arm PCOS patients receiving placebo capsules Placebo: Placebo capsules containing ground cereal. None None 0 22 13 22 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Right leg swelling with pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Menstrual cramps NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Overdose NON_SYSTEMATIC_ASSESSMENT General disorders None View
Pregnancy NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Itchy rash NON_SYSTEMATIC_ASSESSMENT General disorders None View
Alopecia NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Gastroenteritis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Enlarged breast NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Miscarriage NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Swelling of face (cheeks) NON_SYSTEMATIC_ASSESSMENT General disorders None View
Swelling of feet and hands NON_SYSTEMATIC_ASSESSMENT General disorders None View
Acid reflux NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Anxiety NON_SYSTEMATIC_ASSESSMENT General disorders None View
Back pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Bodyache NON_SYSTEMATIC_ASSESSMENT General disorders None View
Breast tenderness NON_SYSTEMATIC_ASSESSMENT General disorders None View
Bruise on thigh NON_SYSTEMATIC_ASSESSMENT General disorders None View
Bunion NON_SYSTEMATIC_ASSESSMENT General disorders None View
Chest pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Cold NON_SYSTEMATIC_ASSESSMENT General disorders None View
Congestion NON_SYSTEMATIC_ASSESSMENT General disorders None View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Feet swelling NON_SYSTEMATIC_ASSESSMENT General disorders None View
Hands/palms swelling NON_SYSTEMATIC_ASSESSMENT General disorders None View
Hangover NON_SYSTEMATIC_ASSESSMENT General disorders None View
Headache NON_SYSTEMATIC_ASSESSMENT General disorders None View
Heartburn NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Heightened sense of smell NON_SYSTEMATIC_ASSESSMENT General disorders None View
Insomnia NON_SYSTEMATIC_ASSESSMENT General disorders None View
Joint pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Lightheadedness NON_SYSTEMATIC_ASSESSMENT General disorders None View
Migraine NON_SYSTEMATIC_ASSESSMENT General disorders None View
Nasal congestion NON_SYSTEMATIC_ASSESSMENT General disorders None View
Nausea NON_SYSTEMATIC_ASSESSMENT General disorders None View
Pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Pink eye NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Sleep problem NON_SYSTEMATIC_ASSESSMENT General disorders None View
Sleepiness NON_SYSTEMATIC_ASSESSMENT General disorders None View
Sore throat NON_SYSTEMATIC_ASSESSMENT General disorders None View
Stomachache NON_SYSTEMATIC_ASSESSMENT General disorders None View
Stomach cramps NON_SYSTEMATIC_ASSESSMENT General disorders None View
Stye in eye NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Swelling of lips NON_SYSTEMATIC_ASSESSMENT General disorders None View
Swelling/puffiness of eye area NON_SYSTEMATIC_ASSESSMENT General disorders None View
Throat/nasal congestion NON_SYSTEMATIC_ASSESSMENT General disorders None View
Tiredness NON_SYSTEMATIC_ASSESSMENT General disorders None View
Toothache NON_SYSTEMATIC_ASSESSMENT General disorders None View
Trouble falling asleep NON_SYSTEMATIC_ASSESSMENT General disorders None View
Upset stomach NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View