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 @ 11:33 PM
Ignite Modification Date: 2025-12-25 @ 9:22 PM
NCT ID: NCT01044056
Description: None
Frequency Threshold: 5
Time Frame: 21 days
Study: NCT01044056
Study Brief: A Trial in Healthy Female Subjects to Compare the Pharmacokinetics of Ethinyl Estradiol of NuvaRing®, a Contraceptive Patch (EVRA(TM)) and an Oral Contraceptive (Microgynon® 30) (Study 34237 (P06650)) (COMPLETED)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Levonorgestrel/Ethinylestradiol Oral Contraceptive Tablets Levonorgestrel (LNG)/ethinylestradiol (EE) oral contraceptive tablets (Microgynon(R) 30), 21 in total, containing 0.150 mg LNG and 0.030 EE per tablet administered once daily orally for 21 consecutive days. None None 0 8 5 8 View
Norelgestrominum and Ethinylestradiol Contraceptive Patch A contraceptive patch (EVRA(TM), one patch for 7 days for three consecutive weeks, 3 patches in total, applied on the lower abdomen. Dose: per patch 6 mg norelgetromin and 0.750 mg EE releasing 0.150 mg norelegestromin and 0.020 mg EE per day. None None 0 8 8 8 View
Etonogestrel and Ethinylestradiol Contraceptive Vaginal Ring Nuvaring(R), one nring for a period of 21 days, inserted vaginally. Dose: per ring 11.7 mg etonrgestrel (ENG) and 2.7 mg EE releasing a daily average amount of 0.120 mg etonorgestrel and 0.015 mg EE None None 0 8 8 8 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
DYSURIA SYSTEMATIC_ASSESSMENT Renal and urinary disorders 7 View
ABDOMINAL PAIN SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 7 View
DRY MOUTH SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 7 View
FLATULENCE SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 7 View
LOOSE STOOLS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 7 View
NAUSEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 7 View
VOMITING SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 7 View
APPLICATION SITE DERMATITIS SYSTEMATIC_ASSESSMENT General disorders 7 View
APPLICATION SITE IRRITATION SYSTEMATIC_ASSESSMENT General disorders 7 View
APPLICATION SITE PRURITUS SYSTEMATIC_ASSESSMENT General disorders 7 View
FATIGUE SYSTEMATIC_ASSESSMENT General disorders 7 View
OEDEMA PERIPHERAL SYSTEMATIC_ASSESSMENT General disorders 7 View
VENIPUNCTURE SITE PAIN SYSTEMATIC_ASSESSMENT General disorders 7 View
SEASONAL ALLERGY SYSTEMATIC_ASSESSMENT Immune system disorders 7 View
NASOPHARYNGITIS SYSTEMATIC_ASSESSMENT Infections and infestations 7 View
UPPER RESPIRATORY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations 7 View
ANIMAL SCRATCH SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications 7 View
ARTHROPOD BITE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications 7 View
CONTUSION SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications 7 View
FALL SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications 7 View
MUSCLE STRAIN SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications 7 View
SKIN LACERATION SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications 7 View
BACK PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 7 View
MYALGIA SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 7 View
DIZZINESS SYSTEMATIC_ASSESSMENT Nervous system disorders 7 View
HEADACHE SYSTEMATIC_ASSESSMENT Nervous system disorders 7 View
SYNCOPE VASOVAGAL SYSTEMATIC_ASSESSMENT Nervous system disorders 7 View
MOOD ALTERED SYSTEMATIC_ASSESSMENT Psychiatric disorders 7 View
URINE ODOUR ABNORMAL SYSTEMATIC_ASSESSMENT Renal and urinary disorders 7 View
BREAST TENDERNESS SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders 7 View
DYSMENORRHOEA SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders 7 View
GENITAL PAIN SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders 7 View
MENORRHAGIA SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders 7 View
PELVIC PAIN SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders 7 View
VAGINAL DISCHARGE SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders 7 View
VAGINAL HAEMORRHAGE SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders 7 View
PHARYNGOLARYNGEAL PAIN SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 7 View
RHINORRHOEA SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 7 View
ACNE SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 7 View
ERYTHEMA NODOSUM SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 7 View
INGROWING NAIL SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 7 View