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 @ 4:13 PM
Ignite Modification Date: 2025-12-25 @ 2:12 PM
NCT ID: NCT03785366
Description: None
Frequency Threshold: 0
Time Frame: 5 years (60 months) for VeraCept, D57 for ParaGard
Study: NCT03785366
Study Brief: A PK Study Comparing VeraCept vs. ParaGard Intrauterine Devices (IUDs)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
VeraCept VeraCept subjects will be inserted with VeraCept on Day 1. At Day 57 subjects will be informed that they received VeraCept and may continue in the study for up to 5 years VeraCept: VeraCept Intrauterine Device (IUD) 0 None 0 20 19 20 View
ParaGard ParaGard subjects will be inserted with ParaGard on Day 1. At Day 57 subjects will be informed that they received ParaGard and may choose to have the ParaGard removed or continue use per standard of clinical care. ParaGard: ParaGard intrauterine copper contraceptive 0 None 0 19 8 19 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Pelvic pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Heavy menstrual bleeding SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Vaginal discharge SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Adnexa uteri mass SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Cervix inflammation SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Coital bleeding SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Oligomenorrhoea SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Vulvovaginal discomfort SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Vulvovaginal pruritus SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Vulvovaginal rash SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Pelvic discomfort SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Ligament sprain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Procedural pain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Post procedural discomfort SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Bell's palsy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dyspareunia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Vaginal odour SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Attention deficit hyperactivity disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Bacterial vaginosis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Vulvovaginal mycotic infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations None View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations None View
Endometritis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Herpes simplex SYSTEMATIC_ASSESSMENT Infections and infestations None View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Papilloma viral infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hypothyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Retinal detachment SYSTEMATIC_ASSESSMENT Eye disorders None View
Smear cervix abnormal SYSTEMATIC_ASSESSMENT Investigations None View
Vitamin D deficiency SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Dysarthria SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Post-traumatic headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Device expulsion SYSTEMATIC_ASSESSMENT Product Issues None View
Affect lability SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Photophobia SYSTEMATIC_ASSESSMENT Eye disorders None View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations None View
Musculoskeletal chest pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Nephrolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Ecchymosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Intermenstrual bleeding SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Dysmenorrhoea SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Post-traumatic neck syndrome SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Road traffic accident SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Amnesia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Athetosis SYSTEMATIC_ASSESSMENT Nervous system disorders None View