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 @ 3:30 AM
Ignite Modification Date: 2025-12-26 @ 2:12 AM
NCT ID: NCT03243305
Description: An AE was defined as any unfavorable and unintended sign (including abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug, whether or not it is considered related.
Frequency Threshold: 2
Time Frame: 10 months
Study: NCT03243305
Study Brief: AMP002 Phase III Contraceptive Study
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Interventional This is a single-arm, open-label, Phase III study of AMPHORA, a non-hormonal contraceptive, at 112 sites in the United States (US) over seven cycles of use in women aged 18 to 35 years who are at risk of pregnancy. AMPHORA: non-hormonal contraceptive vaginal gel 0 None 17 1330 601 1330 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 21.0 View
Dehydration NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA Version 21.0 View
Depression suicidal NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA Version 21.0 View
Peritoneal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 21.0 View
Cholelithiasis NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA Version 21.0 View
Cystitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 21.0 View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 21.0 View
Sepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 21.0 View
Uterine rupture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA Version 21.0 View
Hodgkin's disease NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA Version 21.0 View
Status epilepticus NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 21.0 View
Premature separation of placenta NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA Version 21.0 View
Alcohol withdrawal syndrome NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA Version 21.0 View
Bipolar I disorder NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA Version 21.0 View
Vaginal disorder NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA Version 21.0 View
Trisomy 21 NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA Version 21.0 View
Preeclampsia NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA Version 21.0 View
Premature rupture of membrane NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA Version 21.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Bacterial vaginosis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 21.0 View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 21.0 View
Vulvovaginal mycotic infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 21.0 View
Vulvovaginal burning sensation NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA Version 21.0 View
Vulvovaginal pain NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA Version 21.0 View
Vulvovaginal pruritus NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA Version 21.0 View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 21.0 View