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 @ 6:54 PM
Ignite Modification Date: 2025-12-25 @ 4:27 PM
NCT ID: NCT03034057
Description: The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Frequency Threshold: 5
Time Frame: Up to 1 year
Study: NCT03034057
Study Brief: Sayana Press UK Self-Injection 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
Sayana Press Following product use education and a supervised initial self-injection at the baseline visit, participants self-injected Sayana Press in the home setting every 3 months (at Month 3, Month 6 and Month 9) and returned for a final study visit at Month 12. 0 None 5 169 60 169 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Food poisoning NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA21.1 View
Mastitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA21.1 View
Ovarian germ cell teratoma benign NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA21.1 View
Cauda equina syndrome NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA21.1 View
Cervical dysplasia NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA21.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Injection site bruising NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA21.1 View
Injection site mass NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA21.1 View
Injection site pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA21.1 View
Depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA21.1 View
Vaginal haemorrhage NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA21.1 View