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 @ 7:07 PM
Ignite Modification Date: 2025-12-25 @ 4:41 PM
NCT ID: NCT00909857
Description: None
Frequency Threshold: 2
Time Frame: None
Study: NCT00909857
Study Brief: Effect on Primary Dysmenorrhea
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles None None 2 234 131 234 View
Ethinyl Estradiol, Levonorgestrel (Miranova) Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles None None 2 230 122 230 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Helminthic infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (13.1) View
Animal bite NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (13.1) View
Depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (13.1) View
Ovarian torsion NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA (13.1) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dental caries NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (13.1) View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (13.1) View
Inflammation NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (13.1) View
Influenza NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (13.1) View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (13.1) View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (13.1) View
Tension headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (13.1) View
Cervical dysplasia NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA (13.1) View
Dysfunctional uterine bleeding NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA (13.1) View
Dysmenorrhoea NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA (13.1) View
Metrorrhagia NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA (13.1) View
Cervix inflammation NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA (13.1) View