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 @ 3:44 AM
Ignite Modification Date: 2025-12-26 @ 2:30 AM
NCT ID: NCT01129102
Description: None
Frequency Threshold: 5
Time Frame: From initiation of study drug to end of 6 cycle of menstrual, an average of 6 months
Study: NCT01129102
Study Brief: Efficacy and Safety Study of NPC-01 to Treat 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
NPC-01 Norethisterone 1mg, Ethinyl estradiol 0.02mg NPC-01: Norethisterone 1mg, Ethinyl estradiol 0.02mg None None 0 107 103 107 View
IKH-01 Norethisterone 1mg, Ethinyl estradiol 0.035mg IKH-01: Norethisterone 1mg, Ethinyl estradiol 0.035mg None None 1 47 45 47 View
Placebo Placebo for NPC-01 Placebo: Placebo for NPC-01 None None 0 54 44 54 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Abdominal pain lower (Dysmenorrhoea aggravated) NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA-J 13.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Breast discomfort NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA-J 13.1 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA-J 13.1 View
Cystitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA-J 13.1 View
Gastroenteritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA-J 13.1 View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA-J 13.1 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA-J 13.1 View
Abdominal discomfort NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA-J 13.1 View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA-J 13.1 View
Abdominal pain lower NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA-J 13.1 View
Abdominal pain upper NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA-J 13.1 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA-J 13.1 View
Vulvovaginal candidiasis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA-J 13.1 View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA-J 13.1 View
Musculoskeletal stiffness NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA-J 13.1 View
Hypomenorrhoea SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA-J 13.1 View
Menorrhagia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA-J 13.1 View
Metrorrhagia NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA-J 13.1 View
Oligomenorrhoea SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA-J 13.1 View
Polymenorrhoea SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA-J 13.1 View