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 @ 1:24 AM
Ignite Modification Date: 2025-12-25 @ 11:33 PM
NCT ID: NCT00687193
Description: The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Frequency Threshold: 2
Time Frame: None
Study: NCT00687193
Study Brief: Comparison Of 5 CP-690,550 Doses Vs. Placebo, For The Treatment Of Rheumatoid Arthritis In Japan
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
CP-690,550 1 mg Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks. None None 0 53 14 53 View
CP-690,550 3 mg Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks. None None 3 53 16 53 View
CP-690,550 5 mg Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks. None None 2 52 19 52 View
CP-690,550 10 mg Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks. None None 2 53 22 53 View
CP-690,550 15 mg Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks. None None 1 54 22 54 View
Placebo Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks. None None 1 52 16 52 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Gastric ulcer perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Herpes zoster SYSTEMATIC_ASSESSMENT Infections and infestations None View
Herpes zoster oticus SYSTEMATIC_ASSESSMENT Infections and infestations None View
Fibula fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Spinal compression fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Tendon rupture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Tibia fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
Blood creatine phosphokinase increased SYSTEMATIC_ASSESSMENT Investigations None View
Post herpetic neuralgia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Atelectasis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Rheumatoid vasculitis SYSTEMATIC_ASSESSMENT Vascular disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dental caries SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gingivitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Bronchitis None Infections and infestations None View
Herpes zoster SYSTEMATIC_ASSESSMENT Infections and infestations None View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
Blood cholesterol increased SYSTEMATIC_ASSESSMENT Investigations None View
Low density lipoprotein increased SYSTEMATIC_ASSESSMENT Investigations None View
Hypercholesterolaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyperlipidaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Rheumatoid arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Upper respiratory tract inflammation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View