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: 2025-12-26 @ 11:47 AM
Ignite Modification Date: 2025-12-26 @ 11:47 AM
NCT ID: NCT03502616
Description: Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).
Frequency Threshold: 5
Time Frame: For the first 2 arms: (tofacitinib and Placebo [up to Week 16]): Baseline to Week 16 and for the next 2 arms (tofacitinib and placebo then tofacitinib [Day 1 to Week 48]): Baseline to Week 48
Study: NCT03502616
Study Brief: Efficacy and Safety of Tofacitinib in Subjects With Active Ankylosing Spondylitis (AS)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Tofacitinib: Up to Week 16 Participants received tofacitinib 5 mg tablets twice daily for 16 weeks. 0 None 2 133 23 133 View
Placebo: Up to Week 16 Participants received tofacitinib matching placebo tablets, twice daily for 16 weeks. 0 None 1 136 26 136 View
Tofacitinib: Day 1 to Week 48 Participants received tofacitinib 5 mg tablets twice daily for 48 weeks. 0 None 7 133 51 133 View
Placebo Then Tofacitinib: Day 1 to Week 48 Participants received tofacitinib matching placebo tablets, twice daily for 16 weeks followed by tofacitinib tablets 5 mg, twice daily for next 32 weeks (i.e. up to Week 48). 0 None 2 136 52 136 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hypoacusis NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA v.23.0 View
Abdominal adhesions NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v.23.0 View
Meningitis aseptic NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v.23.0 View
Rib fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v.23.0 View
Hyperplastic cholecystopathy NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA v.23.0 View
Spinal osteoarthritis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v.23.0 View
Migraine NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v.23.0 View
Ureterolithiasis NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA v.23.0 View
Pneumothorax NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v.23.0 View
Subcutaneous emphysema NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v.23.0 View
Condition aggravated NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v.23.0 View
Thoracic vertebral fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v.23.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v.23.0 View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v.23.0 View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v.23.0 View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v.23.0 View
Alanine aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA v.23.0 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v.23.0 View
Abdominal pain upper NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v.23.0 View
Protein urine present NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA v.23.0 View