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 @ 11:45 PM
Ignite Modification Date: 2025-12-25 @ 9:38 PM
NCT ID: NCT01458951
Description: The same event may appear as both an adverse event (AE) and an serious adverse event (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.
Frequency Threshold: 5
Time Frame: Baseline up to Day 98
Study: NCT01458951
Study Brief: A Study To Evaluate Both The Efficacy and Safety Profile of CP-690,550 In Patients With Moderately to Severely Active Ulcerative Colitis
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 10 mg BID Participants received tofacitinib 10 mg tablets, orally, BID for 9 weeks of double blind treatment period. None None 18 429 68 429 View
Tofacitinib 15 mg BID Participants received tofacitinib 15 mg tablets, orally, BID for 9 weeks of double blind treatment period. None None 0 6 4 6 View
Placebo BID Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period. None None 9 112 20 112 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA v.18.0 View
Cardiac failure congestive NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v.18.0 View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v.18.0 View
Anal fistula NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v.18.0 View
Colitis ulcerative NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v.18.0 View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v.18.0 View
Crohn's disease NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v.18.0 View
Intestinal perforation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v.18.0 View
Proctalgia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v.18.0 View
Asthenia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v.18.0 View
Chills NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v.18.0 View
Furuncle NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v.18.0 View
Femur fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v.18.0 View
Hip fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v.18.0 View
Dehydration NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v.18.0 View
Colon adenoma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA v.18.0 View
Colon neoplasm NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA v.18.0 View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA v.18.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA v.18.0 View
Contusion NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v.18.0 View
Hypercholesterolaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v.18.0 View
Hypertriglyceridaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v.18.0 View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v.18.0 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v.18.0 View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v.18.0 View
Abdominal pain upper NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v.18.0 View
Vulvovaginal candidiasis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v.18.0 View
Urine analysis abnormal NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA v.18.0 View