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 @ 4:32 AM
Ignite Modification Date: 2025-12-26 @ 3:34 AM
NCT ID: NCT01345318
Description: The same event might have appeared as both an AE and a 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 might have experienced both a serious and non-serious event during the study.
Frequency Threshold: 5
Time Frame: None
Study: NCT01345318
Study Brief: B0151005 Open-Label Extension Study
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
PF-04236921 All participants entering this study were given a 50 mg SC dose of PF-04236921 at baseline and then every 8 weeks through Week 40. The participants were on active treatment through Week 48. A one-time dose escalation to 100 mg was allowed, if participants experienced a clinical deterioration or unacceptably low level of response to study drug. Dose escalation was not allowed before Week 8. None None 79 191 150 191 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 18.1 View
Ulcerative keratitis NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 18.1 View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Abdominal pain lower NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Anal fistula NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Anorectal disorder NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Crohn's disease NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Dyspepsia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Enterovesical fistula NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Fistula of small intestine NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Gastritis erosive NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Ileus NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Intestinal obstruction NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Large intestine perforation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Pancreatitis acute NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Rectal haemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Small intestinal obstruction NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Small intestinal perforation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Cholangitis sclerosing NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 18.1 View
Cholecystitis NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 18.1 View
Cholecystitis chronic NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 18.1 View
Hepatic function abnormal NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 18.1 View
Abdominal abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Anal abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Bartholin's abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Cellulitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Cytomegalovirus infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Gastroenteritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Groin abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Infectious colitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Latent tuberculosis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Mesenteric abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Perirectal abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Peritonitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Peritonsillar abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Rectal abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Retroperitoneal abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Sepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Septic shock NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Tonsillitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Tooth abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Tuberculosis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Viral infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Viral upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Anastomotic fistula NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.1 View
Concussion NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.1 View
Fall NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.1 View
Gastrointestinal anastomotic leak NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.1 View
Intestinal anastomosis complication NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.1 View
Lower limb fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.1 View
Post procedural haemorrhage NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.1 View
Procedural complication NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.1 View
Weight decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Dehydration NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.1 View
Arthritis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.1 View
Oncocytoma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 18.1 View
Multiple sclerosis relapse NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Abortion missed NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA 18.1 View
Calculus ureteric NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 18.1 View
Nephrolithiasis NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 18.1 View
Renal colic NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 18.1 View
Asthma NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Chronic obstructive pulmonary disease NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Pneumothorax NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 18.1 View
Subcutaneous abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 18.1 View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Crohn's disease NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Bronchitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Gastroenteritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.1 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.1 View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Erythema NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.1 View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.1 View
Anxiety NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.1 View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.1 View