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 @ 3:43 PM
Ignite Modification Date: 2025-12-25 @ 1:51 PM
NCT ID: NCT01298492
Description: None
Frequency Threshold: 5
Time Frame: From Start of Study Treatment up to Safety Follow up (Week 96)
Study: NCT01298492
Study Brief: A Study To Monitor Long-Term Treatment With PF-00547659
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-00547659 75 mg Participants received PF-00547659 75 mg subcutaneous injection once in every 4 weeks through Week 72. One time dose escalation to 225 mg subcutaneous injection was allowed after 8 weeks of the study for the participants who experienced clinical deterioration or unacceptably low level of response to study drug. One time dose de-escalation to 22.5 mg subcutaneous injection due to intolerance or AEs was also allowed after the investigator carefully assessed the status of the participant. 2 None 118 268 206 268 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 19.0 View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.0 View
Arthritis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.0 View
Arthritis enteropathic NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.0 View
Muscle spasms NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.0 View
Muscular weakness NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.0 View
Spinal column stenosis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.0 View
Spinal osteoarthritis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.0 View
Colon cancer NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.0 View
Metastatic neoplasm NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.0 View
Renal cancer NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.0 View
Adrenocortical insufficiency acute NON_SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 19.0 View
Visual impairment NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 19.0 View
Abdominal hernia obstructive NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Anal fistula NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Anal stenosis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Colitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Colitis ulcerative NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Crohn's disease NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Duodenitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Enterocutaneous fistula NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Gastrointestinal disorder NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Ileal stenosis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Ileus NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Intestinal fistula NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Intestinal haemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Intestinal obstruction NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Large intestinal obstruction NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Large intestinal stenosis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Melaena NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Pancreatitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Pancreatitis acute NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Small intestinal obstruction NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
General physical health deterioration NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Coronary artery disease NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 19.0 View
Myocardial infarction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 19.0 View
Abdominal abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Abdominal wall abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Abscess intestinal NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Abscess neck NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Anal abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Clostridium difficile infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Device related infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Gastroenteritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Gastroenteritis viral NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Liver abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Pelvic abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Perirectal abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Peritonitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Postoperative abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Rotavirus infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Splenic abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Tonsillitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Vulval abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Anastomotic leak NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.0 View
Fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.0 View
Gastrointestinal stoma complication NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.0 View
Humerus fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.0 View
Postoperative ileus NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.0 View
Stomal hernia NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.0 View
Upper limb fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.0 View
Wound dehiscence NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.0 View
Blood creatine phosphokinase mm increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Haematocrit decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Bladder dysfunction NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 19.0 View
Nephrolithiasis NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 19.0 View
Ureterolithiasis NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 19.0 View
Urinoma NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 19.0 View
Cholecystitis NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 19.0 View
Cholecystitis acute NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 19.0 View
Cholelithiasis NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 19.0 View
Hepatic cyst NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 19.0 View
Fluid retention NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 19.0 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Intracranial venous sinus thrombosis NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Benign breast lump removal NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 19.0 View
Female genital tract fistula NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 19.0 View
Menorrhagia NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 19.0 View
Perineal fistula NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 19.0 View
Pleural effusion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Pneumonia aspiration NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Pyoderma gangrenosum NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Pharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Anal abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Bronchitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Gastroenteritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Influenza NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Asthenia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.0 View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.0 View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Anal fissure NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Aphthous ulcer NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Crohn's disease NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View