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 @ 6:45 PM
Ignite Modification Date: 2025-12-25 @ 4:16 PM
NCT ID: NCT01085357
Description: Reports of AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the Investigator as outlined in the study protocol.
Frequency Threshold: 5
Time Frame: An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury or any untoward clinical sign occurring in a study subject, whether or not related to the CyPass device. AEs were collected from time of consent to study exit (Month 24 postoperative).
Study: NCT01085357
Study Brief: Study of an Implantable Device for Lowering Intraocular Pressure in Glaucoma Patients Undergoing Cataract Surgery
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
CyPass Micro-Stent + Cataract Surgery Subjects received the CyPass Micro-Stent at the conclusion of their cataract surgery None None 53 374 101 374 View
Cataract Surgery Only Subjects did not receive the CyPass Micro-Stent at the conclusion of their cataract surgery None None 13 131 39 131 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cardiac failure congestive SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiac failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardio-respiratory arrest SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Ventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hiatal hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Small intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Death SYSTEMATIC_ASSESSMENT General disorders None View
Multiple organ dysfunction syndrome SYSTEMATIC_ASSESSMENT General disorders None View
Biilary colic SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Cholecystitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Hepatic cirrhosis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Infectious colitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hip fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Patella fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Skull fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Spinal cord injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Subdural haematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Arteriogram coronary SYSTEMATIC_ASSESSMENT Investigations None View
Electrolyte imbalance SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Bladder cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Bladder neoplasm SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Brain neoplasm SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Brain neoplasm malignant SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Breast cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Colon cancer metastatic SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Myelodysplastic syndrome SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Pancreatic carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Prostate cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Small cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Cerebral haemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Cerebral infarction SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Cerebrospinal fluid leakage SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Cerebrovascular accident SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Temporal lobe epilepsy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Transient ischaemic attack SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Mental status changes SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Suicide attempt SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Nephrolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urinary retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Uterine haemorrhage SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Aneurysm repair SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Cardiac pacemaker insertion SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Coronary arterial stent insertion SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Hip arthroplasty SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Knee arthroplasty SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Limb operation SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Aortic dissection SYSTEMATIC_ASSESSMENT Vascular disorders None View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders None View
Knee operation SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
BCVA loss => 10 letters read at/after 3 month postoperative visit SYSTEMATIC_ASSESSMENT Eye disorders None View
Secondary ocular surgical intervention SYSTEMATIC_ASSESSMENT Eye disorders None View
Worsening in visual field MD by => 2.5 dB as compared with preoperative SYSTEMATIC_ASSESSMENT Nervous system disorders None View
AC cell and flare requiring steroid treatment at/after 30 days postoperative SYSTEMATIC_ASSESSMENT Eye disorders None View
Worsening in any ocular symptom by ≥ 2 points to severe/very severe at/after 3 months postoperative SYSTEMATIC_ASSESSMENT Eye disorders None View