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 @ 12:34 AM
Ignite Modification Date: 2025-12-25 @ 10:43 PM
NCT ID: NCT01497067
Description: Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects enrolled in the study. Number at risk for ocular adverse events is presented with unit eyes.
Frequency Threshold: 5
Time Frame: Adverse events were collected from time of enrollment until study exit for an individual duration up to 6 years based on time of enrollment.
Study: NCT01497067
Study Brief: Long Term Safety Protocol for the AcrySof CACHET Phakic Lens
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
CACHET - Ocular All eyes previously implanted with ACRYSOF CACHET Phakic Lens (L-series) 0 None 276 1123 0 1123 View
CACHET - Systemic All subjects previously implanted with ACRYSOF CACHET Phakic Lens (L-series) 3 None 24 657 0 657 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Visual acuity tests abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Obesity SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Lumbar spinal stenosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Spinal deformity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Intracranial aneurysm SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Myelopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Radiculopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Eye operation SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA View
Glaucoma surgery SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA View
Hip arthroplasty SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA View
Hysterectomy SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA View
Lens extraction SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA View
Retinal laser coagulation SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA View
Coronary artery occlusion SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
Angle closure glaucoma SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Cataract SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Cataract cortical SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Cataract nuclear SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Cataract subcapsular SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Choroidal neovascularisation SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Corneal endothelial cell loss SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Corneal oedema SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Exophthalmos SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Glaucoma SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Iris adhesions SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Iris atrophy SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Iris disorder SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Lens discolouration SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Lens dislocation SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Lenticular opacities SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Macular oedema SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Ocular hypertension SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Open angle glaucoma SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Pupillary deformity SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Retinal degeneration SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Retinal detachment SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Retinal tear SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Visual acuity reduced SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Accidental death SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Device dislocation SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Eye complication associated with device SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Appendicitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Dislocation of vertebra SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Lumbar vertebral fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Intraocular pressure increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Spinal osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Breast cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Meningioma benign SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Pituitary tumour SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Prostate cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Throat cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Uterine leiomyoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Visual field defect SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Vaginal haemorrhage SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Cataract operation SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA View
Corneal operation SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA View
Intra-ocular injection SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA View
Intraocular lens extraction SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA View
Intraocular lens implant SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA View
Intraocular lens repositioning SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA View
Iridotomy SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA View
Iris operation SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA View
Keratomileusis SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA View
Knee operation SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA View
Retinal operation SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA View
Retinopexy SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA View
Scleral buckling surgery SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA View
Trabeculectomy SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA View
Trabeculoplasty SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA View
Vitrectomy SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Pulmonary fibrosis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Other Events(If Any):