Adverse Events Module

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 @ 1:34 AM
Ignite Modification Date: 2025-12-25 @ 11:48 PM
NCT ID: NCT02510794
Description: Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
Frequency Threshold: 0.05
Time Frame: Baseline up to approximately Month 38
Study: NCT02510794
Study Brief: Study of the Efficacy and Safety of the Ranibizumab Port Delivery System for Sustained Delivery of Ranibizumab in Patients With Subfoveal Neovascular Age-Related Macular Degeneration
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Intravitreal Injection With Ranibizumab 0.5mg Participants received ranibizumab 0.5 mg monthly ITV injections of 10 mg/mL formulation at Day 1 and every month thereafter. 1 None 4 41 35 41 View
Port Delivery System With Ranibizumab 10mg/mL Participants had the Implant (prefilled with approximately 20 μL of 10-mg/mL ,approximately 0.2 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 10-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria. 1 None 14 58 57 58 View
Port Delivery System With Ranibizumab 40mg/mL Participants had the Implant (prefilled with approximately 20 μL of 40-mg/mL, approximately 0.8 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 40-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria. 2 None 19 62 59 62 View
Port Delivery System With Ranibizumab 100mg/mL Participants had the Implant (prefilled with approximately 20 μL of 100-mg/mL, approximately 2 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 100-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria. 1 None 17 59 58 59 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
APLASTIC ANAEMIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA version 21.1 View
ANGINA UNSTABLE SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA version 21.1 View
ATRIAL FIBRILLATION SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA version 21.1 View
ATRIAL FLUTTER SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA version 21.1 View
ATRIOVENTRICULAR BLOCK SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA version 21.1 View
CARDIAC FAILURE CONGESTIVE SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA version 21.1 View
CORONARY ARTERY DISEASE SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA version 21.1 View
MYOCARDIAL INFARCTION SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA version 21.1 View
CONJUNCTIVAL EROSION SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 21.1 View
HYPOTONY OF EYE SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 21.1 View
RETINAL HAEMORRHAGE SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 21.1 View
RETINAL TEAR SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 21.1 View
RETINOPATHY PROLIFERATIVE SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 21.1 View
RHEGMATOGENOUS RETINAL DETACHMENT SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 21.1 View
TRACTIONAL RETINAL DETACHMENT SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 21.1 View
VISION BLURRED SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 21.1 View
VISUAL ACUITY REDUCED SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 21.1 View
VITREOUS HAEMORRHAGE SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 21.1 View
GASTROINTESTINAL HAEMORRHAGE SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 21.1 View
GASTROOESOPHAGEAL REFLUX DISEASE SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 21.1 View
HIATUS HERNIA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 21.1 View
CHEST PAIN SYSTEMATIC_ASSESSMENT General disorders MedDRA version 21.1 View
CHOLECYSTITIS SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA version 21.1 View
CHOLECYSTITIS ACUTE SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA version 21.1 View
BACTERAEMIA SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 21.1 View
BRONCHITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 21.1 View
CELLULITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 21.1 View
DIVERTICULITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 21.1 View
ENDOPHTHALMITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 21.1 View
GASTROENTERITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 21.1 View
INFLUENZA SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 21.1 View
PNEUMONIA SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 21.1 View
POSTOPERATIVE WOUND INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 21.1 View
SEPSIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 21.1 View
URINARY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 21.1 View
BRAIN CONTUSION SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA version 21.1 View
CERVICAL VERTEBRAL FRACTURE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA version 21.1 View
CONJUNCTIVAL FILTERING BLEB LEAK SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA version 21.1 View
CONJUNCTIVAL RETRACTION SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA version 21.1 View
FALL SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA version 21.1 View
FRACTURE DISPLACEMENT SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA version 21.1 View
HIP FRACTURE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA version 21.1 View
HYPHAEMA SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA version 21.1 View
ILIOTIBIAL BAND SYNDROME SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA version 21.1 View
OCULAR PROCEDURAL COMPLICATION SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA version 21.1 View
PERIPROSTHETIC FRACTURE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA version 21.1 View
SKULL FRACTURED BASE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA version 21.1 View
SUBDURAL HAEMATOMA SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA version 21.1 View
UPPER LIMB FRACTURE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA version 21.1 View
WOUND SECRETION SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA version 21.1 View
INTRAOCULAR PRESSURE INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA version 21.1 View
WEIGHT DECREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA version 21.1 View
DEHYDRATION SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA version 21.1 View
DIABETES MELLITUS SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA version 21.1 View
INTERVERTEBRAL DISC DISORDER SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA version 21.1 View
ADENOCARCINOMA GASTRIC SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version 21.1 View
BREAST CANCER RECURRENT SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version 21.1 View
LUNG CARCINOMA CELL TYPE UNSPECIFIED STAGE IV SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version 21.1 View
PANCREATIC CARCINOMA SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version 21.1 View
CAROTID ARTERY STENOSIS SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 21.1 View
CEREBROVASCULAR ACCIDENT SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 21.1 View
DIZZINESS SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 21.1 View
HYPERTENSIVE ENCEPHALOPATHY SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 21.1 View
MIGRAINE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 21.1 View
PRESYNCOPE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 21.1 View
SUBARACHNOID HAEMORRHAGE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 21.1 View
TRANSIENT ISCHAEMIC ATTACK SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 21.1 View
DEVICE DISLOCATION SYSTEMATIC_ASSESSMENT Product Issues MedDRA version 21.1 View
DEVICE MALFUNCTION SYSTEMATIC_ASSESSMENT Product Issues MedDRA version 21.1 View
ACUTE KIDNEY INJURY SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA version 21.1 View
HAEMATURIA SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA version 21.1 View
PROSTATOMEGALY SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA version 21.1 View
ACUTE RESPIRATORY FAILURE SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 21.1 View
CHRONIC OBSTRUCTIVE PULMONARY DISEASE SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 21.1 View
LUNG CONSOLIDATION SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 21.1 View
PULMONARY EMBOLISM SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 21.1 View
RESPIRATORY DISORDER SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 21.1 View
AORTIC STENOSIS SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA version 21.1 View
FEMORAL ARTERY ANEURYSM SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA version 21.1 View
HYPERTENSION SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA version 21.1 View
HYPOTENSION SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA version 21.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
CHOROIDAL NEOVASCULARISATION SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 21.1 View
CONJUNCTIVAL BLEB SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 21.1 View
CONJUNCTIVAL HAEMORRHAGE SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 21.1 View
CONJUNCTIVAL HYPERAEMIA SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 21.1 View
CONJUNCTIVAL OEDEMA SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 21.1 View
CORNEAL OEDEMA SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 21.1 View
DERMATOCHALASIS SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 21.1 View
DIPLOPIA SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 21.1 View
DRY EYE SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 21.1 View
EYE IRRITATION SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 21.1 View
EYE PAIN SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 21.1 View
EYELIDS PRURITUS SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 21.1 View
FOREIGN BODY SENSATION IN EYES SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 21.1 View
IRIDOCYCLITIS SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 21.1 View
IRITIS SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 21.1 View
LACRIMATION INCREASED SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 21.1 View
MACULAR DEGENERATION SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 21.1 View
NEOVASCULAR AGE-RELATED MACULAR DEGENERATION SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 21.1 View
OCULAR HYPERAEMIA SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 21.1 View
PHOTOPHOBIA SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 21.1 View
POSTERIOR CAPSULE OPACIFICATION SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 21.1 View
PUNCTATE KERATITIS SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 21.1 View
RETINAL HAEMORRHAGE SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 21.1 View
VISION BLURRED SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 21.1 View
VISUAL ACUITY REDUCED SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 21.1 View
VITREOUS DETACHMENT SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 21.1 View
VITREOUS DISORDER SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 21.1 View
VITREOUS FLOATERS SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 21.1 View
VITREOUS HAEMORRHAGE SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 21.1 View
CONSTIPATION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 21.1 View
DIARRHOEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 21.1 View
GASTROOESOPHAGEAL REFLUX DISEASE SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 21.1 View
NAUSEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 21.1 View
CHEST PAIN SYSTEMATIC_ASSESSMENT General disorders MedDRA version 21.1 View
FATIGUE SYSTEMATIC_ASSESSMENT General disorders MedDRA version 21.1 View
BRONCHITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 21.1 View
DIVERTICULITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 21.1 View
EAR INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 21.1 View
HORDEOLUM SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 21.1 View
INFLUENZA SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 21.1 View
NASOPHARYNGITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 21.1 View
SINUSITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 21.1 View
TOOTH INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 21.1 View
UPPER RESPIRATORY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 21.1 View
URINARY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 21.1 View
CONTUSION SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA version 21.1 View
CORNEAL ABRASION SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA version 21.1 View
FALL SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA version 21.1 View
HYPHAEMA SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA version 21.1 View
PROCEDURAL PAIN SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA version 21.1 View
BLOOD CHOLESTEROL INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA version 21.1 View
INTRAOCULAR PRESSURE DECREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA version 21.1 View
INTRAOCULAR PRESSURE INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA version 21.1 View
ARTHRALGIA SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA version 21.1 View
ARTHRITIS SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA version 21.1 View
BACK PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA version 21.1 View
OSTEOARTHRITIS SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA version 21.1 View
PAIN IN EXTREMITY SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA version 21.1 View
ROTATOR CUFF SYNDROME SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA version 21.1 View
BASAL CELL CARCINOMA SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version 21.1 View
HEADACHE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 21.1 View
HYPERTONIC BLADDER SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA version 21.1 View
NEPHROLITHIASIS SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA version 21.1 View
COUGH SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 21.1 View
ACTINIC KERATOSIS SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA version 21.1 View
HYPERTENSION SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA version 21.1 View
ANTERIOR CHAMBER CELL SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 21.1 View
ANTERIOR CHAMBER FLARE SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 21.1 View
BLEPHARITIS SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 21.1 View
CATARACT CORTICAL SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 21.1 View
CATARACT NUCLEAR SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 21.1 View
EYE DISCHARGE SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 21.1 View
EYELID OEDEMA SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 21.1 View
EYELID PTOSIS SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 21.1 View
CATARACT SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 21.1 View
CHOROIDAL DETACHMENT SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 21.1 View