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 @ 5:31 PM
Ignite Modification Date:
2025-12-24 @ 5:31 PM
NCT ID:
NCT04437368
Description:
Full Analysis Set - all randomized participants. Part 1 enrolled subjects with Complement factor I (CFI) rare variant; Part 2 enrolled subjects regardless of genotype (i.e., CFI-rare and CFI-non-rare variants) . Part 1 and Part 2 are not defined in the protocol as distinct arms. Since there were no safety concerns, it was determined that there was no scientific value in reporting safety results by part / genotype, but by treatment.
Frequency Threshold:
0
Time Frame:
Adverse events are reported from randomization up to end of study, for a maximum timeframe of approximately 96 weeks.
Study:
NCT04437368
Study Brief:
EXPLORE: A Phase II Study to Evaluate the Safety and Efficacy of Two Doses of GT005
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| GT005 Low Dose [2E10 vg] | GT005 Low Dose \[2E10 vg\] | 3 | None | 5 | 52 | 19 | 52 | View |
| GT005 High Dose [2E11 vg] | GT005 High dose \[2E11 vg\] | 0 | None | 2 | 9 | 9 | 9 | View |
| Untreated Control | Subjects allocated to the untreated control group did not receive any treatment. | 2 | None | 4 | 37 | 16 | 37 | View |
| Overall | Overall | 5 | None | 11 | 98 | 44 | 98 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Visual acuity reduced - Study eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.1) | View |
| Cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (26.1) | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (26.1) | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (26.1) | View |
| Staphylococcal infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (26.1) | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (26.1) | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (26.1) | View |
| Hip fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (26.1) | View |
| Rib fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (26.1) | View |
| Breast cancer metastatic | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (26.1) | View |
| Hepatic cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (26.1) | View |
| Lung adenocarcinoma stage IV | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (26.1) | View |
| Lung neoplasm malignant | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (26.1) | View |
| Amyotrophic lateral sclerosis | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (26.1) | View |
| Cerebrovascular accident | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (26.1) | View |
| Encephalopathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (26.1) | View |
| Sciatica | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (26.1) | View |
| Seizure | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (26.1) | View |
| Choking | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | View |
| Hypoxia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | View |
| Pleural effusion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | View |
| Pneumothorax | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Conjunctivitis allergic - Study eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.1) | View |
| Dry eye - Fellow eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.1) | View |
| Dry eye - Study eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.1) | View |
| Eye pain - Study eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.1) | View |
| Eye pruritus - Fellow eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.1) | View |
| Eye pruritus - Study eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.1) | View |
| Hypotony maculopathy - Study eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.1) | View |
| Iridocyclitis - Study eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.1) | View |
| Iritis - Study eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.1) | View |
| Keratitis - Study eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.1) | View |
| Lacrimation increased - Study eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.1) | View |
| Macular hole - Study eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.1) | View |
| Meibomian gland dysfunction - Fellow eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.1) | View |
| Meibomian gland dysfunction - Study eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.1) | View |
| Metamorphopsia - Study eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.1) | View |
| Ocular hypertension - Study eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.1) | View |
| Open angle glaucoma - Fellow eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.1) | View |
| Open angle glaucoma - Study eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.1) | View |
| Photophobia - Study eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.1) | View |
| Photopsia - Fellow eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.1) | View |
| Photopsia - Study eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.1) | View |
| Posterior capsule opacification - Fellow eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.1) | View |
| Posterior capsule opacification - Study eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.1) | View |
| Punctate keratitis - Study eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.1) | View |
| Retinal degeneration - Fellow eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.1) | View |
| Retinal depigmentation - Study eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.1) | View |
| Retinal haemorrhage - Fellow eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.1) | View |
| Retinal haemorrhage - Study eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.1) | View |
| Retinal oedema - Fellow eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.1) | View |
| Retinal pigmentation - Study eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.1) | View |
| Retinal tear - Fellow eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.1) | View |
| Visual impairment - Fellow eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.1) | View |
| Visual impairment - Study eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.1) | View |
| Visual snow syndrome - Study eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.1) | View |
| Vitreous detachment - Fellow eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.1) | View |
| Vitreous floaters - Fellow eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.1) | View |
| Vitreous floaters - Study eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.1) | View |
| Vitreous haemorrhage - Study eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.1) | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (26.1) | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (26.1) | View |
| Diverticulum intestinal | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (26.1) | View |
| Dysphagia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (26.1) | View |
| Hiatus hernia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (26.1) | View |
| Inguinal hernia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (26.1) | View |
| Loose tooth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (26.1) | View |
| Oesophageal achalasia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (26.1) | View |
| Umbilical hernia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (26.1) | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (26.1) | View |
| Drug intolerance | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (26.1) | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (26.1) | View |
| COVID-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (26.1) | View |
| Cystitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (26.1) | View |
| Ear infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (26.1) | View |
| Herpes zoster | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (26.1) | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (26.1) | View |
| Contusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (26.1) | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (26.1) | View |
| Hand fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (26.1) | View |
| Joint dislocation | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (26.1) | View |
| Ligament sprain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (26.1) | View |
| Lower limb fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (26.1) | View |
| Lumbar vertebral fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (26.1) | View |
| Meniscus injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (26.1) | View |
| Muscle strain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (26.1) | View |
| Post procedural discomfort - Study eye | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (26.1) | View |
| Procedural pain - Study eye | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (26.1) | View |
| Skin abrasion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (26.1) | View |
| Skin laceration | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (26.1) | View |
| Suture related complication - Study eye | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (26.1) | View |
| Tendon rupture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (26.1) | View |
| Upper limb fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (26.1) | View |
| Blood potassium decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (26.1) | View |
| Blood pressure decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (26.1) | View |
| Blood pressure increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (26.1) | View |
| C-reactive protein increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (26.1) | View |
| Intraocular pressure increased - Study eye | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (26.1) | View |
| Dyslipidaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (26.1) | View |
| Obesity | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (26.1) | View |
| Vitamin D deficiency | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (26.1) | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (26.1) | View |
| Muscle contracture | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (26.1) | View |
| Osteoarthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (26.1) | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (26.1) | View |
| Plantar fasciitis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (26.1) | View |
| Rotator cuff syndrome | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (26.1) | View |
| Spinal osteoarthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (26.1) | View |
| Temporomandibular joint syndrome | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (26.1) | View |
| Breast cancer recurrent | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (26.1) | View |
| Meningioma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (26.1) | View |
| Carpal tunnel syndrome | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (26.1) | View |
| Cognitive disorder | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (26.1) | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (26.1) | View |
| Facial paralysis | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (26.1) | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (26.1) | View |
| Hemiparesis | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (26.1) | View |
| Seizure | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (26.1) | View |
| Tension headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (26.1) | View |
| Transient ischaemic attack | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (26.1) | View |
| Sleep disorder | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (26.1) | View |
| Dysuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (26.1) | View |
| Renal impairment | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (26.1) | View |
| Urethral haemorrhage | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (26.1) | View |
| Urethral polyp | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (26.1) | View |
| Vaginal haemorrhage | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (26.1) | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | View |
| Rosacea | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (26.1) | View |
| Telangiectasia - Fellow eye | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (26.1) | View |
| Telangiectasia - Study eye | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (26.1) | View |
| Urticaria | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (26.1) | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (26.1) | View |
| Orthostatic hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (26.1) | View |
| Peripheral ischaemia | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (26.1) | View |
| Blepharitis - Study eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.1) | View |
| Cataract - Fellow eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.1) | View |
| Cataract - Study eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.1) | View |
| Cataract nuclear - Study eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.1) | View |
| Choroidal detachment - Study eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.1) | View |
| Choroidal neovascularisation - Fellow eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.1) | View |
| Conjunctival haemorrhage - Study eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.1) | View |
| Conjunctival hyperaemia - Study eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.1) | View |
| Conjunctivitis allergic - Fellow eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.1) | View |
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (26.1) | View |
| Hypochromic anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (26.1) | View |
| Cardiomyopathy | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (26.1) | View |
| Coronary artery disease | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (26.1) | View |
| Vertigo | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (26.1) | View |
| Anterior chamber cell - Study eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.1) | View |
| Anterior chamber flare - Study eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.1) | View |
| Blepharitis - Fellow eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.1) | View |