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 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 10:26 PM
NCT ID:
NCT02686658
Description:
The analysis population for all-cause mortality, serious adverse events (SAEs), and non-serious adverse events (NSAEs) consisted of all participants who received at least one dose of study treatment. Participants who received an injection of Zimura during this study were analyzed in the appropriate Zimura group according to the actual injections received.
Frequency Threshold:
5
Time Frame:
Adverse events were recorded starting at Day 1 after the first dose of study drug and continuing until 30 days after the last dose or until the last follow-up visit required by the protocol, whichever comes later (up to approximately 18 months from first dose).
Study:
NCT02686658
Study Brief:
Zimura in Participants With Geographic Atrophy Secondary to Dry 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 |
|---|---|---|---|---|---|---|---|---|
| Zimura 1 mg [Part 1] | Participants received 1 mg of Zimura in the study eye administered via intravitreal (IVT) injection on Day 1 and monthly up to 18 months. | 1 | None | 3 | 26 | 13 | 26 | View |
| Zimura 2 mg [Part 1] | Participants received 2 mg of Zimura in the study eye administered via IVT injection on Day 1 and monthly up to 18 months. | 0 | None | 4 | 25 | 13 | 25 | View |
| Sham [Part 1] | Participants received a Sham injection of an empty, needleless syringe administered in the study eye on Day 1 and monthly up to 18 months. | 0 | None | 7 | 26 | 10 | 26 | View |
| Zimura 2 mg (Zimura 2mg+Sham) [Part 2] | Participants received 2 mg of Zimura in the study eye administered via IVT injection and a Sham administration on Day 1 and monthly up to 18 months. | 1 | None | 8 | 42 | 34 | 42 | View |
| Zimura 4 mg (Zimura 2mg+Zimura 2mg) [Part 2] | Participants received 4 mg of Zimura in the study eye administered via 2 IVT injections on Day 1 and monthly up to 18 months. | 1 | None | 21 | 83 | 66 | 83 | View |
| Sham (Sham+Sham) [Part 2] | Participants received 2 Sham injections of empty, needleless syringes administered in the study eye on Day 1 and monthly up to 18 months. | 1 | None | 21 | 84 | 49 | 84 | View |
| Zimura (Any Dose) [Part 1 & Part 2 Combined] | Participants received a 1 mg, 2 mg, or 4 mg dose of Zimura in the study eye administered via 1 or 2 IVT injection(s) (or via IVT injection and a Sham administration) on Day 1 and monthly up to 18 months. | 3 | None | 36 | 176 | 126 | 176 | View |
| Sham [Part 1 & Part 2 Combined] | Participants received a Sham injection (or 2 Sham injections) of empty, needleless syringes administered in the study eye on Day 1 and monthly up to 18 months. | 1 | None | 28 | 110 | 59 | 110 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Iron deficiency anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 18.1 | View |
| Acute myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 18.1 | View |
| Mitral valve stenosis | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 18.1 | View |
| Ventricular extrasystoles | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 18.1 | View |
| Cardiac failure congestive | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 18.1 | View |
| Coronary artery disease | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 18.1 | View |
| Optic ischaemic neuropathy* | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 18.1 | View |
| Retinal detachment* | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 18.1 | View |
| Colitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.1 | View |
| Gastrointestinal necrosis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.1 | View |
| Lower gastrointestinal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.1 | View |
| Upper gastrointestinal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.1 | View |
| Abdominal hernia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.1 | View |
| Appendiceal mucocoele | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.1 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.1 | View |
| Faecaloma | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.1 | View |
| Gastrointestinal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.1 | View |
| Gastrooesophageal reflux disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.1 | View |
| Large intestinal stenosis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.1 | View |
| Small intestinal obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.1 | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 18.1 | View |
| Non-cardiac chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 18.1 | View |
| Bile duct stone | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 18.1 | View |
| Cholelithiasis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 18.1 | View |
| Cholecystitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 18.1 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.1 | View |
| Cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.1 | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.1 | View |
| Cystitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.1 | View |
| Diverticulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.1 | View |
| Escherichia urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.1 | View |
| Groin abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.1 | View |
| Urosepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.1 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.1 | View |
| Femur fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 18.1 | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 18.1 | View |
| Hip fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 18.1 | View |
| Rib fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 18.1 | View |
| Road traffic accident | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 18.1 | View |
| Ulna fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 18.1 | View |
| Head injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 18.1 | View |
| Upper limb fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 18.1 | View |
| Hyperglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 18.1 | View |
| Hyponatraemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 18.1 | View |
| Intervertebral disc protrusion | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | View |
| Lumbar spinal stenosis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | View |
| Osteoarthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | View |
| Bladder cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | View |
| Metastases to bone | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | View |
| Prostate cancer stage IV | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | View |
| Breast cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | View |
| Lung cancer metastatic | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | View |
| Lung neoplasm malignant | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | View |
| Metastases to adrenals | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | View |
| Metastases to central nervous system | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | View |
| Pancreatic carcinoma metastatic | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | View |
| Cerebrovascular accident | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18.1 | View |
| Cerebral infarction | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18.1 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18.1 | View |
| Ischaemic cerebral infarction | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18.1 | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18.1 | View |
| Cerebral haemorrhage | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18.1 | View |
| Ischaemic stroke | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18.1 | View |
| Lumbar radiculopathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18.1 | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 18.1 | View |
| Hallucination | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 18.1 | View |
| Chronic obstructive pulmonary disease | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | View |
| Pneumonia aspiration | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | View |
| Pneumothorax | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | View |
| Respiratory distress | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | View |
| Subclavian artery stenosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 18.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Rhinitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.1 | View |
| Intraocular pressure increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 18.1 | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 18.1 | View |
| Laceration | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 18.1 | View |
| Contusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 18.1 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 18.1 | View |
| Osteoarthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | View |
| Spinal column stenosis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | View |
| Dementia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18.1 | View |
| Hypokalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 18.1 | View |
| Conjunctival haemorrhage * | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 18.1 | View |
| Neovascular age-related macular degeneration* | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 18.1 | View |
| Conjunctival hyperaemia* | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 18.1 | View |
| Punctate keratitis* | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 18.1 | View |
| Eye pain* | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 18.1 | View |
| Vitreous detachment* | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 18.1 | View |
| Cataract* | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 18.1 | View |
| Visual acuity reduced* | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 18.1 | View |
| Conjunctival oedema* | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 18.1 | View |
| Choroidal neovascularization* | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 18.1 | View |
| Eye irritation* | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 18.1 | View |
| Posterior capsule opacification* | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 18.1 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.1 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.1 | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.1 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.1 | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.1 | View |