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 @ 4:27 PM
Ignite Modification Date:
2025-12-24 @ 4:27 PM
NCT ID:
NCT04435366
Description:
Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group.
ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.
Frequency Threshold:
5
Time Frame:
All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months
Study:
NCT04435366
Study Brief:
A Phase 3 Safety and Efficacy Study of Intravitreal Administration of Zimura (Complement C5 Inhibitor)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Avacincaptad Pegol Only (up to 12 Months) | Participants received ACP 2 mg/eye via IVT injections monthly through Month 11 (Year 1). | 4 | None | 31 | 225 | 100 | 225 | View |
| Avacincaptad Pegol Only (12 to 24 Months) | Participants were re-randomized at month 12 to receive ACP 2 mg/eye via IVT injections monthly from month 12 through month 23 (Year 2). Participants were followed up until month 24. | 1 | None | 18 | 96 | 51 | 96 | View |
| Avacincaptad Pegol and Sham Only (12 to 24 Months) | Participants were re-randomized at month 12, to receive ACP 2 mg/eye via IVT injections every other month at months 13, 15, 17, 19, 21, and 23 and sham injections at months 12, 14, 16,18, 20, and 22 (Year 2). Participants were followed up until month 24. | 4 | None | 16 | 93 | 41 | 93 | View |
| Sham Only (up to 12 Months) | Participants received sham injections through Month 11 (Year 1). | 1 | None | 36 | 222 | 83 | 222 | View |
| Sham Only (12 to 24 Months) | Participants continued to receive monthly sham injection from month 12 through month 23 (Year 2). Participants were followed up until month 24. | 7 | None | 25 | 203 | 77 | 203 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Coronary artery disease | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v24.1 | View |
| Coronary artery insufficiency | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v24.1 | View |
| Microcytic anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v24.1 | View |
| Normocytic anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v24.1 | View |
| Acute myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v24.1 | View |
| Angina pectoris | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v24.1 | View |
| Atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v24.1 | View |
| Atrial flutter | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v24.1 | View |
| Atrial tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v24.1 | View |
| Atrioventricular block second degree | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v24.1 | View |
| Cardiac failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v24.1 | View |
| Cardiac failure chronic | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v24.1 | View |
| Cardiac failure congestive | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v24.1 | View |
| Cardio-respiratory arrest | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v24.1 | View |
| Intracardiac thrombus | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v24.1 | View |
| Mitral valve incompetence | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v24.1 | View |
| Myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v24.1 | View |
| Myocardial ischaemia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v24.1 | View |
| Sinus arrest | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v24.1 | View |
| Ventricular extrasystoles | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v24.1 | View |
| Mobile caecum syndrome | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA v24.1 | View |
| Vertigo | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA v24.1 | View |
| Choroidal neovascularisation | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v24.1 | View |
| Retinal haemorrhage | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v24.1 | View |
| Visual acuity reduced | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v24.1 | View |
| Visual acuity reduced transiently | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v24.1 | View |
| Barrett's oesophagus | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v24.1 | View |
| Enterovesical fistula | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v24.1 | View |
| Gastric haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v24.1 | View |
| Haemorrhoidal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v24.1 | View |
| Inguinal hernia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v24.1 | View |
| Large intestine polyp | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v24.1 | View |
| Oesophageal spasm | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v24.1 | View |
| Pancreatitis chronic | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v24.1 | View |
| Rectal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v24.1 | View |
| Small intestinal obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v24.1 | View |
| Upper gastrointestinal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v24.1 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v24.1 | View |
| Chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v24.1 | View |
| Biliary obstruction | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA v24.1 | View |
| Cholecystitis acute | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA v24.1 | View |
| Hepatic cirrhosis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA v24.1 | View |
| COVID-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v24.1 | View |
| COVID-19 pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v24.1 | View |
| Clostridium difficile colitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v24.1 | View |
| Clostridium difficile infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v24.1 | View |
| Cystitis bacterial | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v24.1 | View |
| Diverticulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v24.1 | View |
| Diverticulitis intestinal perforated | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v24.1 | View |
| Endophthalmitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v24.1 | View |
| Herpes zoster | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v24.1 | View |
| Listeria sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v24.1 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v24.1 | View |
| Pneumonia bacterial | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v24.1 | View |
| Postoperative abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v24.1 | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v24.1 | View |
| Urosepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v24.1 | View |
| Wound infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v24.1 | View |
| Ankle fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v24.1 | View |
| Exposure to toxic agent | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v24.1 | View |
| Facial bones fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v24.1 | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v24.1 | View |
| Femur fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v24.1 | View |
| Humerus fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v24.1 | View |
| Joint injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v24.1 | View |
| Lumbar vertebral fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v24.1 | View |
| Multiple fractures | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v24.1 | View |
| Procedural intestinal perforation | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v24.1 | View |
| Procedural pain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v24.1 | View |
| Radius fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v24.1 | View |
| Rib fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v24.1 | View |
| Spinal compression fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v24.1 | View |
| Spinal fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v24.1 | View |
| Subdural haematoma | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v24.1 | View |
| Tibia fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v24.1 | View |
| Traumatic intracranial haemorrhage | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v24.1 | View |
| Upper limb fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v24.1 | View |
| Wrist fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v24.1 | View |
| Type 2 diabetes mellitus | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v24.1 | View |
| Intervertebral disc protrusion | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v24.1 | View |
| Lumbar spinal stenosis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v24.1 | View |
| Osteoarthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v24.1 | View |
| Tenosynovitis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v24.1 | View |
| Acute leukaemia | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v24.1 | View |
| Basal cell carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v24.1 | View |
| Breast cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v24.1 | View |
| Colon cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v24.1 | View |
| Meningioma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v24.1 | View |
| Non-small cell lung cancer stage IIIA | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v24.1 | View |
| Sinonasal papilloma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v24.1 | View |
| Squamous cell carcinoma of lung | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v24.1 | View |
| Cerebral haemorrhage | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v24.1 | View |
| Cerebral infarction | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v24.1 | View |
| Cerebrovascular accident | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v24.1 | View |
| Intracranial aneurysm | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v24.1 | View |
| Metabolic encephalopathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v24.1 | View |
| Neuromyelitis optica spectrum disorder | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v24.1 | View |
| Transient ischaemic attack | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v24.1 | View |
| Device dislocation | SYSTEMATIC_ASSESSMENT | Product Issues | MedDRA v24.1 | View |
| Device lead damage | SYSTEMATIC_ASSESSMENT | Product Issues | MedDRA v24.1 | View |
| Prostatitis | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA v24.1 | View |
| Acute respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v24.1 | View |
| Chronic obstructive pulmonary disease | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v24.1 | View |
| Dyspnoea exertional | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v24.1 | View |
| Emphysema | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v24.1 | View |
| Pleural effusion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v24.1 | View |
| Pneumothorax | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v24.1 | View |
| Pulmonary embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v24.1 | View |
| Respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v24.1 | View |
| Aortic aneurysm | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v24.1 | View |
| Aortic stenosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v24.1 | View |
| Circulatory collapse | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v24.1 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v24.1 | View |
| Hypertensive emergency | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v24.1 | View |
| Neurogenic shock | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v24.1 | View |
| Peripheral arterial occlusive disease | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v24.1 | View |
| Peripheral artery occlusion | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v24.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Cataract | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v24.1 | View |
| Choroidal neovascularisation | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v24.1 | View |
| Conjunctival haemorrhage | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v24.1 | View |
| Conjunctival hyperaemia | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v24.1 | View |
| Punctate keratitis | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v24.1 | View |
| Retinal haemorrhage | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v24.1 | View |
| COVID-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v24.1 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v24.1 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v24.1 | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v24.1 | View |
| Intraocular pressure increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v24.1 | View |