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 @ 1:38 AM
Ignite Modification Date:
2025-12-25 @ 11:53 PM
NCT ID:
NCT02504294
Description:
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Frequency Threshold:
5
Time Frame:
None
Study:
NCT02504294
Study Brief:
A Phase 3b Study of Erythropoietin Drugs Using a Specified Dosing Algorithm in Patients With Chronic Kidney Disease on Hemodialysis
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Epoetin Hospira | Participants received intravenous (IV) injection of Epoetin Hospira as per the analogous version of Fresenius Medical Care North America (FMCNA) Erythropoietin Stimulating Agent (ESA) dosing algorithm Corporate Medical Advisory board (cMAB algorithm 1) along with IV iron as per the FMCNA standard of care. Drug was administered up to maximum 3 times per week up to Week 24. Participants were followed up to Week 26. | None | None | 66 | 212 | 10 | 212 | View |
| Epogen | Participants received their ongoing standard of care which included IV injection of Epogen, as per the current version of the FMCNA ESA dosing algorithm cMAB 5 along with IV iron as per the FMCNA standard of care. Drug was administered up to maximum 3 times per week up to Week 24. Participants were followed up to Week 26. | None | None | 64 | 206 | 21 | 206 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 19.0 | View |
| Haemorrhagic anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 19.0 | View |
| Acute myocardial infarction | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 19.0 | View |
| Angina pectoris | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 19.0 | View |
| Angina unstable | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 19.0 | View |
| Atrial fibrillation | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 19.0 | View |
| Atrial flutter | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 19.0 | View |
| Bradycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 19.0 | View |
| Cardiac arrest | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 19.0 | View |
| Cardiac failure congestive | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 19.0 | View |
| Cardio-respiratory arrest | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 19.0 | View |
| Coronary artery disease | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 19.0 | View |
| Diastolic dysfunction | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 19.0 | View |
| Hypertensive heart disease | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 19.0 | View |
| Myocardial infarction | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 19.0 | View |
| Ventricular tachycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 19.0 | View |
| Hyperparathyroidism secondary | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA 19.0 | View |
| Parathyroid disorder | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA 19.0 | View |
| Abdominal distension | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.0 | View |
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.0 | View |
| Abdominal pain lower | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.0 | View |
| Gastrointestinal haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.0 | View |
| Impaired gastric emptying | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.0 | View |
| Large intestine perforation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.0 | View |
| Lower gastrointestinal haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.0 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.0 | View |
| Upper gastrointestinal haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.0 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.0 | View |
| Asthenia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 19.0 | View |
| Catheter site haemorrhage | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 19.0 | View |
| Chest discomfort | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 19.0 | View |
| Chest pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 19.0 | View |
| Condition aggravated | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 19.0 | View |
| Death | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 19.0 | View |
| Early satiety | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 19.0 | View |
| Generalised oedema | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 19.0 | View |
| Hernia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 19.0 | View |
| Impaired healing | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 19.0 | View |
| Medical device site ulcer | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 19.0 | View |
| Pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 19.0 | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 19.0 | View |
| Systemic inflammatory response syndrome | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 19.0 | View |
| Ulcer haemorrhage | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 19.0 | View |
| Cholecystitis acute | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 19.0 | View |
| Cholelithiasis | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 19.0 | View |
| Bacteraemia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.0 | View |
| Cellulitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.0 | View |
| Cellulitis of male external genital organ | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.0 | View |
| Clostridium difficile colitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.0 | View |
| Device related sepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.0 | View |
| Diverticulitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.0 | View |
| Endocarditis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.0 | View |
| Escherichia bacteraemia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.0 | View |
| Gastroenteritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.0 | View |
| Graft infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.0 | View |
| Incision site infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.0 | View |
| Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.0 | View |
| Osteomyelitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.0 | View |
| Osteomyelitis chronic | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.0 | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.0 | View |
| Pneumonia bacterial | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.0 | View |
| Pyelonephritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.0 | View |
| Pyuria | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.0 | View |
| Respiratory syncytial virus infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.0 | View |
| Sepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.0 | View |
| Septic shock | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.0 | View |
| Subcutaneous abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.0 | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.0 | View |
| Wound infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.0 | View |
| Arteriovenous fistula site haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 19.0 | View |
| Arteriovenous fistula thrombosis | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 19.0 | View |
| Arteriovenous graft site haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 19.0 | View |
| Arteriovenous graft thrombosis | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 19.0 | View |
| Fall | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 19.0 | View |
| Femur fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 19.0 | View |
| Intentional product misuse | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 19.0 | View |
| Limb injury | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 19.0 | View |
| Post procedural pulmonary embolism | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 19.0 | View |
| Pubis fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 19.0 | View |
| Rib fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 19.0 | View |
| Tibia fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 19.0 | View |
| Vascular access complication | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 19.0 | View |
| Vascular access malfunction | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 19.0 | View |
| Vascular bypass dysfunction | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 19.0 | View |
| Vascular pseudoaneurysm | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 19.0 | View |
| Wound | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 19.0 | View |
| Wound dehiscence | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 19.0 | View |
| Haemoglobin decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 19.0 | View |
| Diabetic ketoacidosis | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 19.0 | View |
| Failure to thrive | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 19.0 | View |
| Fluid overload | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 19.0 | View |
| Hyperglycaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 19.0 | View |
| Hyperkalaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 19.0 | View |
| Hypoglycaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 19.0 | View |
| Hypovolaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 19.0 | View |
| Malnutrition | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 19.0 | View |
| Muscular weakness | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | View |
| Pain in extremity | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | View |
| Systemic lupus erythematosus | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | View |
| Lung carcinoma cell type unspecified stage IV | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | View |
| Prostate cancer | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | View |
| Cerebrovascular accident | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 19.0 | View |
| Encephalopathy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 19.0 | View |
| Hemiparesis | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 19.0 | View |
| Ischaemic stroke | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 19.0 | View |
| Lethargy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 19.0 | View |
| Metabolic encephalopathy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 19.0 | View |
| Syncope | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 19.0 | View |
| Transient ischaemic attack | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 19.0 | View |
| Abortion spontaneous | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA 19.0 | View |
| Anxiety | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 19.0 | View |
| Major depression | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 19.0 | View |
| Obstructive uropathy | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 19.0 | View |
| Urethral haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 19.0 | View |
| Acute pulmonary oedema | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | View |
| Acute respiratory failure | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | View |
| Asthma | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | View |
| Bronchial secretion retention | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | View |
| Choking | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | View |
| Chronic obstructive pulmonary disease | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | View |
| Dyspnoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | View |
| Hypoxia | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | View |
| Pleural effusion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | View |
| Pulmonary oedema | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | View |
| Respiratory arrest | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | View |
| Respiratory failure | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | View |
| Tracheomalacia | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | View |
| Purpura | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 19.0 | View |
| Renal transplant | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 19.0 | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 19.0 | View |
| Hypertensive crisis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 19.0 | View |
| Hypotension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 19.0 | View |
| Peripheral artery occlusion | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 19.0 | View |
| Steal syndrome | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 19.0 | View |