Adverse Events Module

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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 @ 3:39 AM
Ignite Modification Date: 2025-12-26 @ 2:24 AM
NCT ID: NCT01320202
Description: The number of subjects included in the safety population = 300, which is 5 patients fewer than the number of patients randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Five subjects withdrew from Stage 2 and 2 subjects withdrew from Stage 3 prior to exposure.
Frequency Threshold: 3.0
Time Frame: In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
Study: NCT01320202
Study Brief: Continuous Soluble Ferric Pyrophosphate (SFP) Iron Delivery Via Dialysate in Hemodialysis Patients
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Stage 2 Placebo (Standard Dialysate) 0 micrograms (µg) of iron / deciliter (dL) of dialysate. Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week in Stage 2 for up to 48 weeks. None None 45 151 100 151 View
Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate 11 micrograms (µg) of iron / deciliter (dL) of dialysate. Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week in Stage 2 for up to 48 weeks. None None 36 149 96 149 View
Stage 3 Soluble Ferric Pyrophosphate (SFP) in Dialysate 11 micrograms (µg) of iron / deciliter (dL) of dialysate. Soluble Ferric Pyrophosphate (SFP): Upon completion of Stage 2, patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week in Stage 3 for up to 72 weeks of total study participation (Stage 2 + Stage 3). None None 81 205 148 205 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
ADVERSE DRUG REACTION SYSTEMATIC_ASSESSMENT General disorders None View
ANAEMIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
ARTERIOVENOUS FISTULA SITE HAEMATOMA SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
CONVULSION SYSTEMATIC_ASSESSMENT Nervous system disorders None View
CORONARY ARTERY DISEASE SYSTEMATIC_ASSESSMENT Cardiac disorders None View
GASTROENTERITIS VIRAL SYSTEMATIC_ASSESSMENT Infections and infestations None View
GASTROINTESTINAL HAEMORRHAGE SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
GASTROOESOPHAGEAL REFLUX DISEASE SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
OESOPHAGEAL ULCER HAEMORRHAGE SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
ORTHOSTATIC HYPOTENSION SYSTEMATIC_ASSESSMENT Vascular disorders None View
OSTEOARTHRITIS SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
OSTEOMYELITIS SYSTEMATIC_ASSESSMENT Infections and infestations None View
OVARIAN LOW MALIGNANT POTENTIAL TUMOUR SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
PANCREATITIS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
PANCREATITIS ACUTE SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
PERIPHERAL ARTERIAL OCCLUSIVE DISEASE SYSTEMATIC_ASSESSMENT Vascular disorders None View
PERIPHERAL VASCULAR DISORDER SYSTEMATIC_ASSESSMENT Vascular disorders None View
PLEURAL EFFUSION SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
PNEUMONIA SYSTEMATIC_ASSESSMENT Infections and infestations None View
PNEUMONIA ASPIRATION SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
POLYMYALGIA RHEUMATICA SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
PORTAL HYPERTENSIVE GASTROPATHY SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
POST PROCEDURAL HAEMATOMA SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
PROCEDURAL HYPERTENSION SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
PROCEDURAL HYPOTENSION SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
PROSTATE CANCER SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
PULMONARY CONGESTION SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
PULMONARY OEDEMA SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
PYREXIA SYSTEMATIC_ASSESSMENT General disorders None View
RENAL CELL CARCINOMA SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
RENAL CYST HAEMORRHAGE SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
RENAL CYST INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations None View
RESPIRATORY ARREST SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
RESPIRATORY DISTRESS SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
RESPIRATORY FAILURE SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
ROAD TRAFFIC ACCIDENT SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
SEPSIS SYSTEMATIC_ASSESSMENT Infections and infestations None View
SHOCK SYSTEMATIC_ASSESSMENT Vascular disorders None View
SKIN ULCER SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
SMALL INTESTINAL OBSTRUCTION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
SPONDYLOLISTHESIS SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
STAPHYLOCOCCAL BACTERAEMIA SYSTEMATIC_ASSESSMENT Infections and infestations None View
STENT-GRAFT ENDOLEAK SYSTEMATIC_ASSESSMENT General disorders None View
SUDDEN DEATH SYSTEMATIC_ASSESSMENT General disorders None View
SUPRAVENTRICULAR TACHYCARDIA SYSTEMATIC_ASSESSMENT Cardiac disorders None View
SYNCOPE SYSTEMATIC_ASSESSMENT Nervous system disorders None View
THROMBOCYTOPENIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
TOXICITY TO VARIOUS AGENTS SYSTEMATIC_ASSESSMENT Nervous system disorders None View
UPPER RESPIRATORY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations None View
URINARY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations None View
UROSEPSIS SYSTEMATIC_ASSESSMENT Infections and infestations None View
VASCULAR GRAFT THROMBOSIS SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
VIRAL INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations None View
VOMITING SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
ABDOMINAL PAIN SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
ACCELERATED HYPERTENSION SYSTEMATIC_ASSESSMENT Vascular disorders None View
ACUTE MYOCARDIAL INFARCTION SYSTEMATIC_ASSESSMENT Cardiac disorders None View
ACUTE PULMONARY OEDEMA SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
ACUTE RESPIRATORY FAILURE SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
ANAEMIA OF CHRONIC DISEASE SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
ANAEMIA POSTOPERATIVE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
ANGINA PECTORIS SYSTEMATIC_ASSESSMENT Cardiac disorders None View
ANGINA UNSTABLE SYSTEMATIC_ASSESSMENT Cardiac disorders None View
ANXIETY SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
ARTERIOSCLEROSIS SYSTEMATIC_ASSESSMENT Vascular disorders None View
ARTERIOVENOUS FISTULA ANEURYSM SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
ARTERIOVENOUS FISTULA OCCLUSION SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
ARTERIOVENOUS FISTULA SITE COMPLICATION SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
ARTERIOVENOUS FISTULA SITE HAEMORRHAGE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
ARTERIOVENOUS FISTULA THROMBOSIS SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
ARTERIOVENOUS GRAFT SITE INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations None View
ATRIAL FIBRILLATION SYSTEMATIC_ASSESSMENT Cardiac disorders None View
ATRIAL FLUTTER SYSTEMATIC_ASSESSMENT Cardiac disorders None View
ATRIOVENTRICULAR BLOCK FIRST DEGREE SYSTEMATIC_ASSESSMENT Cardiac disorders None View
ATRIOVENTRICULAR BLOCK SECOND DEGREE SYSTEMATIC_ASSESSMENT Cardiac disorders None View
BACTERAEMIA SYSTEMATIC_ASSESSMENT Infections and infestations None View
BACK PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
CARDIAC ARREST SYSTEMATIC_ASSESSMENT Cardiac disorders None View
CARDIAC FAILURE CONGESTIVE SYSTEMATIC_ASSESSMENT Cardiac disorders None View
CARDIOGENIC SHOCK SYSTEMATIC_ASSESSMENT Cardiac disorders None View
CARDIOMYOPATHY SYSTEMATIC_ASSESSMENT Cardiac disorders None View
CARDIO-RESPIRATORY ARREST SYSTEMATIC_ASSESSMENT Cardiac disorders None View
CARDIOVERSION SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
CATHETER SITE HAEMATOMA SYSTEMATIC_ASSESSMENT General disorders None View
CELLULITIS SYSTEMATIC_ASSESSMENT Infections and infestations None View
CEREBROVASCULAR ACCIDENT SYSTEMATIC_ASSESSMENT Nervous system disorders None View
CERVICAL SPINAL STENOSIS SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
CERVIX CARCINOMA STAGE 0 SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
CHEST PAIN SYSTEMATIC_ASSESSMENT General disorders None View
CHILLS SYSTEMATIC_ASSESSMENT General disorders None View
CHOLANGITIS SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
CHONDROCALCINOSIS PYROPHOSPHATE SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
CLOSTRIDIUM DIFFICILE COLITIS SYSTEMATIC_ASSESSMENT Infections and infestations None View
COLORECTAL CANCER SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
COMMINUTED FRACTURE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
CONGESTIVE CARDIOMYOPATHY SYSTEMATIC_ASSESSMENT Cardiac disorders None View
CROHN'S DISEASE SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
DEATH SYSTEMATIC_ASSESSMENT General disorders None View
DECREASED APPETITE SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
DEEP VEIN THROMBOSIS SYSTEMATIC_ASSESSMENT Vascular disorders None View
DEHYDRATION SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
DEVICE DISLOCATION SYSTEMATIC_ASSESSMENT General disorders None View
DEVICE RELATED INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations None View
DIABETES MELLITUS INADEQUATE CONTROL SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
DIABETIC FOOT SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
DIARRHOEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
DIVERTICULITIS SYSTEMATIC_ASSESSMENT Infections and infestations None View
DIVERTICULUM INTESTINAL HAEMORRHAGIC SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
DIZZINESS SYSTEMATIC_ASSESSMENT Nervous system disorders None View
DYSPHAGIA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
ENCEPHALOPATHY SYSTEMATIC_ASSESSMENT Nervous system disorders None View
ENDOCARDITIS SYSTEMATIC_ASSESSMENT Infections and infestations None View
ENDOMETRIAL HYPERPLASIA SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
FACIAL BONES FRACTURE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
FLUID OVERLOAD SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
GANGRENE SYSTEMATIC_ASSESSMENT Infections and infestations None View
GASTRITIS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
GASTRITIS EROSIVE SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
GASTROENTERITIS SYSTEMATIC_ASSESSMENT Infections and infestations None View
HAEMANGIOMA OF LIVER SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
HEAD INJURY SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
HEADACHE SYSTEMATIC_ASSESSMENT Nervous system disorders None View
HEPATIC ENCEPHALOPATHY SYSTEMATIC_ASSESSMENT Nervous system disorders None View
HIP FRACTURE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
HYPERGLYCAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
HYPERKALAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
HYPERPARATHYROIDISM SECONDARY SYSTEMATIC_ASSESSMENT Endocrine disorders None View
HYPERTENSION SYSTEMATIC_ASSESSMENT Vascular disorders None View
HYPERTENSIVE CRISIS SYSTEMATIC_ASSESSMENT Vascular disorders None View
HYPERTENSIVE EMERGENCY SYSTEMATIC_ASSESSMENT Vascular disorders None View
HYPERTENSIVE ENCEPHALOPATHY SYSTEMATIC_ASSESSMENT Nervous system disorders None View
HYPOGLYCAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
HYPOTENSION SYSTEMATIC_ASSESSMENT Vascular disorders None View
HYPOVOLAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
INFECTED SKIN ULCER SYSTEMATIC_ASSESSMENT Infections and infestations None View
INTRACARDIAC THROMBUS SYSTEMATIC_ASSESSMENT Cardiac disorders None View
LOBAR PNEUMONIA SYSTEMATIC_ASSESSMENT Infections and infestations None View
LOSS OF CONSCIOUSNESS SYSTEMATIC_ASSESSMENT Nervous system disorders None View
LOWER GASTROINTESTINAL HAEMORRHAGE SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
MENTAL STATUS CHANGES SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
METABOLIC ENCEPHALOPATHY SYSTEMATIC_ASSESSMENT Nervous system disorders None View
MUSCLE RUPTURE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
MUSCLE STRAIN SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
MUSCULOSKELETAL CHEST PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
MYOCARDIAL INFARCTION SYSTEMATIC_ASSESSMENT Cardiac disorders None View
NAUSEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
NON-CARDIAC CHEST PAIN SYSTEMATIC_ASSESSMENT General disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
ABDOMINAL PAIN UPPER SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
ANAEMIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
ANGINA PECTORIS SYSTEMATIC_ASSESSMENT Cardiac disorders None View
ARTERIOVENOUS FISTULA SITE COMPLICATION SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
ARTERIOVENOUS FISTULA SITE HAEMORRHAGE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
ARTERIOVENOUS FISTULA THROMBOSIS SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
ARTHRALGIA SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
ASTHENIA SYSTEMATIC_ASSESSMENT General disorders None View
BACK PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
CONSTIPATION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
COUGH SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
DECREASED APPETITE SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
DIARRHOEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
DIZZINESS SYSTEMATIC_ASSESSMENT Nervous system disorders None View
DYSPNOEA SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
FATIGUE SYSTEMATIC_ASSESSMENT General disorders None View
FLUID OVERLOAD SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
HAEMODIALYSIS-INDUCED SYMPTOM SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
HEADACHE SYSTEMATIC_ASSESSMENT Nervous system disorders None View
HYPERKALAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
HYPERTENSION SYSTEMATIC_ASSESSMENT Vascular disorders None View
HYPOAESTHESIA SYSTEMATIC_ASSESSMENT Nervous system disorders None View
INSOMNIA SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
MALAISE SYSTEMATIC_ASSESSMENT General disorders None View
MUSCLE SPASMS SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
MUSCULOSKELETAL PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
NASOPHARYNGITIS SYSTEMATIC_ASSESSMENT Infections and infestations None View
NAUSEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
NON-CARDIAC CHEST PAIN SYSTEMATIC_ASSESSMENT General disorders None View
OEDEMA PERIPHERAL SYSTEMATIC_ASSESSMENT General disorders None View
PAIN SYSTEMATIC_ASSESSMENT General disorders None View
PAIN IN EXTREMITY SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
PROCEDURAL DIZZINESS SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
PROCEDURAL HYPOTENSION SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
PYREXIA SYSTEMATIC_ASSESSMENT General disorders None View
THROMBOSIS IN DEVICE SYSTEMATIC_ASSESSMENT General disorders None View
UPPER RESPIRATORY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations None View
URINARY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations None View
VASCULAR GRAFT COMPLICATION SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
VITAMIN D DEFICIENCY SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
VOMITING SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View