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
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Induction (All Patients) | All Patients for Induction (not assigned) | 6 | None | 9 | 210 | 181 | 210 | View |
| Post Induction (Follow-up Only) | Post-Induction patients that did not receive therapy | 6 | None | 0 | 12 | 5 | 12 | View |
| Arm C (Safety/ Dose Level 2) | Arm C, IR/HR MLL-R chemotherapy and lestaurtinib at Dose Level 2 (DL2) (HR: 4.25 mg/kg/day; SR: 5 mg/kg/day) | 5 | None | 7 | 11 | 11 | 11 | View |
| Arm A (Standard Risk MLL-G) | Population Description: Eligible patients with MLL-G (germline, or non-rearranged) Asparaginase: Given IV, IM, or PO Cyclophosphamide: Given IV Cytarabine: Given IV or IT Daunorubicin Hydrochloride: Given IV Dexamethasone: Given IV or PO Etoposide: Given IV Filgrastim: Given IV or SC Laboratory Biomarker Analysis: Correlative studies Leucovorin Calcium: Given IV Mercaptopurine: Given PO Methotrexate: Given IV, IT, or PO Methylprednisolone: Given IV Pegaspargase: Given IM Pharmacological Study: Correlative studies Prednisone: Given PO Therapeutic Hydrocortisone: Given IT Vincristine Sulfate: Given IV | 3 | None | 2 | 60 | 59 | 60 | View |
| Arm B (IR/HR MLL-R Chemotherapy) | Population Description: Eligible patients with MLL-R (rearranged). Considered Intermediate Risk (IR) if age \>= 90 days at diagnosis and High Risk (HR) if age \< 90 days at diagnosis. Asparaginase: Given IV, IM, or PO Cyclophosphamide: Given IV Cytarabine: Given IV or IT Daunorubicin Hydrochloride: Given IV Dexamethasone: Given IV or PO Etoposide: Given IV Filgrastim: Given IV or SC Laboratory Biomarker Analysis: Correlative studies Leucovorin Calcium: Given IV Mercaptopurine: Given PO Methotrexate: Given IV, IT, or PO Methylprednisolone: Given IV Pegaspargase: Given IM Pharmacological Study: Correlative studies Prednisone: Given PO Therapeutic Hydrocortisone: Given IT Vincristine Sulfate: Given IV | 31 | None | 9 | 54 | 54 | 54 | View |
| Arm C (Safety/ Dose Level 1) | Arm C, IR/HR MLL-R chemotherapy and lestaurtinib at Dose Level 1 (DL1) (HR: 3.5 mg/kg/day; SR: 4 mg/kg/day) | 6 | None | 8 | 11 | 11 | 11 | View |
| Arm C (Efficacy/ Dose Level 2) | Arm C, IR/HR MLL-R chemotherapy and lestaurtinib at Dose Level 2 (DL2)-Efficacy (HR: 4.25 mg/kg/day; SR: 5 mg/kg/day) | 28 | None | 41 | 56 | 55 | 56 | View |
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCv4 | View |
| Blood and lymphatic system disorders - Other, specify | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCv4 | View |
| Febrile neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCv4 | View |
| Hemolytic uremic syndrome | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCv4 | View |
| Thrombotic thrombocytopenic purpura | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCv4 | View |
| Cardiac arrest | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCv4 | View |
| Heart failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCv4 | View |
| Gastrointestinal fistula | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCv4 | View |
| Lower gastrointestinal hemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCv4 | View |
| Irritability | SYSTEMATIC_ASSESSMENT | General disorders | CTCv4 | View |
| Enterocolitis infectious | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCv4 | View |
| Hepatic infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCv4 | View |
| Infections and infestations - Other, specify | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCv4 | View |
| Lung infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCv4 | View |
| GGT increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCv4 | View |
| Left ventricular systolic dysfunction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCv4 | View |
| Myocarditis | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCv4 | View |
| Sinus tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCv4 | View |
| Ascites | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCv4 | View |
| Colitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCv4 | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCv4 | View |
| Enterocolitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCv4 | View |
| Gastric hemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCv4 | View |
| Gastrointestinal disorders - Other, specify | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCv4 | View |
| Mucositis oral | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCv4 | View |
| Oral pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCv4 | View |
| Small intestinal perforation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCv4 | View |
| Typhlitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCv4 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCv4 | View |
| Death NOS | SYSTEMATIC_ASSESSMENT | General disorders | CTCv4 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | CTCv4 | View |
| Fever | SYSTEMATIC_ASSESSMENT | General disorders | CTCv4 | View |
| General disorders and administration site conditions - Other, specify | SYSTEMATIC_ASSESSMENT | General disorders | CTCv4 | View |
| Multi-organ failure | SYSTEMATIC_ASSESSMENT | General disorders | CTCv4 | View |
| Anaphylaxis | SYSTEMATIC_ASSESSMENT | Immune system disorders | CTCv4 | View |
| Immune system disorders - Other, specify | SYSTEMATIC_ASSESSMENT | Immune system disorders | CTCv4 | View |
| Abdominal infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCv4 | View |
| Anorectal infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCv4 | View |
| Bronchial infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCv4 | View |
| Catheter related infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCv4 | View |
| Endocarditis infective | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCv4 | View |
| Mucosal infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCv4 | View |
| Peritoneal infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCv4 | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCv4 | View |
| Skin infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCv4 | View |
| Small intestine infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCv4 | View |
| Soft tissue infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCv4 | View |
| Tracheitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCv4 | View |
| Upper respiratory infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCv4 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCv4 | View |
| Wound infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCv4 | View |
| Injury, poisoning and procedural complications - Other, specify | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCv4 | View |
| Vascular access complication | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCv4 | View |
| Activated partial thromboplastin time prolonged | SYSTEMATIC_ASSESSMENT | Investigations | CTCv4 | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCv4 | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCv4 | View |
| Blood bilirubin increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCv4 | View |
| Creatinine increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCv4 | View |
| Fibrinogen decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCv4 | View |
| Investigations - Other, specify | SYSTEMATIC_ASSESSMENT | Investigations | CTCv4 | View |
| Lipase increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCv4 | View |
| Lymphocyte count decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCv4 | View |
| Neutrophil count decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCv4 | View |
| Platelet count decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCv4 | View |
| Weight loss | SYSTEMATIC_ASSESSMENT | Investigations | CTCv4 | View |
| White blood cell decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCv4 | View |
| Acidosis | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv4 | View |
| Anorexia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv4 | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv4 | View |
| Hyperglycemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv4 | View |
| Hypernatremia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv4 | View |
| Hypertriglyceridemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv4 | View |
| Hypoalbuminemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv4 | View |
| Hypocalcemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv4 | View |
| Hypoglycemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv4 | View |
| Hypokalemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv4 | View |
| Hyponatremia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv4 | View |
| Hypophosphatemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv4 | View |
| Treatment related secondary malignancy | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCv4 | View |
| Abducens nerve disorder | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCv4 | View |
| Cognitive disturbance | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCv4 | View |
| Depressed level of consciousness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCv4 | View |
| Encephalopathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCv4 | View |
| Oculomotor nerve disorder | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCv4 | View |
| Seizure | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCv4 | View |
| Stroke | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCv4 | View |
| Psychiatric disorders - Other, specify | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCv4 | View |
| Acute kidney injury | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCv4 | View |
| Adult respiratory distress syndrome | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCv4 | View |
| Apnea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCv4 | View |
| Aspiration | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCv4 | View |
| Atelectasis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCv4 | View |
| Dyspnea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCv4 | View |
| Hypoxia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCv4 | View |
| Pneumonitis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCv4 | View |
| Respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCv4 | View |
| Rash maculo-papular | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCv4 | View |
| Skin and subcutaneous tissue disorders - Other, specify | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCv4 | View |
| Skin ulceration | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCv4 | View |
| Surgical and medical procedures - Other, specify | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | CTCv4 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCv4 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCv4 | View |
| Thromboembolic event | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCv4 | View |
| Visceral arterial ischemia | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCv4 | View |
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Metabolism and nutrition disorders - Other, specify | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv4 | View |
| Generalized muscle weakness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCv4 | View |
| Muscle weakness trunk | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCv4 | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCv4 | View |
| Leukemia secondary to oncology chemotherapy | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCv4 | View |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCv4 | View |
| Encephalopathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCv4 | View |
| Intracranial hemorrhage | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCv4 | View |
| Nervous system disorders - Other, specify | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCv4 | View |
| Peripheral motor neuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCv4 | View |
| Peripheral sensory neuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCv4 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCv4 | View |
| Penile pain | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | CTCv4 | View |
| Adult respiratory distress syndrome | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCv4 | View |
| Atelectasis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCv4 | View |
| Bronchopulmonary hemorrhage | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCv4 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCv4 | View |
| Dyspnea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCv4 | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCv4 | View |
| Hypoxia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCv4 | View |
| Laryngeal mucositis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCv4 | View |
| Pharyngeal mucositis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCv4 | View |
| Pleural effusion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCv4 | View |
| Anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCv4 | View |
| Blood and lymphatic system disorders - Other, specify | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCv4 | View |
| Disseminated intravascular coagulation | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCv4 | View |
| Febrile neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCv4 | View |
| Leukocytosis | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCv4 | View |
| Cardiac arrest | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCv4 | View |
| Cardiac disorders - Other, specify | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCv4 | View |
| Myocarditis | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCv4 | View |
| Sinus tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCv4 | View |
| Blurred vision | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCv4 | View |
| Eye disorders - Other, specify | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCv4 | View |
| Abdominal distension | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCv4 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCv4 | View |
| Anal mucositis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCv4 | View |
| Anal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCv4 | View |
| Colitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCv4 | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCv4 | View |
| Dysphagia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCv4 | View |
| Enterocolitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCv4 | View |
| Esophagitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCv4 | View |
| Gastric hemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCv4 | View |
| Gastritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCv4 | View |
| Gastrointestinal disorders - Other, specify | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCv4 | View |
| Mucositis oral | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCv4 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCv4 | View |
| Oral hemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCv4 | View |
| Oral pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCv4 | View |
| Rectal mucositis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCv4 | View |
| Small intestinal mucositis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCv4 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCv4 | View |
| Death NOS | SYSTEMATIC_ASSESSMENT | General disorders | CTCv4 | View |
| Edema face | SYSTEMATIC_ASSESSMENT | General disorders | CTCv4 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | CTCv4 | View |
| Fever | SYSTEMATIC_ASSESSMENT | General disorders | CTCv4 | View |
| General disorders and administration site conditions - Other, specify | SYSTEMATIC_ASSESSMENT | General disorders | CTCv4 | View |
| Hypothermia | SYSTEMATIC_ASSESSMENT | General disorders | CTCv4 | View |
| Infusion related reaction | SYSTEMATIC_ASSESSMENT | General disorders | CTCv4 | View |
| Irritability | SYSTEMATIC_ASSESSMENT | General disorders | CTCv4 | View |
| Multi-organ failure | SYSTEMATIC_ASSESSMENT | General disorders | CTCv4 | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | CTCv4 | View |
| Hepatic failure | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | CTCv4 | View |
| Allergic reaction | SYSTEMATIC_ASSESSMENT | Immune system disorders | CTCv4 | View |
| Anaphylaxis | SYSTEMATIC_ASSESSMENT | Immune system disorders | CTCv4 | View |
| Immune system disorders - Other, specify | SYSTEMATIC_ASSESSMENT | Immune system disorders | CTCv4 | View |
| Anorectal infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCv4 | View |
| Bladder infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCv4 | View |
| Bronchial infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCv4 | View |
| Catheter related infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCv4 | View |
| Endocarditis infective | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCv4 | View |
| Enterocolitis infectious | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCv4 | View |
| Infections and infestations - Other, specify | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCv4 | View |
| Lung infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCv4 | View |
| Meningitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCv4 | View |
| Mucosal infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCv4 | View |
| Otitis media | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCv4 | View |
| Paronychia | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCv4 | View |
| Penile infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCv4 | View |
| Pharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCv4 | View |
| Rash pustular | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCv4 | View |
| Scrotal infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCv4 | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCv4 | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCv4 | View |
| Skin infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCv4 | View |
| Small intestine infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCv4 | View |
| Soft tissue infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCv4 | View |
| Upper respiratory infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCv4 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCv4 | View |
| Vulval infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCv4 | View |
| Wound infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCv4 | View |
| Fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCv4 | View |
| Intraoperative hemorrhage | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCv4 | View |
| Vascular access complication | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCv4 | View |
| Wound complication | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCv4 | View |
| Activated partial thromboplastin time prolonged | SYSTEMATIC_ASSESSMENT | Investigations | CTCv4 | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCv4 | View |
| Alkaline phosphatase increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCv4 | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCv4 | View |
| Blood bilirubin increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCv4 | View |
| Creatinine increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCv4 | View |
| GGT increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCv4 | View |
| Investigations - Other, specify | SYSTEMATIC_ASSESSMENT | Investigations | CTCv4 | View |
| Lipase increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCv4 | View |
| Lymphocyte count decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCv4 | View |
| Neutrophil count decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCv4 | View |
| Platelet count decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCv4 | View |
| Urine output decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCv4 | View |
| Weight gain | SYSTEMATIC_ASSESSMENT | Investigations | CTCv4 | View |
| Weight loss | SYSTEMATIC_ASSESSMENT | Investigations | CTCv4 | View |
| White blood cell decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCv4 | View |
| Acidosis | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv4 | View |
| Anorexia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv4 | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv4 | View |
| Hypercalcemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv4 | View |
| Hyperglycemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv4 | View |
| Hyperkalemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv4 | View |
| Hypernatremia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv4 | View |
| Hypertriglyceridemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv4 | View |
| Hypoalbuminemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv4 | View |
| Hypocalcemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv4 | View |
| Hypoglycemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv4 | View |
| Hypokalemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv4 | View |
| Hypomagnesemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv4 | View |
| Hyponatremia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv4 | View |
| Hypophosphatemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv4 | View |
| Acute kidney injury | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCv4 | View |
| Hematuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCv4 | View |
| Renal and urinary disorders - Other, specify | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCv4 | View |
| Pneumonitis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCv4 | View |
| Pneumothorax | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCv4 | View |
| Pulmonary edema | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCv4 | View |
| Respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCv4 | View |
| Respiratory, thoracic and mediastinal disorders - Other, specify | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCv4 | View |
| Sinus disorder | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCv4 | View |
| Stridor | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCv4 | View |
| Dry skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCv4 | View |
| Erythema multiforme | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCv4 | View |
| Pain of skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCv4 | View |
| Periorbital edema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCv4 | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCv4 | View |
| Rash maculo-papular | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCv4 | View |
| Skin and subcutaneous tissue disorders - Other, specify | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCv4 | View |
| Skin induration | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCv4 | View |
| Skin ulceration | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCv4 | View |
| Surgical and medical procedures - Other, specify | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | CTCv4 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCv4 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCv4 | View |
| Thromboembolic event | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCv4 | View |
| Vascular disorders - Other, specify | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCv4 | View |