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 |
|---|---|---|---|---|---|---|---|---|
| RIC HSCT, GVHD Prophylaxis | RIC: Patients receive fludarabine phosphate IV on days -10 to -8 and cyclophosphamide IV on days -3 and -2. Patients also undergo TBI followed by a DLI on day -6. TRANSPLANT: Patients undergo CD34+ peripheral blood stem cell transplant on day 0. GVHD PROPHYLAXIS: Patients receive tacrolimus PO beginning day -1 with a taper initiated on day 42 and mycophenolate mofetil IV BID on days -1 to 28 in the absence of GVHD. Fludarabine: Given IV Total-Body Irradiation: Undergo TBI T Cell-Depleted Donor Lymphocyte Infusion: Undergo DLI Cyclophosphamide: Given IV Peripheral Blood Stem Cell Transplantation: Undergo PBSC transplant Allogeneic Hematopoietic Stem Cell Transplantation: Undergo PBSC transplant Tacrolimus: Given PO Mycophenolate mofetil: Given IV Laboratory Biomarker Analysis: Correlative studies | 1 | None | 10 | 35 | 33 | 35 | View |
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Cardiac Arrest | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Hepatobiliary disorder | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | None | View |
| Nervous System disorder- Aphasia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Abdominal Pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Acute Kidney Injury | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| ALT increased | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Bilirubin increased | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Cholecystitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Cognitive disturbance | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Deliurm | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Depressed level of Consciousness | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Ejection Fraction decreased | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Fever | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Hematuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| hypoxia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Infection & Infestations- Other fever | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Lung Infection | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | None | View |
| Pneumonitis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| SVT | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Syncope | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Urinary Tract Infection | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Urinary Tract Infection | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Somnolence | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Shortness of breath | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Sexual dysfunction | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| sore throat | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Skin peeling | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Rectal pain | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Respiratory, thoracic and mediastinal disorders- other, nasopharyngeal bleed | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Unspecified eye problem | SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| taste change | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| sleep disturbance | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| skin and subcutaneous tissue disorders- other, Pallor | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Infusion related reaction- headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Infections and infestations- other, HHV-6 | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Infections and infestations- other, CMV Viremia | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Infections and infestations- other, bacteremia | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Hyperkalemia | SYSTEMATIC_ASSESSMENT | Endocrine disorders | None | View |
| Hyperbilirubinemia | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | None | View |
| Generalized muscle weakness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Gastrointestinal disorders- other, "itchy" mouth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Generalized itching | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Hypervolemia | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Foot and Leg pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| decreased PO intake | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| ascites | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Wound-top of head | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Wound of Groin | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Wound on buttock | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Wheezing | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Weight loss | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Weakness | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| VRE | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Volume overload | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Vaginal cysts | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| UTI-VRE | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Urine incontinence | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| urinary retention | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Urinary frequency | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Trouble sleeping | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| tooth pain | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Tachypnea | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Stiff neck | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Sleep apnea | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Tinea Cruis | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Tinnitus | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | None | View |
| Vision changes | SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| Urinary tract pain | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Typhlitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Vitamin K deficiency | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Urticaria | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Trouble swallowing | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Unexpected weight change | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Tremor | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Thromboembolic event | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Thrush | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Throat pain | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| sleep apnea | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Supraventricular tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| tissue disorders- other, skin tear | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Skin and Subcutaneous tissue disorders-other, sacrum sore | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Skin and subcutaneous tissue disorders- other, erythema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Skin and subcutaneous tissue disorders- other, keratosis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| skin and subcutaneous tissue disorders- other, Folliculitis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Skin and subcutaneous tissue disorders, other excoriation | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Syncope | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Skin Hyperpigmentation | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Skin- Ashen color | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Sinus congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| sinus tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Sinus Bradycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Shoulder pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| subconjunctiva hemorrhage | SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| Skin induration | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| scalp pain | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Scrotal pain | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | None | View |
| Scrotal Edema | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | None | View |
| scleral disorder | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Right arm swelling | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Rhinorrhea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Rhinitis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Respiratory, thoracic and mediastinal disorders- other, rales | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Rash maculo-papular | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Rigors | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Renal and urinary disorders- other, dysuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Renal and Urinary disorders- hemorrhagic cystitis due to BK virus | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Reproductive system and breast disorders- other, scrotal edema | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | None | View |
| Renal and urinary disorders- other, decreased urine output | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Respiratory, thoracic and mediastinal disorders - other, tachypnea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Renal and Urinary disorders- other, difficulty urinating | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Premature Ventricular Contractions | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Pulmonary edema | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Pruritis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Pleural effusions | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Pericardial effusion | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Vasovagal reaction | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Skin and subcutaneous tissue disorders- other, diaphoretic | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Skin and subcutaneous disorders- other, pale | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| viral conjunctivitis | SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| sinus headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Paresthesia pain | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Palpitations | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Pain - general | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Pneumothorax | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Pleuritic pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Pneumonitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Parotiditis | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Physical deconditioning | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Psychiatric disorders- other, decreased concentration | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Pericarditis | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Peripheral neuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| peripheral edema | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| patchy spots on tongue | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Pruritic raised erythematous rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| polyuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Odynophagia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Night sweats | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Neuro-weakness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Neck Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Non- cardiac chest pain | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Nervous System Disorders- other, Altered MS with Aphasia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Neoplasms benign, malignant and unspecified (in cyss and polyps)- other, bump on left arm | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Nosebleeds | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Nocturia | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Nasal Congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Mucositis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| MRSA - skin lesion | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Musculoskeletal and connective tissue disorder- other, Charlie HOrse | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Musculoskeletal and connective tissue disorders- other, unsteadiness on feet | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Malaise | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Memory impairment | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Musculoskeletal and connective tissue disorders- other, physical deconditioning | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Muscle weakness in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Metabolism and nutrition disorders- electrolyte disturbances | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Mouth Sores | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Lung Infection | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | None | View |
| Lump on right forearm | SYSTEMATIC_ASSESSMENT | Endocrine disorders | None | View |
| Loss of smell/taste | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Loose Stools | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Lightheadedness | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Lethargy/Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Left pericatheter thrombus | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| LE edema | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Left Axilla swelling | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Itching | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Irregular heart ryhythm | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Infusion Related Reaction - rigors | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Infusion related reaction- Hypertension | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Infusion related reaction- chills | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| infusion related reaction | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Infection and Infestations- other (fever) | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Indigestion | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Increased LFT's | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | None | View |
| infections and infestations- other, CMV reactivation | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Infections and infestations- other, cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| increased creatinine | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Iron overload | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Injury, poisoning and procedural complications- other, wounds | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| injury, poisoning and procedural complications- other, scrotal bleeding | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| injury, poisoning and procedural complications- other, pressure ulcer | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| injury, poisoning and procedural complications- other, parotitis | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| injury, poisoning and procedural complications- other, GI bleeding | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Infusion related reaction- hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| injury, poisoning and procedural complications- other ecchymosis | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| infections and infestations- other, epididmoorchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| infections and infestations- other, covid-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| intermittent hyperglycemia | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| intermittent headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| intermittent fatigue | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| intermittent dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Vaginal Pain | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | None | View |
| Postnasal drip | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Phantom pain | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Oral Pain | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Metabolism and nutritional disorders- other, vitamin D deficiency | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Hypoxia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Hypothyroidism | SYSTEMATIC_ASSESSMENT | Endocrine disorders | None | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Hot flashes | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | None | View |
| Hive | SYSTEMATIC_ASSESSMENT | Immune system disorders | None | View |
| Hematuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Headache | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Hallucinations | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Hiccups | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Hematuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Hypomagnesemia | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Hypokalemia | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Hyperglycemia | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Hypothermia | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Hypophosphatemia | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Hyponatremia | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Hypernatremia | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Heel pain | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Hyperhidrosis | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Hoarsness | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| hemorrhoids | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Hyperphosphatemia | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| GERD | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| General Disorders and administration site conditions - other Diaphoresis | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| General disorders and administration site conditions- other, generalized aches | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Gastrointestinal disorders- other, Oral ulcer | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Gait Disturbance | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| General disorders and administration site conditions- other fluid overload | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Gatrointestinal disorders- other oral blister | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| General disorders and administration site disorders- other, night sweats | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| general disorders and administration site conditions- other, bleeding event | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| gastrointestinal pain | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| gastrointestinal disorders- other, Perirectal irritation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| gastrointestinal disorders- other, pain at PEG site | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| gastrointestinal disorders- other, hematochezia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Gastrointestinal disorders- other, tongue coating | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Flatulence | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Fever | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Flushing | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Floaters | SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Enterocolitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Elevated total bilirubin level | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | None | View |
| Elevated creatinine | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Ejection fraction decreased | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Edema | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Ecchymosis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Ear pain | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | None | View |
| Eye disorders - other, blind in right eye | SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| Eye infection | SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| Eye disorders, other Diplopia | SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| Excoriation - scrotum | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | None | View |
| Erythema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| ear and labyrinth disorders- other, ear fullness | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | None | View |
| eye disorders- other, farsightedness | SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| Extrapyramidal disorder | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Esophagitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Dysuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Dyspnea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| DVT | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Dry mouth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Dry Eyes | SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| Double vision | SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Distended stomach | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Discomfort at foley site | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Delirium | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Dry skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Diaphoresis | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Dysphagia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Dysgeusia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Distention | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| deconditioning | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| dehyrdration | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| cystitis noninfective | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Confusion | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| CMV reactivation | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| chills | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| chest tightness | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| chest pain | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Cardio disorders- other, murmur | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| crushingoid | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| cognitive disturbance | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| crackles at lung bases | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| cholelithiasis | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| cytomegalovirus viremia | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| burning sensation | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| blood bilirubin increased | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | None | View |
| bladder pressure | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| bibasilar atelectasis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| back pain and stiffness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| buttocks pain | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| bruising | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| bradycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| bloating | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| blood and lymphatic system disorders- other | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| bullous dermatitis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| blood blister | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| bone pain | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| bilateral pam itching | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| bilateral leg cramp | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| bilateral edema | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| awakening to urinate | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| asthma | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Alopecia | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Agitated/ Irritable | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Acidy mouth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Achiness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Abrasion | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| alkaline phosphate increased | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| abdominal distention | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| anorexia | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| acute kidney injury | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| aspiration | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Atrial Flutter | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| altered taste | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| atrial fibrillation RVR | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| acute diverticulitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| abdominal discomfort | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |