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: 2025-12-24 @ 12:44 PM
Ignite Modification Date: 2025-12-25 @ 12:14 PM
NCT ID: NCT04802161
Description: None
Frequency Threshold: 5
Time Frame: Up to 30 days after last dose, up to 2 years
Study: NCT04802161
Study Brief: Comparing the Addition of an Anti-Cancer Drug, Pomalidomide, to the Usual Chemotherapy Treatment (Daunorubicin and Cytarabine Liposome) in Newly Diagnosed Acute Myeloid Leukemia With Myelodysplastic Syndrome-Related Changes
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Safety Run In DL1 (14 Days Pomalidomide) Patients receive liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1, 3, and 5 and then pomalidomide PO QD beginning between days 21-30 for 14 days in the absence of disease progression or unacceptable toxicity. Patients who do not respond, may receive a second cycle of liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1 and 3 in the absence of disease progression or unacceptable toxicity. CONSOLIDATION: Patients who achieve CR/CRi receive liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1 and 3. Treatment repeats every 21 days for 2 cycles in the absence of disease progression and unacceptable toxicity. Patients also undergo bone marrow aspirate and biopsy and collection of blood samples throughout all phases of the trial. Biospecimen Collection: Undergo collection of blood samples Bone Marrow Aspiration and Biopsy: Undergo bone marrow aspirate and biopsy Liposome-encapsulated Daunorubicin-Cytarabine: Given IV Pomalidomide: Given PO 3 None 7 7 7 7 View
Safety Run In DL-1 (10 Days Pomalidomide) Patients receive liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1, 3, and 5 and then pomalidomide PO QD beginning between days 21-30 for 10 days in the absence of disease progression or unacceptable toxicity. Patients who do not respond, may receive a second cycle of liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1 and 3 in the absence of disease progression or unacceptable toxicity. CONSOLIDATION: Patients who achieve CR/CRi receive liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1 and 3. Treatment repeats every 21 days for 2 cycles in the absence of disease progression and unacceptable toxicity. Patients also undergo bone marrow aspirate and biopsy and collection of blood samples throughout all phases of the trial. Biospecimen Collection: Undergo collection of blood samples Bone Marrow Aspiration and Biopsy: Undergo bone marrow aspirate and biopsy Liposome-encapsulated Daunorubicin-Cytarabine: Given IV Pomalidomide: Given PO 2 None 3 3 3 3 View
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) INDUCTION: Patients receive liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1, 3, and 5 and then pomalidomide PO QD beginning between days 21-30 for 14 days in the absence of disease progression or unacceptable toxicity. Patients who do not respond, may receive a second cycle of liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1 and 3 in the absence of disease progression or unacceptable toxicity. CONSOLIDATION: Patients who achieve CR/CRi receive liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1 and 3. Treatment repeats every 21 days for 2 cycles in the absence of disease progression and unacceptable toxicity. Patients also undergo bone marrow aspirate and biopsy and collection of blood samples throughout all phases of the trial. Biospecimen Collection: Undergo collection of blood samples Bone Marrow Aspiration and Biopsy: Undergo bone marrow aspirate and biopsy Liposome-encapsulated Daunorubicin-Cytarabine: Given IV Pomalidomide: Given PO 11 None 19 20 20 20 View
Arm B (Daunorubicin and Cytarabine Liposome) INDUCTION: Patients receive liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1, 3, and 5 in the absence of disease progression or unacceptable toxicity. Patients who do not respond, may receive a second cycle of liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1 and 3 in the absence of disease progression or unacceptable toxicity. CONSOLIDATION: Patients who achieve CR/CRi receive liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1 and 3. Treatment repeats every 21 days for 2 cycles in the absence of disease progression and unacceptable toxicity. Patients also undergo bone marrow aspirate and biopsy and collection of blood samples throughout all phases of the trial. Biospecimen Collection: Undergo collection of blood samples Bone Marrow Aspiration and Biopsy: Undergo bone marrow aspirate and biopsy Liposome-encapsulated Daunorubicin-Cytarabine: Given IV 7 None 19 19 18 19 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Alanine Aminotransferase Increased SYSTEMATIC_ASSESSMENT Investigations CTCAE v.5.0 View
Acute Respiratory Distress Syndrome (ARDS) SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v.5.0 View
Aspartate Aminotransferase Increased SYSTEMATIC_ASSESSMENT Investigations CTCAE v.5.0 View
Abdominal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v.5.0 View
Alkaline Phosphatase Increased SYSTEMATIC_ASSESSMENT Investigations CTCAE v.5.0 View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE v.5.0 View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v.5.0 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE v.5.0 View
Eosinophilia SYSTEMATIC_ASSESSMENT Investigations CTCAE v.5.0 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v.5.0 View
Eye disorders - Other, specify - Right eye vision lost SYSTEMATIC_ASSESSMENT Eye disorders CTCAE v.5.0 View
Fall SYSTEMATIC_ASSESSMENT General disorders CTCAE v.5.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE v.5.0 View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE v.5.0 View
GI disorders - Other, specify - melena SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v.5.0 View
GI disorders - Other, specify - Diverticulitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v.5.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE v.5.0 View
Hypoalbuminemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v.5.0 View
Hypocalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v.5.0 View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v.5.0 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE v.5.0 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v.5.0 View
Infections & infestations - Other - Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE v.5.0 View
Lung Infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE v.5.0 View
Lymphocyte Count Decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE v.5.0 View
Lymphocyte Count Increased SYSTEMATIC_ASSESSMENT Investigations CTCAE v.5.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v.5.0 View
Neutrophil Count Decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE v.5.0 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE v.5.0 View
Pleural Effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v.5.0 View
Pulmonary Edema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v.5.0 View
Rash Maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v.5.0 View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE v.5.0 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE v.5.0 View
Sinus bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE v.5.0 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE v.5.0 View
Skin Infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE v.5.0 View
Soft Tissue Infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE v.5.0 View
Supraventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE v.5.0 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE v.5.0 View
Typhlitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v.5.0 View
Upper Gastrointestinal Hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v.5.0 View
Urinary Retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE v.5.0 View
Vascular Access Complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE v.5.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v.5.0 View
White Blood Cell Decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE v.5.0 View
Activated Partial Thromboplastin Time Prolonged SYSTEMATIC_ASSESSMENT Investigations CTCAE v.5.0 View
Acute Kidney Injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE v.5.0 View
Atrial Fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE v.5.0 View
Atrial Flutter SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE v.5.0 View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations CTCAE v.5.0 View
Cardiac arrest SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE v.5.0 View
Catheter related infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE v.5.0 View
Creatinine increased SYSTEMATIC_ASSESSMENT Investigations CTCAE v.5.0 View
Delirium SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE v.5.0 View
Disease Progression SYSTEMATIC_ASSESSMENT General disorders CTCAE v.5.0 View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v.5.0 View
EKG QT corrected interval prolonged SYSTEMATIC_ASSESSMENT Investigations CTCAE v.5.0 View
Heart failure SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE v.5.0 View
Hematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE v.5.0 View
Hyperkalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v.5.0 View
Rectal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v.5.0 View
Renal Calculi SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE v.5.0 View
Respiratory Failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v.5.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Alanine Aminotransferase Increased SYSTEMATIC_ASSESSMENT Investigations CTCAE v.5.0 View
Aspartate Aminotransferase Increased SYSTEMATIC_ASSESSMENT Investigations CTCAE v.5.0 View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v.5.0 View
Abdominal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v.5.0 View
Activated Partial Thromboplastin Time Prolonged SYSTEMATIC_ASSESSMENT Investigations CTCAE v.5.0 View
Acute Kidney Injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE v.5.0 View
Alkaline Phosphatase Increased SYSTEMATIC_ASSESSMENT Investigations CTCAE v.5.0 View
Alkalosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v.5.0 View
Allergic Reaction SYSTEMATIC_ASSESSMENT Immune system disorders CTCAE v.5.0 View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v.5.0 View
Anal Fissure SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v.5.0 View
Anal Fistula SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v.5.0 View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE v.5.0 View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v.5.0 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE v.5.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE v.5.0 View
Arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE v.5.0 View
Atrial Fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE v.5.0 View
Atrial Flutter SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE v.5.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE v.5.0 View
Bacteremia SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE v.5.0 View
Bloating SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v.5.0 View
Blood Bicarbonate Decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE v.5.0 View
Blood Bilirubin Increased SYSTEMATIC_ASSESSMENT Investigations CTCAE v.5.0 View
Blood/Lymph - Other - D Dimer increased SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE v.5.0 View
Blood/Lymph - Other - Increased Fibrinogen SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE v.5.0 View
Blood/Lymph - Other - Prothrombin Time increased SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE v.5.0 View
Blood/Lymph - Other - febrile non-hemolytic transfusion reaction (FNHTR) SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE v.5.0 View
Blood/Lymph - Other - petechiae SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE v.5.0 View
Blurred Vision SYSTEMATIC_ASSESSMENT Eye disorders CTCAE v.5.0 View
Bone Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE v.5.0 View
Bruising SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE v.5.0 View
Cardiac Troponin I Increased SYSTEMATIC_ASSESSMENT Investigations CTCAE v.5.0 View
Catheter Related Infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE v.5.0 View
Chest Wall Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE v.5.0 View
Chills SYSTEMATIC_ASSESSMENT General disorders CTCAE v.5.0 View
Chronic Kidney Disease SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE v.5.0 View
Confusion SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE v.5.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v.5.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v.5.0 View
Creatinine Increased SYSTEMATIC_ASSESSMENT Investigations CTCAE v.5.0 View
Cytokine Release Syndrome SYSTEMATIC_ASSESSMENT Immune system disorders CTCAE v.5.0 View
Disseminated Intravascular Coagulation (DIC) SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE v.5.0 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v.5.0 View
Delirium SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE v.5.0 View
Delusions SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE v.5.0 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE v.5.0 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v.5.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE v.5.0 View
Dry Mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v.5.0 View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE v.5.0 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v.5.0 View
Dysphagia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v.5.0 View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v.5.0 View
EKG QT corrected interval prolong SYSTEMATIC_ASSESSMENT Investigations CTCAE v.5.0 View
Ear and Labyrinth - Other - Serous otitis media SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders CTCAE v.5.0 View
Ear Pain SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders CTCAE v.5.0 View
Edema Face SYSTEMATIC_ASSESSMENT General disorders CTCAE v.5.0 View
Edema limbs SYSTEMATIC_ASSESSMENT General disorders CTCAE v.5.0 View
Elevated Lactate Dehydrogenase SYSTEMATIC_ASSESSMENT Investigations CTCAE v.5.0 View
Eosinophilia SYSTEMATIC_ASSESSMENT Investigations CTCAE v.5.0 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v.5.0 View
Esophageal hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v.5.0 View
Extrapyramidal disorder SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE v.5.0 View
Fall SYSTEMATIC_ASSESSMENT General disorders CTCAE v.5.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE v.5.0 View
Febrile Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE v.5.0 View
Fever SYSTEMATIC_ASSESSMENT General disorders CTCAE v.5.0 View
Fibrinogen decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE v.5.0 View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v.5.0 View
Floaters SYSTEMATIC_ASSESSMENT Eye disorders CTCAE v.5.0 View
Flushing SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE v.5.0 View
Folliculitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v.5.0 View
Gamma-Glutamyl Transferase Increased SYSTEMATIC_ASSESSMENT Investigations CTCAE v.5.0 View
GI disorders - Other, specify - Black lesion on tongue SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v.5.0 View
GI disorders - Other, specify - Bright red blood per rectum SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v.5.0 View
GI disorders - Other, specify - Diverticulitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v.5.0 View
GI disorders - Other, specify - Gastrointestinal bleeding SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v.5.0 View
GI disorders - Other, specify - Genitourinary bleeding SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v.5.0 View
GI disorders - Other, specify - Gum Bleeding SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v.5.0 View
GI disorders - Other, specify - Lip lesion SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v.5.0 View
GI disorders - Other, specify - Lower GI hemmorrage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v.5.0 View
GI disorders - Other, specify - Melena SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v.5.0 View
GI disorders - Other, specify - Rectal bleeding SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v.5.0 View
GI disorders - Other, specify - Wet Purpura SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v.5.0 View
GI disorders - Other, specify - hematochezia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v.5.0 View
Gastroesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v.5.0 View
Gastrointestinal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v.5.0 View
Generalized Edema SYSTEMATIC_ASSESSMENT General disorders CTCAE v.5.0 View
Generalized muscle weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE v.5.0 View
Genital Edema SYSTEMATIC_ASSESSMENT General disorders CTCAE v.5.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE v.5.0 View
Hearing Impaired SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders CTCAE v.5.0 View
Heart Failure SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE v.5.0 View
Hematoma SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE v.5.0 View
Hematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE v.5.0 View
Hemorrhoidal hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v.5.0 View
Hemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v.5.0 View
Hoarsenes SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v.5.0 View
Hypercalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v.5.0 View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v.5.0 View
Hyperhidrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v.5.0 View
Hyperkalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v.5.0 View
Hypermagnesemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v.5.0 View
Hypernatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v.5.0 View
Hyperphosphatemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v.5.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE v.5.0 View
Hyperuricemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v.5.0 View
Hypoalbuminemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v.5.0 View
Hypocalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v.5.0 View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v.5.0 View
Hypomagnesemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v.5.0 View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v.5.0 View
Hypophospatemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v.5.0 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE v.5.0 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v.5.0 View
International Normalized Ratio (INR) Increased SYSTEMATIC_ASSESSMENT Investigations CTCAE v.5.0 View
Infections & infestations - Other - Pediculosis captis SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE v.5.0 View
Infections & infestations - Other - Sars-COV-2 SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE v.5.0 View
Infections & infestations - Other - Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE v.5.0 View
Infusion related reaction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE v.5.0 View
Injury/poison/procedure - Other - Acute RLE DVT SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE v.5.0 View
Injury/poison/procedure - Other - Acute RUE VTE (superficial and deep) SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE v.5.0 View
Injury/poison/procedure - Other - Central line incision site erythema SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE v.5.0 View
Injury/poison/procedure - Other - L maxillary anterior, medial, posterior wall fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE v.5.0 View
Injury/poison/procedure - Other - L nasal dorsum laceration SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE v.5.0 View
Injury/poison/procedure - Other - Left lateral orbital wall fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE v.5.0 View
Injury/poison/procedure - Other - R orbital roof/lateral orbital wall fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE v.5.0 View
Injury/poison/procedure - Other - Septal fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE v.5.0 View
Injury/poison/procedure - Other - bilateral nasal bone fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE v.5.0 View
Injury/poison/procedure - Other - left frontal bone fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE v.5.0 View
Injury/poison/procedure - Other - left inferior orbital wall fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE v.5.0 View
Injury/poison/procedure - Other - left supraorbital laceration SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE v.5.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE v.5.0 View
Investigations - Other, specify - Hyperfibrinogenemia SYSTEMATIC_ASSESSMENT Investigations CTCAE v.5.0 View
Investigations - Other, specify - Increased Fibrinogen SYSTEMATIC_ASSESSMENT Investigations CTCAE v.5.0 View
Investigations - Other, specify - increased chloride SYSTEMATIC_ASSESSMENT Investigations CTCAE v.5.0 View
Localized edema SYSTEMATIC_ASSESSMENT General disorders CTCAE v.5.0 View
Lung Infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE v.5.0 View
Lymph Node Pain SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE v.5.0 View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE v.5.0 View
Lymphocyte count increased SYSTEMATIC_ASSESSMENT Investigations CTCAE v.5.0 View
Mucositis oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v.5.0 View
Muscle cramp SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE v.5.0 View
Muscle weakness upper limb SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE v.5.0 View
Musculoskel/connect tissue -Other - Blanchable tissue (Buttocks) SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE v.5.0 View
Musculoskel/connect tissue -Other - Deep tissue injury (buttocks) SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE v.5.0 View
Musculoskel/connect tissue -Other - Pain in LLE SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE v.5.0 View
Musculoskel/connect tissue -Other - vastus lateralis muscle strain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE v.5.0 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE v.5.0 View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v.5.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v.5.0 View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE v.5.0 View
Nervous system - Other - Anomia SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE v.5.0 View
Nervous system - Other - Rigors SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE v.5.0 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE v.5.0 View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders CTCAE v.5.0 View
Oral hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v.5.0 View
Oral Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v.5.0 View
Pain SYSTEMATIC_ASSESSMENT General disorders CTCAE v.5.0 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE v.5.0 View
Papulopustular rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v.5.0 View
Paresthesia SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE v.5.0 View
Pericardial effusion SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE v.5.0 View
Periodontal disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v.5.0 View
Peripheral motor neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE v.5.0 View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE v.5.0 View
Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE v.5.0 View
Platelet Count Decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE v.5.0 View
Pleural Effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v.5.0 View
Pleuritic pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v.5.0 View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE v.5.0 View
Proctitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v.5.0 View
Productive cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v.5.0 View
Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE v.5.0 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v.5.0 View
Pulmonary edema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v.5.0 View
Pulmonary hypertension SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v.5.0 View
Purpura SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v.5.0 View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v.5.0 View
Rectal Hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v.5.0 View
Rectal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v.5.0 View
Resp, thoracic & mediast - Other - Hemoptysis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v.5.0 View
Resp, thoracic & mediast - Other - Nasal dryness SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v.5.0 View
Resp, thoracic & mediast - Other - Nasal irritation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v.5.0 View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v.5.0 View
Restlessness SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE v.5.0 View
Retinal Tear SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v.5.0 View
Rhinorrhea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v.5.0 View
Scrotal pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAE v.5.0 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE v.5.0 View
Sinus bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE v.5.0 View
Sinus tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE v.5.0 View
Skin & subcutaneous tissue -Other - Actinic Keratosis Reaction SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v.5.0 View
Skin & subcutaneous tissue -Other - Back Lesion SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v.5.0 View
Skin & subcutaneous tissue -Other - Erythema around line insertion SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v.5.0 View
Skin & subcutaneous tissue -Other - L Ankle lesion SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v.5.0 View
Skin & subcutaneous tissue -Other - L skin lesion (Wrist) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v.5.0 View
Skin & subcutaneous tissue -Other - Petechial rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v.5.0 View
Skin & subcutaneous tissue -Other - Purulence at site of prior picc line SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v.5.0 View
Skin & subcutaneous tissue -Other - R leg nodules SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v.5.0 View
Skin & subcutaneous tissue -Other - R leg subcu nodules SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v.5.0 View
Skin & subcutaneous tissue -Other - Right neck rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v.5.0 View
Skin & subcutaneous tissue -Other - nodule SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v.5.0 View
Skin infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE v.5.0 View
Soft tissue infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE v.5.0 View
Sore Throat SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v.5.0 View
Supraventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE v.5.0 View
Thromboembolic event SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE v.5.0 View
Thrush SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE v.5.0 View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE v.5.0 View
Typhlitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v.5.0 View
Upper gastrointestinal hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v.5.0 View
Upper respiratory infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE v.5.0 View
Urinary frequency SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE v.5.0 View
Urinary incontinence SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE v.5.0 View
Urinary retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE v.5.0 View
Urinary urgency SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE v.5.0 View
Vaginal hemorrhage SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAE v.5.0 View
Vaginal pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAE v.5.0 View
Vascular access complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE v.5.0 View
Ventricular arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE v.5.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v.5.0 View
Weight gain SYSTEMATIC_ASSESSMENT Investigations CTCAE v.5.0 View
Weight loss SYSTEMATIC_ASSESSMENT Investigations CTCAE v.5.0 View
Wheezing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v.5.0 View
White blood cell decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE v.5.0 View