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 @ 3:16 PM
Ignite Modification Date:
2025-12-25 @ 1:38 PM
NCT ID:
NCT02303392
Description:
CTCAE version 4.0 is used to grade all adverse events and to provide management guidelines for administrational toxicity. Adverse events from all arms are reported together as participants on all arms received the same treatment regimen.
Frequency Threshold:
5
Time Frame:
All patients must be carefully monitored for AEs, including clinical laboratory tests. AEs should be assessed in terms of their seriousness, intensity, and relationship to the study drug. For consistency, events are to be graded using the CTCAE version 4.0 from start of study to completion for up to 4 years.
Study:
NCT02303392
Study Brief:
Selinexor and Ibrutinib in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Aggressive Non-Hodgkin Lymphoma
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Chronic Lymphocytic Leukemia (CLL) | Patients receive ibrutinib PO on days 8-28 of course 1 and on days 1-28 on subsequent courses and selinexor PO BID weekly on day 1 or bi-weekly on days 1 and 3. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Selinexor: Given PO Ibrutinib: Given PO Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies | 1 | None | 6 | 16 | 16 | 16 | View |
| Non-Hodgkin Lymphoma (NHL) | Patients receive ibrutinib PO on days 8-28 of course 1 and on days 1-28 on subsequent courses and selinexor PO BID weekly on day 1 or bi-weekly on days 1 and 3. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Selinexor: Given PO Ibrutinib: Given PO Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies | 4 | None | 7 | 18 | 18 | 18 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Colonic Obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v4.0 | View |
| Lung Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE v4.0 | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE v4.0 | View |
| Death, NOS | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE v4.0 | View |
| Hypercalcemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v4.0 | View |
| Anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE v4.0 | View |
| Confusion | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE v4.0 | View |
| Encephalopathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE v4.0 | View |
| Febrile Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE v4.0 | View |
| Infections and Infestations-other | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE v4.0 | View |
| Platelet Count Decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v4.0 | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE v4.0 | View |
| Multi-organ Failure | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE v4.0 | View |
| Respiratory Failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | View |
| Upper Respiratory Infection | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | View |
| Back Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | View |
| Palpitations | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE v4.0 | View |
| Pancreatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v4.0 | View |
| Renal Calculi | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE v4.0 | View |
| Blood and lymphatic system disorders, Other | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE v4.0 | View |
| E. coli bacteremia | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE v4.0 | View |
| Hypoxia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | View |
| Pneumonitis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | View |
| Acute Kidney Injury | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE v4.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v4.0 | View |
| Actinic Keratosis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE v4.0 | View |
| Allergic rhinitis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v4.0 | View |
| Altered Mental Status | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE v4.0 | View |
| Anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE v4.0 | View |
| Anorexia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v4.0 | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE v4.0 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | View |
| Arthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v4.0 | View |
| Asthma | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | View |
| Atelectasis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | View |
| Atrial Flutter | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE v4.0 | View |
| Atrial Fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE v4.0 | View |
| Autoimmune disorder (Sjogren's syndrome) | SYSTEMATIC_ASSESSMENT | Immune system disorders | CTCAE v4.0 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | View |
| Basal Cell Carcinoma | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE v4.0 | View |
| Benign Polyp | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE v4.0 | View |
| Benign Prostatic Hypertrophy (BPH) | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | CTCAE v4.0 | View |
| Blood Blisters | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE v4.0 | View |
| Blurry Vision | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE v4.0 | View |
| Bone spur | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | View |
| Bowel Obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v4.0 | View |
| Bradycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE v4.0 | View |
| Brain fog | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE v4.0 | View |
| Brittle nails | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE v4.0 | View |
| Bronchial infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE v4.0 | View |
| Bruising | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE v4.0 | View |
| Bruxism | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v4.0 | View |
| Cardiac disorder - other Chest Pressure, intermittent | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE v4.0 | View |
| Cataract | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE v4.0 | View |
| Cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE v4.0 | View |
| Chest heaviness | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | View |
| Chest Tightness | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE v4.0 | View |
| Chest wall pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | View |
| Chills (Intermittent) | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE v4.0 | View |
| Chronic Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE v4.0 | View |
| Chylothorax | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | View |
| Dyspnea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | View |
| Early satiety | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v4.0 | View |
| Edema | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE v4.0 | View |
| Enlarged Left Lingual Tonsil | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE v4.0 | View |
| Enterocolitis infectious | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE v4.0 | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | View |
| Erectile Dysfunction | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | CTCAE v4.0 | View |
| Eustachian Tube Dysfunction | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | CTCAE v4.0 | View |
| Eye disorders, other - itching, without redness, swelling, or watering | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE v4.0 | View |
| Eye Infection | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE v4.0 | View |
| Eye pain | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE v4.0 | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE v4.0 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE v4.0 | View |
| Fever | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE v4.0 | View |
| Flank pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | View |
| Flu Like Symptoms | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE v4.0 | View |
| Folliculitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE v4.0 | View |
| Gastroesophageal Reflux Disease (GERD) | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v4.0 | View |
| Generalized Muscle Weakness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | View |
| Loose stool | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v4.0 | View |
| Clay colored stool | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v4.0 | View |
| Ground Glass Opacities | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE v4.0 | View |
| Hearing impaired | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | CTCAE v4.0 | View |
| Hematuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE v4.0 | View |
| Herpes Zoster | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE v4.0 | View |
| Hot flashes | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE v4.0 | View |
| Hypercalcemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v4.0 | View |
| Hypercholesterolemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v4.0 | View |
| Hyperglycemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v4.0 | View |
| Hyperhidrosis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE v4.0 | View |
| Hyperkalemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v4.0 | View |
| Hypermagnesemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v4.0 | View |
| Hypernatremia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v4.0 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE v4.0 | View |
| Hyperuricemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v4.0 | View |
| Hypoalbuminemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v4.0 | View |
| Hypocalcemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v4.0 | View |
| Hypogonadism | SYSTEMATIC_ASSESSMENT | Endocrine disorders | CTCAE v4.0 | View |
| Hypokalemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v4.0 | View |
| Hypomagnesemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v4.0 | View |
| Hyponatremia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v4.0 | View |
| Hypophosphatemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v4.0 | View |
| Hypoproteinemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v4.0 | View |
| Hypothyroidism | SYSTEMATIC_ASSESSMENT | Endocrine disorders | CTCAE v4.0 | View |
| Increased BNP | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE v4.0 | View |
| Malaise | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE v4.0 | View |
| Ingrown toenail | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE v4.0 | View |
| International normalized ratio (INR) increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v4.0 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE v4.0 | View |
| Muscle cramp | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | View |
| Non-cardiac chest pain | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE v4.0 | View |
| Intermittent Postnasal Drip | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | View |
| Renal calculi | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE v4.0 | View |
| Vaginal hemorrhage | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | CTCAE v4.0 | View |
| Iron deficiency | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE v4.0 | View |
| Knee injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE v4.0 | View |
| Knee sprain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE v4.0 | View |
| Lactate Dehydrogenase (LDH) increased | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE v4.0 | View |
| Lesion | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE v4.0 | View |
| Left index finger knuckle purple discoloration with a scab, secondary to trauma | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE v4.0 | View |
| Leukocytosis | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE v4.0 | View |
| Localized edema | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE v4.0 | View |
| Low Vitamin D | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v4.0 | View |
| Lower Lip Lesion | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v4.0 | View |
| Lung Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE v4.0 | View |
| Lymph node pain | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE v4.0 | View |
| Lymphocyte count increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v4.0 | View |
| Lymphocyte count decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v4.0 | View |
| Menorrhagia | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | CTCAE v4.0 | View |
| Mucositis Oral | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v4.0 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | View |
| Nail splitting | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE v4.0 | View |
| Nasal congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v4.0 | View |
| Neck Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | View |
| Neutrophil count decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v4.0 | View |
| Urinary urgency | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE v4.0 | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | View |
| Bone pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE v4.0 | View |
| Palpitations | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE v4.0 | View |
| Paresthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE v4.0 | View |
| Petechiae | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE v4.0 | View |
| Platelet count decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v4.0 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE v4.0 | View |
| Pneumonitis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | View |
| Pneumothorax | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | View |
| Presyncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE v4.0 | View |
| Prostate Cancer | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | CTCAE v4.0 | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE v4.0 | View |
| Pulmonary Embolism | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE v4.0 | View |
| Pulsatile Tinnitus | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | CTCAE v4.0 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE v4.0 | View |
| Rhinorrhea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | View |
| Right small finger knuckle purple discoloration with a scab, secondary to trauma | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE v4.0 | View |
| Shin cramps | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | View |
| Sinus Disorder | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | View |
| Sinus Pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | View |
| Sinus Tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE v4.0 | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE v4.0 | View |
| Bug bite hypersensitivity | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE v4.0 | View |
| Skin ulceration | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE v4.0 | View |
| Sore throat | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | View |
| Squamous cell carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE v4.0 | View |
| Stomach Pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v4.0 | View |
| Subconjunctival Hemorrhage | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE v4.0 | View |
| Superficial Venous Thrombus (Left Radial Vein) | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE v4.0 | View |
| Tinnitus | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | CTCAE v4.0 | View |
| Upper Respiratory Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE v4.0 | View |
| Urinary frequency | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE v4.0 | View |
| Urinary incontinence | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE v4.0 | View |
| Urinary retention | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE v4.0 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE v4.0 | View |
| Urinary tract pain | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE v4.0 | View |
| Visual aura | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE v4.0 | View |
| Vitreous hemorrhage | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE v4.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v4.0 | View |
| Watering eyes | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE v4.0 | View |
| Wheezing | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | View |
| White blood cell count decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v4.0 | View |
| Allergic Reaction | SYSTEMATIC_ASSESSMENT | Immune system disorders | CTCAE v4.0 | View |
| Anterior uveitis | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE v4.0 | View |
| Ascites | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v4.0 | View |
| Barrett's Esophagus | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v4.0 | View |
| Benign prostatic hyperplasia | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | CTCAE v4.0 | View |
| Blood bilirubin increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v4.0 | View |
| C. difficile infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE v4.0 | View |
| Chronic back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | View |
| Chronic Sciatic Nerve Pain | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE v4.0 | View |
| Colon Polyps | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE v4.0 | View |
| Colon Resection | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v4.0 | View |
| Intermittent Cramps | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | View |
| Coronary artery disease | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE v4.0 | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v4.0 | View |
| Diverticulitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v4.0 | View |
| DLBCL (richter's transformation) | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE v4.0 | View |
| Dyslipidemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v4.0 | View |
| Dysphagia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v4.0 | View |
| Electrocardiogram QT corrected interval prolonged | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v4.0 | View |
| Eye disorder - other, decreased visual acuity right eye | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE v4.0 | View |
| Facial nerve disorder (cranial nerve VII dysfunction) | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE v4.0 | View |
| Flatulence | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v4.0 | View |
| Floaters | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE v4.0 | View |
| Fluid build up in ears | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | CTCAE v4.0 | View |
| Glaucoma | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE v4.0 | View |
| Hepatitis C | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE v4.0 | View |
| Hyperlipidemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v4.0 | View |
| Hypogammaglobulinemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE v4.0 | View |
| Hypoxia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE v4.0 | View |
| Hemorrhoids | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v4.0 | View |
| Ischemic cardiomyopathy | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE v4.0 | View |
| Laceration | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE v4.0 | View |
| Lymphedema | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE v4.0 | View |
| Macular degeneration | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE v4.0 | View |
| Macular Pucker | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE v4.0 | View |
| Memory impairment | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE v4.0 | View |
| MSSA Bacteremia | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE v4.0 | View |
| Muscle weakness in lower limb | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | View |
| Myocarditis | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE v4.0 | View |
| Neck injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE v4.0 | View |
| Neuralgia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE v4.0 | View |
| Osteoporosis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | View |
| palpable lymph node | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE v4.0 | View |
| Peripheral motor neuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE v4.0 | View |
| Photophobia | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE v4.0 | View |
| Productive Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | View |
| Prothrombin time prolonged | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE v4.0 | View |
| Pyelonephritis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE v4.0 | View |
| Red spots on arm | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE v4.0 | View |
| Renal disorder, other | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE v4.0 | View |
| Tachypnea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | View |
| Restlessness | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE v4.0 | View |
| Right Eye Swelling | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE v4.0 | View |
| Right vision changes | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE v4.0 | View |
| Septic Shock | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE v4.0 | View |
| Skin graft (leg to arm & chest) | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | CTCAE v4.0 | View |
| Intermittent skin discoloration | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE v4.0 | View |
| Sleep apnea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | View |
| Sneezing | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | View |
| Somnolence | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE v4.0 | View |
| Spinal fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE v4.0 | View |
| Split Fingertips and Toes | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE v4.0 | View |
| Sudden onset of slurred speech and difficulty with word forming (intermittent) | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE v4.0 | View |
| Intermittent Sweats | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE v4.0 | View |
| Thrush in the mouth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v4.0 | View |
| Total Knee Arthroplasty (Right) | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | CTCAE v4.0 | View |
| Transient ischemic attack | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE v4.0 | View |
| Tubular Adenoma of the Colon | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v4.0 | View |
| Urinary tract obstruction - with bilateral hydronephrosis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE v4.0 | View |
| Vascular Disorder, Other - diffuse Petechia | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE v4.0 | View |
| Vitamin D Deficiency | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v4.0 | View |
| Otitis media | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE v4.0 | View |
| Alkaline Phosphatase increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v4.0 | View |
| Cold | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE v4.0 | View |
| Cold sore | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE v4.0 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v4.0 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | View |
| Creatinine Increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v4.0 | View |
| Deep Vein Thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE v4.0 | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE v4.0 | View |
| Diabetes Mellitus | SYSTEMATIC_ASSESSMENT | Endocrine disorders | CTCAE v4.0 | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v4.0 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE v4.0 | View |
| Dry cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | View |
| Dry eye | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE v4.0 | View |
| Dry mouth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v4.0 | View |
| Dry skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE v4.0 | View |
| Dysgeusia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE v4.0 | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v4.0 | View |
| Fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE v4.0 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE v4.0 | View |
| Intermittent Ocular Migraine | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE v4.0 | View |
| Intermittent Oral Sores | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE v4.0 | View |
| Peripheral sensory neuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE v4.0 | View |
| Oral Pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v4.0 | View |
| Pleural effusion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | View |
| Pleuritic pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | View |
| Restless Leg Symptoms | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE v4.0 | View |
| Skin Infection | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE v4.0 | View |
| Skin splitting on fingertips | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE v4.0 | View |
| Weight gain | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v4.0 | View |
| Weight loss | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v4.0 | View |
| Bullous Dermatitis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE v4.0 | View |
| Tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE v4.0 | View |
| Gastritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v4.0 | View |
| Lip blister | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v4.0 | View |
| Obesity | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v4.0 | View |
| Activated partial thromboplastin time prolonged | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v4.0 | View |