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 @ 11:51 PM
Ignite Modification Date:
2025-12-25 @ 9:45 PM
NCT ID:
NCT02560051
Description:
None
Frequency Threshold:
0
Time Frame:
From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 10 months.
Study:
NCT02560051
Study Brief:
Hormone Therapy Plus Chemotherapy as Initial Treatment for Local Failures or Advanced Prostate Cancer
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Definitive Local Therapy | 3 cycles of chemotherapy (doxorubicin, ketoconazole, docetaxel and estramustine) + 12 months ADT (degarelix) Doxorubicin: In weeks 1, 3, and 5 of each 8-week cycle, participants will receive doxorubicin (20 mg/m2 as a 24-hour intravenous infusion on day 1 of each applicable week) Ketoconazole: In weeks 1, 3, and 5 of each 8-week cycle, participants will receive ketoconazole (400 mg orally 3 times daily for 7 days) Docetaxel: In weeks 2, 4, and 6 of each 8-week cycle, participants will receive docetaxel (35 mg/m2 intravenously on day 1 of each applicable week) Estramustine: In weeks 2, 4, and 6 of each 8-week cycle, participants will receive estramustine (280 mg orally 3 times daily for 7 days) Degarelix: The starting dose (240 mg given as two injections of 120 mg each) is followed by maintenance doses of 80 mg administered as a single injection every 28 days | 0 | None | 3 | 6 | 6 | 6 | View |
| Nodal Only/Low-volume Bone | 4 cycles of chemotherapy (doxorubicin, ketoconazole, docetaxel and estramustine) + 18 months ADT (degarelix) Doxorubicin: In weeks 1, 3, and 5 of each 8-week cycle, participants will receive doxorubicin (20 mg/m2 as a 24-hour intravenous infusion on day 1 of each applicable week) Ketoconazole: In weeks 1, 3, and 5 of each 8-week cycle, participants will receive ketoconazole (400 mg orally 3 times daily for 7 days) Docetaxel: In weeks 2, 4, and 6 of each 8-week cycle, participants will receive docetaxel (35 mg/m2 intravenously on day 1 of each applicable week) Estramustine: In weeks 2, 4, and 6 of each 8-week cycle, participants will receive estramustine (280 mg orally 3 times daily for 7 days) Degarelix: The starting dose (240 mg given as two injections of 120 mg each) is followed by maintenance doses of 80 mg administered as a single injection every 28 days | 0 | None | 2 | 8 | 8 | 8 | View |
| High Volume/no Prior tx | 5 cycles of chemotherapy (doxorubicin, ketoconazole, docetaxel and estramustine) + 24 months ADT (degarelix) Doxorubicin: In weeks 1, 3, and 5 of each 8-week cycle, participants will receive doxorubicin (20 mg/m2 as a 24-hour intravenous infusion on day 1 of each applicable week) Ketoconazole: In weeks 1, 3, and 5 of each 8-week cycle, participants will receive ketoconazole (400 mg orally 3 times daily for 7 days) Docetaxel: In weeks 2, 4, and 6 of each 8-week cycle, participants will receive docetaxel (35 mg/m2 intravenously on day 1 of each applicable week) Estramustine: In weeks 2, 4, and 6 of each 8-week cycle, participants will receive estramustine (280 mg orally 3 times daily for 7 days) Degarelix: The starting dose (240 mg given as two injections of 120 mg each) is followed by maintenance doses of 80 mg administered as a single injection every 28 days | 0 | None | 0 | 5 | 5 | 5 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | NCI CTCAE Versio 4.0 | View |
| Sinus Tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | NCI CTCAE Versio 4.0 | View |
| Abdominal Pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI CTCAE Versio 4.0 | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI CTCAE Versio 4.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI CTCAE Versio 4.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI CTCAE Versio 4.0 | View |
| Fever | SYSTEMATIC_ASSESSMENT | General disorders | NCI CTCAE Versio 4.0 | View |
| Chills | SYSTEMATIC_ASSESSMENT | General disorders | NCI CTCAE Versio 4.0 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | NCI CTCAE Versio 4.0 | View |
| Urinary Tract Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | NCI CTCAE Versio 4.0 | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | NCI CTCAE Versio 4.0 | View |
| Creatinine Increased | SYSTEMATIC_ASSESSMENT | Investigations | NCI CTCAE Versio 4.0 | View |
| White blood cell decreased | SYSTEMATIC_ASSESSMENT | Investigations | NCI CTCAE Versio 4.0 | View |
| Hypokalemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | NCI CTCAE Versio 4.0 | View |
| Hypoalbuminemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | NCI CTCAE Versio 4.0 | View |
| Anorexia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | NCI CTCAE Versio 4.0 | View |
| Hypophosphatemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | NCI CTCAE Versio 4.0 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | NCI CTCAE Versio 4.0 | View |
| Post nasal drip | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | NCI CTCAE Versio 4.0 | View |
| Dyspnea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | NCI CTCAE Versio 4.0 | View |
| Hypoxia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | NCI CTCAE Versio 4.0 | View |
| Respiratory, thoracic and mediastinal disorders, Pulmonary inflammation | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | NCI CTCAE Versio 4.0 | View |
| Thromboembolic event | SYSTEMATIC_ASSESSMENT | Vascular disorders | NCI CTCAE Versio 4.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Atrial flutter | SYSTEMATIC_ASSESSMENT | Cardiac disorders | NCI CTCAE Versio 4.0 | View |
| Cardiac disorders, Inverted T-wave on EKG | SYSTEMATIC_ASSESSMENT | Cardiac disorders | NCI CTCAE Versio 4.0 | View |
| Chest pain - cardiac | SYSTEMATIC_ASSESSMENT | Cardiac disorders | NCI CTCAE Versio 4.0 | View |
| Myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | NCI CTCAE Versio 4.0 | View |
| Sinus tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | NCI CTCAE Versio 4.0 | View |
| Blurred Vision | SYSTEMATIC_ASSESSMENT | Eye disorders | NCI CTCAE Versio 4.0 | View |
| Dry Eye | SYSTEMATIC_ASSESSMENT | Eye disorders | NCI CTCAE Versio 4.0 | View |
| Eye disorders, Red eyes | SYSTEMATIC_ASSESSMENT | Eye disorders | NCI CTCAE Versio 4.0 | View |
| Watering eyes | SYSTEMATIC_ASSESSMENT | Eye disorders | NCI CTCAE Versio 4.0 | View |
| Abdominal distension | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI CTCAE Versio 4.0 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI CTCAE Versio 4.0 | View |
| Bloating | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI CTCAE Versio 4.0 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI CTCAE Versio 4.0 | View |
| Dental caries | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI CTCAE Versio 4.0 | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI CTCAE Versio 4.0 | View |
| Gastrointestinal Disorders, Loose stools | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI CTCAE Versio 4.0 | View |
| Hemorrhoids | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI CTCAE Versio 4.0 | View |
| Mucositis Oral | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI CTCAE Versio 4.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI CTCAE Versio 4.0 | View |
| Oral Pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI CTCAE Versio 4.0 | View |
| Stomach Pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI CTCAE Versio 4.0 | View |
| Vomitting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI CTCAE Versio 4.0 | View |
| Chills | SYSTEMATIC_ASSESSMENT | General disorders | NCI CTCAE Versio 4.0 | View |
| Edema face | SYSTEMATIC_ASSESSMENT | General disorders | NCI CTCAE Versio 4.0 | View |
| Edema limbs | SYSTEMATIC_ASSESSMENT | General disorders | NCI CTCAE Versio 4.0 | View |
| Edema trunk | SYSTEMATIC_ASSESSMENT | General disorders | NCI CTCAE Versio 4.0 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | NCI CTCAE Versio 4.0 | View |
| Fever | SYSTEMATIC_ASSESSMENT | General disorders | NCI CTCAE Versio 4.0 | View |
| Flu like symptoms | SYSTEMATIC_ASSESSMENT | General disorders | NCI CTCAE Versio 4.0 | View |
| General disorders and administration site conditions, Foot irritation/infection | SYSTEMATIC_ASSESSMENT | General disorders | NCI CTCAE Versio 4.0 | View |
| Infusion related reaction | SYSTEMATIC_ASSESSMENT | General disorders | NCI CTCAE Versio 4.0 | View |
| Injection Site Reaction | SYSTEMATIC_ASSESSMENT | General disorders | NCI CTCAE Versio 4.0 | View |
| Malaise | SYSTEMATIC_ASSESSMENT | General disorders | NCI CTCAE Versio 4.0 | View |
| Non-cardiac chest pain | SYSTEMATIC_ASSESSMENT | General disorders | NCI CTCAE Versio 4.0 | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | NCI CTCAE Versio 4.0 | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | NCI CTCAE Versio 4.0 | View |
| Infections and Infestations, Thrush | SYSTEMATIC_ASSESSMENT | Infections and infestations | NCI CTCAE Versio 4.0 | View |
| Upper respiratory infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | NCI CTCAE Versio 4.0 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | NCI CTCAE Versio 4.0 | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | NCI CTCAE Versio 4.0 | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | NCI CTCAE Versio 4.0 | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | NCI CTCAE Versio 4.0 | View |
| Alkaline Phosphatase Increased | SYSTEMATIC_ASSESSMENT | Investigations | NCI CTCAE Versio 4.0 | View |
| Blood bilirubin increased | SYSTEMATIC_ASSESSMENT | Investigations | NCI CTCAE Versio 4.0 | View |
| Creatinine increased | SYSTEMATIC_ASSESSMENT | Investigations | NCI CTCAE Versio 4.0 | View |
| Neutrophil count decreased | SYSTEMATIC_ASSESSMENT | Investigations | NCI CTCAE Versio 4.0 | View |
| Platelet count decreased | SYSTEMATIC_ASSESSMENT | Investigations | NCI CTCAE Versio 4.0 | View |
| Weight gain | SYSTEMATIC_ASSESSMENT | Investigations | NCI CTCAE Versio 4.0 | View |
| Weight loss | SYSTEMATIC_ASSESSMENT | Investigations | NCI CTCAE Versio 4.0 | View |
| White blood cell decreased | SYSTEMATIC_ASSESSMENT | Investigations | NCI CTCAE Versio 4.0 | View |
| Hypoalbuminemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | NCI CTCAE Versio 4.0 | View |
| Hypocalcemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | NCI CTCAE Versio 4.0 | View |
| Hypokalemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | NCI CTCAE Versio 4.0 | View |
| Anorexia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | NCI CTCAE Versio 4.0 | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | NCI CTCAE Versio 4.0 | View |
| Hyperglycemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | NCI CTCAE Versio 4.0 | View |
| Hyperkalemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | NCI CTCAE Versio 4.0 | View |
| Metabolism and nutrition disorders, Hyperlipidemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | NCI CTCAE Versio 4.0 | View |
| Hypomagnesemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | NCI CTCAE Versio 4.0 | View |
| Hyponatremia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | NCI CTCAE Versio 4.0 | View |
| Hypophosphatemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | NCI CTCAE Versio 4.0 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | NCI CTCAE Versio 4.0 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | NCI CTCAE Versio 4.0 | View |
| Bone pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | NCI CTCAE Versio 4.0 | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | NCI CTCAE Versio 4.0 | View |
| Generalized muscle weakness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | NCI CTCAE Versio 4.0 | View |
| Concentration impairment | SYSTEMATIC_ASSESSMENT | Nervous system disorders | NCI CTCAE Versio 4.0 | View |
| Dysguesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | NCI CTCAE Versio 4.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | NCI CTCAE Versio 4.0 | View |
| Memory impairment | SYSTEMATIC_ASSESSMENT | Nervous system disorders | NCI CTCAE Versio 4.0 | View |
| Nervous system Disorders, Disease | SYSTEMATIC_ASSESSMENT | Nervous system disorders | NCI CTCAE Versio 4.0 | View |
| Paresthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | NCI CTCAE Versio 4.0 | View |
| Presyncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | NCI CTCAE Versio 4.0 | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | NCI CTCAE Versio 4.0 | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | NCI CTCAE Versio 4.0 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | NCI CTCAE Versio 4.0 | View |
| Renal and urinary disorders, Dysuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | NCI CTCAE Versio 4.0 | View |
| Hematuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | NCI CTCAE Versio 4.0 | View |
| Urinary frequency | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | NCI CTCAE Versio 4.0 | View |
| Urinary incontinence | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | NCI CTCAE Versio 4.0 | View |
| Urinary retention | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | NCI CTCAE Versio 4.0 | View |
| Urinary tract pain | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | NCI CTCAE Versio 4.0 | View |
| Urinary urgency | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | NCI CTCAE Versio 4.0 | View |
| Urine discoloration | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | NCI CTCAE Versio 4.0 | View |
| Breast pain | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | NCI CTCAE Versio 4.0 | View |
| Penile pain | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | NCI CTCAE Versio 4.0 | View |
| Prostatic pain | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | NCI CTCAE Versio 4.0 | View |
| Reproductive system and breast disorders, Penile irritation | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | NCI CTCAE Versio 4.0 | View |
| Allergic rhinitis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | NCI CTCAE Versio 4.0 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | NCI CTCAE Versio 4.0 | View |
| Dyspnea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | NCI CTCAE Versio 4.0 | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | NCI CTCAE Versio 4.0 | View |
| Hiccups | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | NCI CTCAE Versio 4.0 | View |
| Hypoxia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | NCI CTCAE Versio 4.0 | View |
| Nasal congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | NCI CTCAE Versio 4.0 | View |
| Pneumonitis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | NCI CTCAE Versio 4.0 | View |
| Postnasal drip | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | NCI CTCAE Versio 4.0 | View |
| Productive cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | NCI CTCAE Versio 4.0 | View |
| Respiratory, thoracic and mediastinal disorders, Nasal discharge | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | NCI CTCAE Versio 4.0 | View |
| Sore throat | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | NCI CTCAE Versio 4.0 | View |
| Alopecia | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | NCI CTCAE Versio 4.0 | View |
| Skin and subcutaneous tissue disorders, Skin irritation | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | NCI CTCAE Versio 4.0 | View |
| Nail discoloration | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | NCI CTCAE Versio 4.0 | View |
| Nail loss | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | NCI CTCAE Versio 4.0 | View |
| Rash acneiform | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | NCI CTCAE Versio 4.0 | View |
| Rash maculo-papular | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | NCI CTCAE Versio 4.0 | View |
| Skin induration | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | NCI CTCAE Versio 4.0 | View |
| Surgical and medical procedures, Soreness at site | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | NCI CTCAE Versio 4.0 | View |
| Flushing | SYSTEMATIC_ASSESSMENT | Vascular disorders | NCI CTCAE Versio 4.0 | View |
| Hot flashes | SYSTEMATIC_ASSESSMENT | Vascular disorders | NCI CTCAE Versio 4.0 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | NCI CTCAE Versio 4.0 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | NCI CTCAE Versio 4.0 | View |
| Thromboembolic event | SYSTEMATIC_ASSESSMENT | Vascular disorders | NCI CTCAE Versio 4.0 | View |
| Cardiac disorders, Atherosclerotic Ulcer in Posterior Arch of Aorta | SYSTEMATIC_ASSESSMENT | Cardiac disorders | NCI CTCAE Versio 4.0 | View |
| Eye disorders, Decreased vision | SYSTEMATIC_ASSESSMENT | Eye disorders | NCI CTCAE Versio 4.0 | View |
| Eye disorders, Discharge from eye | SYSTEMATIC_ASSESSMENT | Eye disorders | NCI CTCAE Versio 4.0 | View |
| Gastrointestinal disorders, tongue changes | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI CTCAE Versio 4.0 | View |
| Gastrointestinal disorders, Abdominal cramping | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI CTCAE Versio 4.0 | View |
| General disorders, Body aches/pain | SYSTEMATIC_ASSESSMENT | General disorders | NCI CTCAE Versio 4.0 | View |
| General disorders, Facial/Lip irritation | SYSTEMATIC_ASSESSMENT | General disorders | NCI CTCAE Versio 4.0 | View |
| General disorders, Mental Fogginess/Forgetfulness | SYSTEMATIC_ASSESSMENT | General disorders | NCI CTCAE Versio 4.0 | View |
| Renal and urinary disorders, Nocturia | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | NCI CTCAE Versio 4.0 | View |
| Renal and urinary disorders, Urinary burning | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | NCI CTCAE Versio 4.0 | View |
| Respiratory, thoracic and mediastinal disorders, Dry nostrils | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | NCI CTCAE Versio 4.0 | View |
| Skin and subcutaneous tissue disorders, Nail changes | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | NCI CTCAE Versio 4.0 | View |
| Skin and subcutaneous tissue disorders, Sweating | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | NCI CTCAE Versio 4.0 | View |
| Hoarseness | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | NCI CTCAE Versio 4.0 | View |
| Dry skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | NCI CTCAE Versio 4.0 | View |
| Gastrointestinal disorders, Motion sickness | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI CTCAE Versio 4.0 | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI CTCAE Versio 4.0 | View |
| Gastroesophageal Reflux | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI CTCAE Versio 4.0 | View |
| Irritability | SYSTEMATIC_ASSESSMENT | General disorders | NCI CTCAE Versio 4.0 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | NCI CTCAE Versio 4.0 | View |
| Psychiatric disorder, Emotional | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | NCI CTCAE Versio 4.0 | View |
| Anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | NCI CTCAE Versio 4.0 | View |
| Leukocytosis | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | NCI CTCAE Versio 4.0 | View |
| Dry mouth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI CTCAE Versio 4.0 | View |