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 |
|---|---|---|---|---|---|---|---|---|
| Pembrolizumab | Pembrolizumab: 200 mg Q3W, intravenous administration for a maximum of 2 years, or until progression or unacceptable toxicity. | 48 | None | 51 | 60 | 58 | 60 | View |
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Other - Death | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE 4.0 | View |
| Anorexia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE 4.0 | View |
| Fever | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE 4.0 | View |
| Lung infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE 4.0 | View |
| Confusion | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE 4.0 | View |
| Hypercalcemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE 4.0 | View |
| Hypoxia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE 4.0 | View |
| Pleural effusion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE 4.0 | View |
| Pneumonitis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE 4.0 | View |
| Stroke | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE 4.0 | View |
| Vestibular disorder | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | CTCAE 4.0 | View |
| Acute kidney injury | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE 4.0 | View |
| Adrenal insufficiency | SYSTEMATIC_ASSESSMENT | Endocrine disorders | CTCAE 4.0 | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE 4.0 | View |
| Ataxia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE 4.0 | View |
| Atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE 4.0 | View |
| Cardiac arrest | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE 4.0 | View |
| Other - Death | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE 4.0 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE 4.0 | View |
| Dysphasia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE 4.0 | View |
| Flank pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE 4.0 | View |
| Other - Hepatobiliary disorders | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | CTCAE 4.0 | View |
| Hypokalemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE 4.0 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE 4.0 | View |
| Other - Chest Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE 4.0 | View |
| Other - Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE 4.0 | View |
| Other - Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE 4.0 | View |
| Laryngeal hemorrhage | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE 4.0 | View |
| Mucositis oral | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE 4.0 | View |
| Other - Malignant neoplasm | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE 4.0 | View |
| Respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE 4.0 | View |
| Superior vena cava syndrome | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE 4.0 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE 4.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE 4.0 | View |
| Rash maculo-papular | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE 4.0 | View |
| Other - Haemoptysis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE 4.0 | View |
| Seizure | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE 4.0 | View |
| Other - Respiratory distress | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE 4.0 | View |
| None | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE 4.0 | View |
| Other - Shortness of Breath | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE 4.0 | View |
| Other - Shortness of Breath | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE 4.0 | View |
| Other - Lung infection | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE 4.0 | View |
| Other - Acute Kidney Injury | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE 4.0 | View |
| Other - Nervous System | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE 4.0 | View |
| Dyspnea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE 4.0 | View |
| Other - Death | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE 4.0 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE 4.0 | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE 4.0 | View |
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Other - Creatinine decreased | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE 4.0 | View |
| Other - Haemoptysis | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE 4.0 | View |
| Other - Hypercalcemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE 4.0 | View |
| Other - Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE 4.0 | View |
| Anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE 4.0 | View |
| Cardiac arrest | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE 4.0 | View |
| Other - Ejection systolic murmor | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE 4.0 | View |
| Heart failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE 4.0 | View |
| Myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE 4.0 | View |
| Palpitations | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE 4.0 | View |
| Sinus bradycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE 4.0 | View |
| Atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE 4.0 | View |
| Other - Hearing reduction | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | CTCAE 4.0 | View |
| Vestibular disorder | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | CTCAE 4.0 | View |
| Other - Adrenal insufficiency | SYSTEMATIC_ASSESSMENT | Endocrine disorders | CTCAE 4.0 | View |
| Hypophysitis | SYSTEMATIC_ASSESSMENT | Endocrine disorders | CTCAE 4.0 | View |
| Adrenal insufficiency | SYSTEMATIC_ASSESSMENT | Endocrine disorders | CTCAE 4.0 | View |
| Hyperthyroidism | SYSTEMATIC_ASSESSMENT | Endocrine disorders | CTCAE 4.0 | View |
| Hypothyroidism | SYSTEMATIC_ASSESSMENT | Endocrine disorders | CTCAE 4.0 | View |
| Other - Age related reduced visual acuity | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE 4.0 | View |
| Other - Thromboembolic event left eye | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE 4.0 | View |
| Watering eyes | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE 4.0 | View |
| Colitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE 4.0 | View |
| Dry mouth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE 4.0 | View |
| Other - Altered taste | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE 4.0 | View |
| Other - Decreased appetite | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE 4.0 | View |
| Other - Gastric reflux | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE 4.0 | View |
| Other - Reflux | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE 4.0 | View |
| Mucositis oral | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE 4.0 | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE 4.0 | View |
| Dysphagia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE 4.0 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE 4.0 | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE 4.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE 4.0 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE 4.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE 4.0 | View |
| Chills | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE 4.0 | View |
| Flu like symptoms | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE 4.0 | View |
| Other - Abdominal pain | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE 4.0 | View |
| Other - Chest wall discomfort (occasional) | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE 4.0 | View |
| Other - Cough | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE 4.0 | View |
| Other - Dehydration | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE 4.0 | View |
| Other - Edema feet | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE 4.0 | View |
| Other - Hair thinning | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE 4.0 | View |
| Other - Head cold | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE 4.0 | View |
| Other - Itch | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE 4.0 | View |
| Other - Leg cramps | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE 4.0 | View |
| Other - Poor appetite | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE 4.0 | View |
| Other - Raised sputum viscosity | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE 4.0 | View |
| Other - Sore throat | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE 4.0 | View |
| Other - Swollen feet and ankles | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE 4.0 | View |
| Other - Weight loss | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE 4.0 | View |
| Infusion related reaction | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE 4.0 | View |
| Non-cardiac chest pain | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE 4.0 | View |
| Malaise | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE 4.0 | View |
| Edema limbs | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE 4.0 | View |
| Fever | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE 4.0 | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE 4.0 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE 4.0 | View |
| Other - Bilirubin increased | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | CTCAE 4.0 | View |
| Other - Drug induced liver injury | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | CTCAE 4.0 | View |
| Other - Raised alk phosphate | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | CTCAE 4.0 | View |
| Other - Rash | SYSTEMATIC_ASSESSMENT | Immune system disorders | CTCAE 4.0 | View |
| Bronchial infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE 4.0 | View |
| Other - Chest infections | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE 4.0 | View |
| Other - Chest Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE 4.0 | View |
| Other - Cystitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE 4.0 | View |
| Other - Genital candida | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE 4.0 | View |
| Other - Infected picc line | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE 4.0 | View |
| Other - Lower respiratory track infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE 4.0 | View |
| Other - Lower respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE 4.0 | View |
| Other - Oral candida | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE 4.0 | View |
| Other - Oral candidiasis | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE 4.0 | View |
| Other - Picc line infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE 4.0 | View |
| Other - Presumed uti | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE 4.0 | View |
| Other - Thrush | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE 4.0 | View |
| Other - Undefined infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE 4.0 | View |
| Other - Unwell | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE 4.0 | View |
| Other - Viral infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE 4.0 | View |
| Other - Viral infection around mouth | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE 4.0 | View |
| Papulopustular rash | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE 4.0 | View |
| Other - Oral thrush | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE 4.0 | View |
| Skin infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE 4.0 | View |
| Other - Chest infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE 4.0 | View |
| Upper respiratory infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE 4.0 | View |
| Lung infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE 4.0 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE 4.0 | View |
| Bruising | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE 4.0 | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE 4.0 | View |
| Activated partial thromboplastin time prolonged | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE 4.0 | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE 4.0 | View |
| Blood bilirubin increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE 4.0 | View |
| Blood corticotrophin decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE 4.0 | View |
| GGT increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE 4.0 | View |
| Other - Cortisol low | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE 4.0 | View |
| Other - Hyperbilirubinemia | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE 4.0 | View |
| Other - Ldh raised - 794 (uln 480) | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE 4.0 | View |
| Other - Thyroid stimulating hormone increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE 4.0 | View |
| Lymphocyte count decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE 4.0 | View |
| Serum amylase increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE 4.0 | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE 4.0 | View |
| Creatinine increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE 4.0 | View |
| Weight loss | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE 4.0 | View |
| Hypercalcemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE 4.0 | View |
| Hypoalbuminemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE 4.0 | View |
| Hypocalcemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE 4.0 | View |
| Other - Low b12 | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE 4.0 | View |
| Obesity | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE 4.0 | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE 4.0 | View |
| Hyperglycemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE 4.0 | View |
| Hypokalemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE 4.0 | View |
| Hypomagnesemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE 4.0 | View |
| Hyponatremia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE 4.0 | View |
| Anorexia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE 4.0 | View |
| Muscle weakness left-sided | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE 4.0 | View |
| Muscle weakness lower limb | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE 4.0 | View |
| Muscle weakness upper limb | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE 4.0 | View |
| Other - Bruising to left arm (garden gate hit it) | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE 4.0 | View |
| Other - Discitis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE 4.0 | View |
| Other - Generalised muscle weakness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE 4.0 | View |
| Other - Generalized muscle weakness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE 4.0 | View |
| Other - Heavy and painful left calf | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE 4.0 | View |
| Other - Joint pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE 4.0 | View |
| Other - Left arm pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE 4.0 | View |
| Other - Left hip/ pelvic pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE 4.0 | View |
| Other - Left sided gluteal pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE 4.0 | View |
| Other - Leg ache | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE 4.0 | View |
| Other - Muscle pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE 4.0 | View |
| Other - Muscle spasms | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE 4.0 | View |
| Other - Right hand weakness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE 4.0 | View |
| Osteoporosis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE 4.0 | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE 4.0 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE 4.0 | View |
| Flank pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE 4.0 | View |
| Other - Knee pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE 4.0 | View |
| Other - Left shoulder pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE 4.0 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE 4.0 | View |
| Neck pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE 4.0 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE 4.0 | View |
| Other - Death | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE 4.0 | View |
| Ataxia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE 4.0 | View |
| Concentration impairment | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE 4.0 | View |
| Dysphasia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE 4.0 | View |
| Memory impairment | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE 4.0 | View |
| Other - Involuntary neck movements | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE 4.0 | View |
| Other - Pins & needles in right arm during antibiotic infusion | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE 4.0 | View |
| Other - Tingling in extremeties | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE 4.0 | View |
| Nystagmus | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE 4.0 | View |
| Seizure | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE 4.0 | View |
| Stroke | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE 4.0 | View |
| Tremor | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE 4.0 | View |
| Lethargy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE 4.0 | View |
| Paresthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE 4.0 | View |
| Peripheral sensory neuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE 4.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE 4.0 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE 4.0 | View |
| Confusion | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE 4.0 | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE 4.0 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE 4.0 | View |
| Cystitis noninfective | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE 4.0 | View |
| Proteinuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE 4.0 | View |
| Other - Raised creatinine | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE 4.0 | View |
| Other - Renal failure | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE 4.0 | View |
| Other - Urinary infection | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE 4.0 | View |
| Other - Worsening of renal function | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE 4.0 | View |
| Urinary frequency | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE 4.0 | View |
| Chronic kidney disease | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE 4.0 | View |
| Acute kidney injury | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE 4.0 | View |
| Bronchopulmonary hemorrhage | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE 4.0 | View |
| Hoarseness | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE 4.0 | View |
| Laryngeal hemorrhage | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE 4.0 | View |
| Pleuritic pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE 4.0 | View |
| Pneumonitis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE 4.0 | View |
| Pulmonary edema | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE 4.0 | View |
| Other - Bronchitis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE 4.0 | View |
| Other - Cap-community acquired pneumonia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE 4.0 | View |
| Other - Chest pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE 4.0 | View |
| Other - Exacerbation of copd | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE 4.0 | View |
| Other - Increased sputum-brown | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE 4.0 | View |
| Other - Lower respiratory track infection | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE 4.0 | View |
| Other - Lower respiratory tract infection | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE 4.0 | View |
| Other - Lung crackles | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE 4.0 | View |
| Other - Mucositis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE 4.0 | View |
| Other - Reduced air entry and a few creps | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE 4.0 | View |
| Other - Reduced air entry to right lung | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE 4.0 | View |
| Other - Reduced air entry to the right lower lobe | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE 4.0 | View |
| Other - Reduced breath sounds left upper lobe | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE 4.0 | View |
| Other - Respiratory distress | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE 4.0 | View |
| Other - Respiratory infection | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE 4.0 | View |
| Other - Right basal chest infection | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE 4.0 | View |
| Other - Scattered creps | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE 4.0 | View |
| Other - Shortness of breath | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE 4.0 | View |
| Other - Shortness of breath on minimal exertion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE 4.0 | View |
| Other - White phlegm | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE 4.0 | View |
| Sore throat | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE 4.0 | View |
| Other - Chest infection | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE 4.0 | View |
| Productive cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE 4.0 | View |
| Other - Exacerbation of chronic obstructive pulmonary disease | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE 4.0 | View |
| Other - Pneumonia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE 4.0 | View |
| Pleural effusion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE 4.0 | View |
| Other - Haemoptysis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE 4.0 | View |
| Hypoxia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE 4.0 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE 4.0 | View |
| Dyspnea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE 4.0 | View |
| Other - Abdominal rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE 4.0 | View |
| Other - Blisters on hands | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE 4.0 | View |
| Other - Dry skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE 4.0 | View |
| Other - Dry skin on legs | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE 4.0 | View |
| Other - Dry skin under right eye | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE 4.0 | View |
| Other - Fungal skin rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE 4.0 | View |
| Other - Infected sebaceous cycst | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE 4.0 | View |
| Other - Itch | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE 4.0 | View |
| Other - Itch skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE 4.0 | View |
| Other - Itching | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE 4.0 | View |
| Other - Itchy face | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE 4.0 | View |
| Other - Itchy skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE 4.0 | View |
| Other - Papulopustular | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE 4.0 | View |
| Other - Pitting oedema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE 4.0 | View |
| Other - Pressure ulcer | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE 4.0 | View |
| Other - Psoriasis rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE 4.0 | View |
| Other - Rash on legs | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE 4.0 | View |
| Other - Rash on the legs and arms | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE 4.0 | View |
| Other - Red legs and mild oedema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE 4.0 | View |
| Other - Skin lesion to scalp | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE 4.0 | View |
| Other - Sore feet and toes | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE 4.0 | View |
| Other - Sore naval | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE 4.0 | View |
| Other - Ulcer on left foot | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE 4.0 | View |
| Other - X2 sore spots to upper right chest | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE 4.0 | View |
| Skin ulceration | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE 4.0 | View |
| Rash acneiform | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE 4.0 | View |
| Other - Skin rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE 4.0 | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE 4.0 | View |
| Other - Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE 4.0 | View |
| Dry skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE 4.0 | View |
| Rash maculo-papular | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE 4.0 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE 4.0 | View |
| Superior vena cava syndrome | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE 4.0 | View |
| Vasculitis | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE 4.0 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE 4.0 | View |
| Thromboembolic event | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE 4.0 | View |