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 @ 5:24 PM
Ignite Modification Date:
2025-12-25 @ 2:58 PM
NCT ID:
NCT02234050
Description:
Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Frequency Threshold:
0
Time Frame:
Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study.
Study:
NCT02234050
Study Brief:
Trabectedin for Recurrent Grade II/III Meningioma
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Trabectedin | Patient will be treated with trabectedin Trabectedin: Trabectedin will be given as a 24-hour infusion every 3 weeks at a starting dose of 1.5 mg/m2 body surface area (BSA), until one of the treatment withdrawal criteria has been met. | 40 | None | 26 | 61 | 58 | 61 | View |
| Local Standard of Care | Treatment in the control arm is left to the discretion of the investigator, according to the local standard of care. Local standard of care: Left to the discretion of the investigator | 17 | None | 4 | 27 | 25 | 27 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (4.0) | View |
| Febrile Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (4.0) | View |
| Other AE | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (4.0) | View |
| Myocarditis | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (4.0) | View |
| Other AE | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | CTCAE (4.0) | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| Other AE | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| Sudden Death Nos | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| Other AE | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | CTCAE (4.0) | View |
| Catheter Related Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.0) | View |
| Lung Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.0) | View |
| Meningitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.0) | View |
| Mucosal Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.0) | View |
| Otitis Externa | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.0) | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.0) | View |
| Upper Respiratory Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.0) | View |
| Urinary Tract Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.0) | View |
| Wound Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.0) | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE (4.0) | View |
| Alanine Aminotransferase Increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| Aspartate Aminotransferase Increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| Cpk Increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| Ggt Increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| Neutrophil Count Decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| Anorexia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.0) | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.0) | View |
| Hyponatremia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.0) | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (4.0) | View |
| Hydrocephalus | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (4.0) | View |
| Intracranial Hemorrhage | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (4.0) | View |
| Ischemia Cerebrovascular | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (4.0) | View |
| Lethargy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (4.0) | View |
| Seizure | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (4.0) | View |
| Somnolence | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (4.0) | View |
| Other AE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (4.0) | View |
| Other AE | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (4.0) | View |
| Thromboembolic Event | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (4.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE(4) | View |
| Febrile Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE(4) | View |
| Other AE | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE(4) | View |
| Myocarditis | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE(4) | View |
| Sinus Tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE(4) | View |
| Ear Pain | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | CTCAE(4) | View |
| Vertigo | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | CTCAE(4) | View |
| Vestibular Disorder | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | CTCAE(4) | View |
| Other AE | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | CTCAE(4) | View |
| Cushingoid | SYSTEMATIC_ASSESSMENT | Endocrine disorders | CTCAE(4) | View |
| Hypothyroidism | SYSTEMATIC_ASSESSMENT | Endocrine disorders | CTCAE(4) | View |
| Blurred Vision | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE(4) | View |
| Eyelid Function Disorder | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE(4) | View |
| Watering Eyes | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE(4) | View |
| Abdominal Pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE(4) | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE(4) | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE(4) | View |
| Dysphagia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE(4) | View |
| Esophageal Pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE(4) | View |
| Fecal Incontinence | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE(4) | View |
| Gastritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE(4) | View |
| Gastroesophageal Reflux Disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE(4) | View |
| Gastrointestinal Pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE(4) | View |
| Mucositis Oral | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE(4) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE(4) | View |
| Periodontal Disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE(4) | View |
| Stomach Pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE(4) | View |
| Toothache | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE(4) | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE(4) | View |
| Other AE | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE(4) | View |
| Chills | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE(4) | View |
| Edema Limbs | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE(4) | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE(4) | View |
| Fever | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE(4) | View |
| Flu Like Symptoms | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE(4) | View |
| Gait Disturbance | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE(4) | View |
| Localized Edema | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE(4) | View |
| Malaise | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE(4) | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE(4) | View |
| Sudden Death Nos | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE(4) | View |
| Other AE | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | CTCAE(4) | View |
| Bladder Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE(4) | View |
| Bronchial Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE(4) | View |
| Catheter Related Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE(4) | View |
| Device Related Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE(4) | View |
| Enterocolitis Infectious | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE(4) | View |
| Eye Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE(4) | View |
| Gum Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE(4) | View |
| Lung Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE(4) | View |
| Meningitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE(4) | View |
| Mucosal Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE(4) | View |
| Otitis Externa | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE(4) | View |
| Paronychia | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE(4) | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE(4) | View |
| Skin Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE(4) | View |
| Upper Respiratory Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE(4) | View |
| Urinary Tract Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE(4) | View |
| Wound Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE(4) | View |
| Other AE | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE(4) | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE(4) | View |
| Fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE(4) | View |
| Alanine Aminotransferase Increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE(4) | View |
| Aspartate Aminotransferase Increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE(4) | View |
| Cpk Increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE(4) | View |
| Ggt Increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE(4) | View |
| Neutrophil Count Decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE(4) | View |
| Serum Amylase Increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE(4) | View |
| Weight Gain | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE(4) | View |
| Weight Loss | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE(4) | View |
| White Blood Cell Decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE(4) | View |
| Anorexia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE(4) | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE(4) | View |
| Hyperglycemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE(4) | View |
| Hyperuricemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE(4) | View |
| Hypokalemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE(4) | View |
| Hypomagnesemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE(4) | View |
| Hyponatremia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE(4) | View |
| Hypophosphatemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE(4) | View |
| Other AE | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE(4) | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE(4) | View |
| Back Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE(4) | View |
| Bone Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE(4) | View |
| Generalized Muscle Weakness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE(4) | View |
| Muscle Weakness Left-Sided | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE(4) | View |
| Muscle Weakness Lower Limb | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE(4) | View |
| Muscle Weakness Right-Sided | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE(4) | View |
| Muscle Weakness Upper Limb | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE(4) | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE(4) | View |
| Myositis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE(4) | View |
| Neck Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE(4) | View |
| Pain In Extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE(4) | View |
| Other AE | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE(4) | View |
| Tumor Pain | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE(4) | View |
| Ataxia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE(4) | View |
| Cerebrospinal Fluid Leakage | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE(4) | View |
| Cognitive Disturbance | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE(4) | View |
| Concentration Impairment | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE(4) | View |
| Depressed Level Of Consciousness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE(4) | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE(4) | View |
| Dysgeusia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE(4) | View |
| Dysphasia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE(4) | View |
| Edema Cerebral | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE(4) | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE(4) | View |
| Hydrocephalus | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE(4) | View |
| Hypersomnia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE(4) | View |
| Intracranial Hemorrhage | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE(4) | View |
| Ischemia Cerebrovascular | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE(4) | View |
| Ivth Nerve Disorder | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE(4) | View |
| Lethargy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE(4) | View |
| Memory Impairment | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE(4) | View |
| Paresthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE(4) | View |
| Peripheral Motor Neuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE(4) | View |
| Peripheral Sensory Neuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE(4) | View |
| Pyramidal Tract Syndrome | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE(4) | View |
| Seizure | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE(4) | View |
| Somnolence | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE(4) | View |
| Stroke | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE(4) | View |
| Tremor | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE(4) | View |
| Trigeminal Nerve Disorder | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE(4) | View |
| Other AE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE(4) | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE(4) | View |
| Confusion | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE(4) | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE(4) | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE(4) | View |
| Other AE | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE(4) | View |
| Acute Kidney Injury | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE(4) | View |
| Proteinuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE(4) | View |
| Urinary Frequency | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE(4) | View |
| Urinary Incontinence | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE(4) | View |
| Genital Edema | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | CTCAE(4) | View |
| Testicular Disorder | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | CTCAE(4) | View |
| Allergic Rhinitis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE(4) | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE(4) | View |
| Dyspnea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE(4) | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE(4) | View |
| Hiccups | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE(4) | View |
| Pneumonitis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE(4) | View |
| Sore Throat | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE(4) | View |
| Other AE | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE(4) | View |
| Alopecia | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE(4) | View |
| Dry Skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE(4) | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE(4) | View |
| Skin Ulceration | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE(4) | View |
| Other AE | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE(4) | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE(4) | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE(4) | View |
| Thromboembolic Event | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE(4) | View |