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:
2025-12-26 @ 10:17 PM
Ignite Modification Date:
2025-12-26 @ 10:17 PM
NCT ID:
NCT01271712
Description:
At primary completion (cutoff 26JAN2012) blinded patients who received either regorafenib or placebo were reported in "Regorafenib (DoubleBlindOnly)" and "Placebo (DoubleBlindOnly)" respectively; patients who received regorafenib after unblinding were reported in "Placebo, OpenLabelOnly(Switch to Regorafenib)". This safety update (cutoff 15APR2019) was reported in "Treated with Regorafenib at any time" and "Treated with Regorafenib for\>1 year".
Frequency Threshold:
5
Time Frame:
From first administration of treatment till 30 days after last dose of treatment.
Study:
NCT01271712
Study Brief:
Study of Regorafenib as a 3rd-line or Beyond Treatment for Gastrointestinal Stromal Tumors (GIST)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Regorafenib (Double Blind Only) | Participants received Regorafenib (Stivarga) 160 mg (4 x 40 mg tablets) per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks | 40 | None | 23 | 41 | 40 | 41 | View |
| Placebo (Double Blind Only) | Participants received matching Placebo tablets per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks | 7 | None | 8 | 8 | 7 | 8 | View |
| Placebo, Open Label Only (Switch to Regorafenib) | Participants switched to Open-label Regorafenib treatment from Placebo. Participants received Regorafenib (Stivarga) 160 mg (4 x 40 mg tablets) per os once daily, 3 weeks | 47 | None | 31 | 58 | 58 | 58 | View |
| Treated With Regorafenib at Any Time | Treated with Regorafenib at any time: At any time, participants received Regorafenib (Stivarga) 160 mg (4 x 40 mg tablets) per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks | 155 | None | 103 | 190 | 189 | 190 | View |
| Treated With Regorafenib for > 1 Year | Treated with Regorafenib for \> 1 year: For more than a year, participants received Regorafenib (Stivarga) 160 mg (4 x 40 mg tablets) per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks | 48 | None | 39 | 75 | 75 | 75 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Vertigo | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (22.0) | View |
| Anemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (22.0) | View |
| Congenital, familial and genetic disorders - Other | NON_SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA (22.0) | View |
| Acute coronary syndrome | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (22.0) | View |
| Atrial fibrillation | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (22.0) | View |
| Cardiac arrest | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (22.0) | View |
| Chest pain - cardiac | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (22.0) | View |
| Conduction disorder | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (22.0) | View |
| Heart failure | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (22.0) | View |
| Cardiac disorders - Other | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (22.0) | View |
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (22.0) | View |
| Anal fistula | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (22.0) | View |
| Ascites | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (22.0) | View |
| Colonic fistula | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (22.0) | View |
| Colonic obstruction | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (22.0) | View |
| Colonic perforation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (22.0) | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (22.0) | View |
| Diarrhea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (22.0) | View |
| Gastric hemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (22.0) | View |
| Intra-abdominal hemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (22.0) | View |
| Ileus | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (22.0) | View |
| Lower gastrointestinal hemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (22.0) | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (22.0) | View |
| Obstruction gastric | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (22.0) | View |
| Gastrointestinal disorders - Other | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (22.0) | View |
| Peritoneal necrosis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (22.0) | View |
| Retroperitoneal hemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (22.0) | View |
| Small intestinal obstruction | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (22.0) | View |
| Upper gastrointestinal hemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (22.0) | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (22.0) | View |
| Death NOS | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (22.0) | View |
| Edema limbs | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (22.0) | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (22.0) | View |
| Fever | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (22.0) | View |
| Malaise | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (22.0) | View |
| Multi-organ failure | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (22.0) | View |
| Non-cardiac chest pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (22.0) | View |
| General disorders and administration site conditions - Other | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (22.0) | View |
| Pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (22.0) | View |
| Bile duct stenosis | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (22.0) | View |
| Cholecystitis | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (22.0) | View |
| Hepatic failure | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (22.0) | View |
| Hepatic hemorrhage | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (22.0) | View |
| Hepatobiliary disorders - Other | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (22.0) | View |
| Portal vein thrombosis | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (22.0) | View |
| Alanine aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (22.0) | View |
| Aspartate aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (22.0) | View |
| Blood bilirubin increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (22.0) | View |
| Creatinine increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (22.0) | View |
| INR increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (22.0) | View |
| Neutrophil count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (22.0) | View |
| Investigations - Other | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (22.0) | View |
| Platelet count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (22.0) | View |
| Abdominal infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (22.0) | View |
| Appendicitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (22.0) | View |
| Bronchial infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (22.0) | View |
| Catheter related infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (22.0) | View |
| Enterocolitis infectious | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (22.0) | View |
| Lung infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (22.0) | View |
| Infections and infestations - Other | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (22.0) | View |
| Sepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (22.0) | View |
| Upper respiratory infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (22.0) | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (22.0) | View |
| Wound infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (22.0) | View |
| Fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (22.0) | View |
| Hip fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (22.0) | View |
| Acidosis | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (22.0) | View |
| Anorexia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (22.0) | View |
| Dehydration | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (22.0) | View |
| Hyperglycemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (22.0) | View |
| Hyperkalemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (22.0) | View |
| Back pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | View |
| Generalized muscle weakness | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | View |
| Musculoskeletal and connective tissue disorder - Other | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | View |
| Muscle weakness right-sided | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | View |
| Amnesia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (22.0) | View |
| Hypoglossal nerve disorder | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (22.0) | View |
| Intracranial hemorrhage | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (22.0) | View |
| Nervous system disorders - Other | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (22.0) | View |
| Paresthesia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (22.0) | View |
| Reversible posterior leukoencephalopathy syndrome | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (22.0) | View |
| Somnolence | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (22.0) | View |
| Stroke | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (22.0) | View |
| Transient ischemic attacks | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (22.0) | View |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (22.0) | View |
| Tumor pain | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (22.0) | View |
| Eye disorders - Other | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (22.0) | View |
| Confusion | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (22.0) | View |
| Mania | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (22.0) | View |
| Psychiatric disorders - Other | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (22.0) | View |
| Adult respiratory distress syndrome | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | View |
| Dyspnea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | View |
| Pleural effusion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | View |
| Pneumonitis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | View |
| Respiratory failure | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | View |
| Acute kidney injury | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (22.0) | View |
| Renal and urinary disorders - Other | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (22.0) | View |
| Renal colic | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (22.0) | View |
| Urinary retention | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (22.0) | View |
| Rash maculo-papular | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (22.0) | View |
| Surgical and medical procedures - Other | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (22.0) | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (22.0) | View |
| Vascular disorders - Other | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (22.0) | View |
| Peripheral ischemia | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (22.0) | View |
| Thromboembolic event | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (22.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Hearing impaired | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (22.0) | View |
| Ear and labyrinth disorders - Other | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (22.0) | View |
| Anemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (22.0) | View |
| Blood and lymphatic system disorders - Other | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (22.0) | View |
| Hypothyroidism | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA (22.0) | View |
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (22.0) | View |
| Ascites | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (22.0) | View |
| Bloating | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (22.0) | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (22.0) | View |
| Diarrhea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (22.0) | View |
| Dyspepsia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (22.0) | View |
| Dry mouth | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (22.0) | View |
| Flatulence | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (22.0) | View |
| Mucositis oral | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (22.0) | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (22.0) | View |
| Gastrointestinal disorders - Other | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (22.0) | View |
| Stomach pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (22.0) | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (22.0) | View |
| Chills | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (22.0) | View |
| Edema limbs | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (22.0) | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (22.0) | View |
| Fever | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (22.0) | View |
| Flu like symptoms | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (22.0) | View |
| Localized edema | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (22.0) | View |
| Non-cardiac chest pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (22.0) | View |
| General disorders and administration site conditions - Other | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (22.0) | View |
| Pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (22.0) | View |
| Alanine aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (22.0) | View |
| Alkaline phosphatase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (22.0) | View |
| Aspartate aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (22.0) | View |
| Blood bilirubin increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (22.0) | View |
| GGT increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (22.0) | View |
| Lipase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (22.0) | View |
| Neutrophil count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (22.0) | View |
| Investigations - Other | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (22.0) | View |
| Platelet count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (22.0) | View |
| White blood cell decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (22.0) | View |
| Weight gain | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (22.0) | View |
| Weight loss | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (22.0) | View |
| Allergic reaction | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (22.0) | View |
| Bronchial infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (22.0) | View |
| Infections and infestations - Other | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (22.0) | View |
| Rash pustular | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (22.0) | View |
| Sinusitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (22.0) | View |
| Skin infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (22.0) | View |
| Tooth infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (22.0) | View |
| Upper respiratory infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (22.0) | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (22.0) | View |
| Anorexia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (22.0) | View |
| Dehydration | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (22.0) | View |
| Hypoalbuminemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (22.0) | View |
| Hypocalcemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (22.0) | View |
| Hypokalemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (22.0) | View |
| Hyponatremia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (22.0) | View |
| Hypophosphatemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (22.0) | View |
| Hypercalcemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (22.0) | View |
| Hyperglycemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (22.0) | View |
| Hyperuricemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (22.0) | View |
| Arthralgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | View |
| Back pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | View |
| Bone pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | View |
| Flank pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | View |
| Generalized muscle weakness | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | View |
| Myalgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | View |
| Neck pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | View |
| Musculoskeletal and connective tissue disorder - Other | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | View |
| Pain in extremity | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (22.0) | View |
| Dysgeusia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (22.0) | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (22.0) | View |
| Paresthesia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (22.0) | View |
| Peripheral sensory neuropathy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (22.0) | View |
| Somnolence | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (22.0) | View |
| Tumor pain | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (22.0) | View |
| Blurred vision | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (22.0) | View |
| Eye disorders - Other | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (22.0) | View |
| Anxiety | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (22.0) | View |
| Confusion | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (22.0) | View |
| Depression | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (22.0) | View |
| Insomnia | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (22.0) | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | View |
| Dyspnea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | View |
| Epistaxis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | View |
| Hiccups | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | View |
| Hoarseness | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | View |
| Pneumonitis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | View |
| Voice alteration | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | View |
| Hematuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (22.0) | View |
| Renal and urinary disorders - Other | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (22.0) | View |
| Proteinuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (22.0) | View |
| Urinary frequency | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (22.0) | View |
| Alopecia | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (22.0) | View |
| Dry skin | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (22.0) | View |
| Erythema multiforme | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (22.0) | View |
| Erythroderma | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (22.0) | View |
| Hyperhidrosis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (22.0) | View |
| Skin and subcutaneous tissue disorders - Other | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (22.0) | View |
| Pain of skin | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (22.0) | View |
| Palmar-plantar erythrodysesthesia syndrome | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (22.0) | View |
| Pruritus | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (22.0) | View |
| Rash acneiform | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (22.0) | View |
| Rash maculo-papular | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (22.0) | View |
| Hypotension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (22.0) | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (22.0) | View |
| Thromboembolic event | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (22.0) | View |