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 @ 2:48 PM
Ignite Modification Date:
2025-12-25 @ 1:16 PM
NCT ID:
NCT00619359
Description:
Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.
Frequency Threshold:
1
Time Frame:
AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug.
Study:
NCT00619359
Study Brief:
Evaluation of Fosaprepitant (MK0517) in Single Dose Schedule (0517-017)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Fosaprepitant | Fosaprepitant dimeglumine 150 mg IV, ondansetron 32 mg IV, and dexamethasone 12 mg by mouth (PO) on Day 1, dexamethasone 8 mg PO on Day 2, and dexamethasone 16 mg PO on Days 3 and 4. 4 patients from the fosaprepitant regimen were randomized to the study, but discontinued before receiving study drug. These patients were excluded from the Adverse Event tables. | None | None | 148 | 1143 | 636 | 1143 | View |
| Aprepitant | Aprepitant 125 mg by mouth (PO), ondansetron 32 mg IV, and dexamethasone 12 mg PO on Day 1, aprepitant 80 mg PO and dexamethasone 8 mg PO on Days 2 and 3, dexamethasone 8 mg PO on Day 4. 6 patients from the aprepitant regimen were randomized to the study, but discontinued before receiving study drug. These patients were excluded from the Adverse Event tables. | None | None | 157 | 1169 | 679 | 1169 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Death | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 12.0 | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 12.0 | View |
| Anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 12.0 | View |
| Febrile neutropenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 12.0 | View |
| Leukopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 12.0 | View |
| Neutropenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 12.0 | View |
| Pancytopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 12.0 | View |
| Thrombocytopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 12.0 | View |
| Atrial fibrillation | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 12.0 | View |
| Cardiac arrest | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 12.0 | View |
| Cardio-respiratory arrest | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 12.0 | View |
| Cardiopulmonary failure | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 12.0 | View |
| Myocardial infarction | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 12.0 | View |
| Palpitations | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 12.0 | View |
| Supraventricular tachycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 12.0 | View |
| Vertigo | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA Version 12.0 | View |
| Conjunctival haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA Version 12.0 | View |
| Diplopia | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA Version 12.0 | View |
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 12.0 | View |
| Abdominal pain upper | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 12.0 | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 12.0 | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 12.0 | View |
| Duodenal ulcer perforation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 12.0 | View |
| Dysphagia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 12.0 | View |
| Enteritis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 12.0 | View |
| Faecaloma | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 12.0 | View |
| Gastric perforation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 12.0 | View |
| Gastric ulcer haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 12.0 | View |
| Gastric ulcer perforation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 12.0 | View |
| Gastritis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 12.0 | View |
| Gastritis erosive | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 12.0 | View |
| Gastrointestinal haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 12.0 | View |
| Gastrointestinal necrosis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 12.0 | View |
| Haematemesis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 12.0 | View |
| Haematochezia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 12.0 | View |
| Haemorrhoidal haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 12.0 | View |
| Intestinal obstruction | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 12.0 | View |
| Melaena | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 12.0 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 12.0 | View |
| Oesophageal varices haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 12.0 | View |
| Regurgitation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 12.0 | View |
| Stomatitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 12.0 | View |
| Upper gastrointestinal haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 12.0 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 12.0 | View |
| Asthenia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 12.0 | View |
| Chest pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 12.0 | View |
| Mucosal inflammation | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 12.0 | View |
| Non-cardiac chest pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 12.0 | View |
| Pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 12.0 | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 12.0 | View |
| Suprapubic pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 12.0 | View |
| Acute hepatic failure | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA Version 12.0 | View |
| Hepatic failure | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA Version 12.0 | View |
| Hyperbilirubinaemia | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA Version 12.0 | View |
| Abdominal infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 12.0 | View |
| Appendicitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 12.0 | View |
| Bacteraemia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 12.0 | View |
| Cellulitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 12.0 | View |
| Cystitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 12.0 | View |
| Diarrhoea infectious | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 12.0 | View |
| Gastroenteritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 12.0 | View |
| Gastroenteritis shigella | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 12.0 | View |
| Herpes virus infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 12.0 | View |
| Herpes zoster | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 12.0 | View |
| Incision site abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 12.0 | View |
| Lower respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 12.0 | View |
| Oesophageal candidiasis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 12.0 | View |
| Perineal abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 12.0 | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 12.0 | View |
| Postoperative wound infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 12.0 | View |
| Pyelonephritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 12.0 | View |
| Respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 12.0 | View |
| Sepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 12.0 | View |
| Septic shock | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 12.0 | View |
| Upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 12.0 | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 12.0 | View |
| Wound infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 12.0 | View |
| Tracheal obstruction | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 12.0 | View |
| Wound dehiscence | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 12.0 | View |
| Alanine aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 12.0 | View |
| Aspartate aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 12.0 | View |
| Blood creatinine increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 12.0 | View |
| Blood potassium decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 12.0 | View |
| Haemoglobin decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 12.0 | View |
| Liver function test abnormal | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 12.0 | View |
| Neutrophil count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 12.0 | View |
| Anorexia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 12.0 | View |
| Dehydration | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 12.0 | View |
| Diabetes mellitus | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 12.0 | View |
| Hyperglycaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 12.0 | View |
| Hypokalaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 12.0 | View |
| Hyponatraemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 12.0 | View |
| Malnutrition | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 12.0 | View |
| Flank pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 12.0 | View |
| Lung neoplasm malignant | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 12.0 | View |
| Malignant neoplasm progression | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 12.0 | View |
| Metastases to central nervous system | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 12.0 | View |
| Paraneoplastic syndrome | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 12.0 | View |
| Tumour haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 12.0 | View |
| Cerebral ischaemia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 12.0 | View |
| Cerebrovascular accident | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 12.0 | View |
| Cognitive disorder | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 12.0 | View |
| Convulsion | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 12.0 | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 12.0 | View |
| Haemorrhage intracranial | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 12.0 | View |
| Ischaemic stroke | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 12.0 | View |
| Spinal cord compression | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 12.0 | View |
| Disorientation | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 12.0 | View |
| Psychotic disorder | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 12.0 | View |
| Hydronephrosis | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 12.0 | View |
| Renal failure | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 12.0 | View |
| Renal failure acute | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 12.0 | View |
| Renal failure chronic | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 12.0 | View |
| Renal impairment | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 12.0 | View |
| Urinary retention | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 12.0 | View |
| Aspiration | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 12.0 | View |
| Choking | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 12.0 | View |
| Dyspnoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 12.0 | View |
| Epistaxis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 12.0 | View |
| Haemoptysis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 12.0 | View |
| Hiccups | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 12.0 | View |
| Hydropneumothorax | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 12.0 | View |
| Pleural effusion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 12.0 | View |
| Pneumonia aspiration | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 12.0 | View |
| Pneumonitis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 12.0 | View |
| Pulmonary embolism | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 12.0 | View |
| Pulmonary thrombosis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 12.0 | View |
| Respiratory arrest | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 12.0 | View |
| Respiratory distress | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 12.0 | View |
| Respiratory failure | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 12.0 | View |
| Erythema | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 12.0 | View |
| Arterial occlusive disease | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 12.0 | View |
| Arterial thrombosis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 12.0 | View |
| Arteriosclerosis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 12.0 | View |
| Deep vein thrombosis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 12.0 | View |
| Flushing | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 12.0 | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 12.0 | View |
| Hypertensive crisis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 12.0 | View |
| Hypotension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 12.0 | View |
| Orthostatic hypotension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 12.0 | View |
| Peripheral arterial occlusive disease | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 12.0 | View |
| Peripheral embolism | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 12.0 | View |
| Thrombosis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 12.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 12.0 | View |
| Leukopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 12.0 | View |
| Neutropenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 12.0 | View |
| Thrombocytopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 12.0 | View |
| Tinnitus | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA Version 12.0 | View |
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 12.0 | View |
| Abdominal pain upper | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 12.0 | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 12.0 | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 12.0 | View |
| Dyspepsia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 12.0 | View |
| Gastritis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 12.0 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 12.0 | View |
| Stomatitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 12.0 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 12.0 | View |
| Asthenia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 12.0 | View |
| Chest pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 12.0 | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 12.0 | View |
| Infusion site pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 12.0 | View |
| Mucosal inflammation | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 12.0 | View |
| Pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 12.0 | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 12.0 | View |
| Accidental overdose | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 12.0 | View |
| Alanine aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 12.0 | View |
| Blood creatinine increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 12.0 | View |
| Anorexia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 12.0 | View |
| Dehydration | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 12.0 | View |
| Hypokalaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 12.0 | View |
| Hyponatraemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 12.0 | View |
| Myalgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 12.0 | View |
| Pain in extremity | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 12.0 | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 12.0 | View |
| Dysgeusia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 12.0 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 12.0 | View |
| Insomnia | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 12.0 | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 12.0 | View |
| Dyspnoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 12.0 | View |
| Hiccups | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 12.0 | View |
| Alopecia | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 12.0 | View |
| Erythema | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 12.0 | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 12.0 | View |
| Hypotension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 12.0 | View |