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 @ 9:12 PM
Ignite Modification Date:
2025-12-25 @ 7:01 PM
NCT ID:
NCT02541604
Description:
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
Frequency Threshold:
5
Time Frame:
From baseline up to approximately 42 months
Study:
NCT02541604
Study Brief:
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Preliminary Efficacy of Atezolizumab (Anti-Programmed Death-Ligand 1 [PD-L1] Antibody) in Pediatric and Young Adult Participants With Solid Tumors
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| COHORT 1 | EWING SARCOMA | 6 | None | 4 | 11 | 11 | 11 | View |
| COHORT 2 | HODGKIN LYMPHOMA | 5 | None | 3 | 9 | 8 | 9 | View |
| COHORT 3 | NEUROBLASTOMA | 7 | None | 2 | 11 | 11 | 11 | View |
| COHORT 4 | NON HODGKIN LYMPHOMA | 2 | None | 0 | 3 | 3 | 3 | View |
| COHORT 5 | NON-RHABDOMYOSARCOMA SOFT TISSUE SARCOMA; | 9 | None | 3 | 10 | 10 | 10 | View |
| COHORT 6 | OSTEOSARCOMA | 8 | None | 6 | 10 | 10 | 10 | View |
| COHORT 7 | RHABDOMYOSARCOMA | 9 | None | 3 | 10 | 10 | 10 | View |
| COHORT 8 | WILMS TUMOR | 9 | None | 5 | 10 | 10 | 10 | View |
| COHORT 9 | OTHER TUMOR TYPES WITH DOCUMENTED PD-L1 EXPRESSION | 3 | None | 2 | 4 | 4 | 4 | View |
| COHORT 10 | OTHER TUMOR TYPES WITHOUT DOCUMENTED PD-L1 EXPRESSION | 4 | None | 3 | 4 | 3 | 4 | View |
| COHORT 11 | RHABDOID TUMOR | 2 | None | 1 | 2 | 2 | 2 | View |
| COHORT 12 | ATYPICAL TERATOID RHABDOID TUMOR | 3 | None | 1 | 3 | 2 | 3 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| ANAEMIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA version 22.0 | View |
| FEBRILE NEUTROPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA version 22.0 | View |
| PAPILLOEDEMA | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA version 22.0 | View |
| ABDOMINAL DISTENSION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 22.0 | View |
| CONSTIPATION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 22.0 | View |
| LARGE INTESTINAL OBSTRUCTION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 22.0 | View |
| PANCREATITIS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 22.0 | View |
| UPPER GASTROINTESTINAL HAEMORRHAGE | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 22.0 | View |
| CHEST PAIN | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 22.0 | View |
| FATIGUE | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 22.0 | View |
| PAIN | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 22.0 | View |
| PYREXIA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 22.0 | View |
| CHOLESTASIS | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA version 22.0 | View |
| GRAFT VERSUS HOST DISEASE | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA version 22.0 | View |
| ABDOMINAL ABSCESS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 22.0 | View |
| DEVICE RELATED INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 22.0 | View |
| INCISION SITE ABSCESS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 22.0 | View |
| LUNG INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 22.0 | View |
| POSTOPERATIVE ABSCESS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 22.0 | View |
| PYELONEPHRITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 22.0 | View |
| RESPIRATORY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 22.0 | View |
| SEPTIC SHOCK | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 22.0 | View |
| STAPHYLOCOCCAL SEPSIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 22.0 | View |
| URINARY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 22.0 | View |
| POSTOPERATIVE HYPOTENSION | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 22.0 | View |
| TOXICITY TO VARIOUS AGENTS | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 22.0 | View |
| DEHYDRATION | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA version 22.0 | View |
| DIABETIC KETOACIDOSIS | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA version 22.0 | View |
| HYPONATRAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA version 22.0 | View |
| BONE PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA version 22.0 | View |
| FLANK PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA version 22.0 | View |
| HEADACHE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 22.0 | View |
| HYDROCEPHALUS | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 22.0 | View |
| PARAESTHESIA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 22.0 | View |
| VITH NERVE DISORDER | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 22.0 | View |
| AGITATION | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA version 22.0 | View |
| HYDRONEPHROSIS | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA version 22.0 | View |
| URINARY TRACT OBSTRUCTION | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA version 22.0 | View |
| DYSPNOEA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 22.0 | View |
| PLEURAL EFFUSION | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 22.0 | View |
| PNEUMOTHORAX | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 22.0 | View |
| PRURITUS | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA version 22.0 | View |
| RASH MACULO-PAPULAR | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA version 22.0 | View |
| TOXIC SKIN ERUPTION | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA version 22.0 | View |
| SHOCK HAEMORRHAGIC | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA version 22.0 | View |
| SUPERIOR VENA CAVA SYNDROME | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA version 22.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| ANAEMIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA version 22.0 | View |
| FEBRILE NEUTROPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA version 22.0 | View |
| LEUKOPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA version 22.0 | View |
| LYMPHADENOPATHY | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA version 22.0 | View |
| LYMPHOPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA version 22.0 | View |
| NEUTROPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA version 22.0 | View |
| THROMBOCYTOPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA version 22.0 | View |
| THROMBOCYTOSIS | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA version 22.0 | View |
| PERICARDIAL EFFUSION | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA version 22.0 | View |
| SINUS TACHYCARDIA | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA version 22.0 | View |
| TACHYCARDIA | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA version 22.0 | View |
| FANCONI SYNDROME | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA version 22.0 | View |
| EAR PAIN | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA version 22.0 | View |
| VERTIGO | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA version 22.0 | View |
| HYPERTHYROIDISM | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA version 22.0 | View |
| HYPOTHYROIDISM | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA version 22.0 | View |
| ECZEMA EYELIDS | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA version 22.0 | View |
| EYELID PTOSIS | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA version 22.0 | View |
| OPSOCLONUS MYOCLONUS | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA version 22.0 | View |
| PERIORBITAL OEDEMA | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA version 22.0 | View |
| PHOTOPHOBIA | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA version 22.0 | View |
| PHOTOPSIA | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA version 22.0 | View |
| VISION BLURRED | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA version 22.0 | View |
| ABDOMINAL PAIN | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 22.0 | View |
| ABDOMINAL PAIN LOWER | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 22.0 | View |
| ABDOMINAL PAIN UPPER | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 22.0 | View |
| ANAL INCONTINENCE | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 22.0 | View |
| ASCITES | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 22.0 | View |
| COLITIS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 22.0 | View |
| CONSTIPATION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 22.0 | View |
| DENTAL CARIES | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 22.0 | View |
| DIARRHOEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 22.0 | View |
| DYSPEPSIA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 22.0 | View |
| DYSPHAGIA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 22.0 | View |
| ENTEROCOLITIS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 22.0 | View |
| HAEMATOCHEZIA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 22.0 | View |
| LIP ULCERATION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 22.0 | View |
| NAUSEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 22.0 | View |
| NONINFECTIVE GINGIVITIS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 22.0 | View |
| ODYNOPHAGIA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 22.0 | View |
| ORAL PAIN | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 22.0 | View |
| PROCTALGIA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 22.0 | View |
| RECTAL DISCHARGE | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 22.0 | View |
| STOMATITIS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 22.0 | View |
| SUBILEUS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 22.0 | View |
| SWOLLEN TONGUE | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 22.0 | View |
| UPPER GASTROINTESTINAL HAEMORRHAGE | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 22.0 | View |
| VOMITING | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 22.0 | View |
| ASTHENIA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 22.0 | View |
| AXILLARY PAIN | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 22.0 | View |
| CATHETER SITE ERYTHEMA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 22.0 | View |
| CHEST DISCOMFORT | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 22.0 | View |
| CHEST PAIN | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 22.0 | View |
| CHILLS | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 22.0 | View |
| FACE OEDEMA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 22.0 | View |
| FATIGUE | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 22.0 | View |
| GENERALISED OEDEMA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 22.0 | View |
| INFLUENZA LIKE ILLNESS | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 22.0 | View |
| MALAISE | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 22.0 | View |
| NON-CARDIAC CHEST PAIN | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 22.0 | View |
| OEDEMA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 22.0 | View |
| OEDEMA PERIPHERAL | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 22.0 | View |
| PAIN | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 22.0 | View |
| PERIPHERAL SWELLING | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 22.0 | View |
| PYREXIA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 22.0 | View |
| THIRST | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 22.0 | View |
| VACCINATION SITE OEDEMA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 22.0 | View |
| HYPERBILIRUBINAEMIA | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA version 22.0 | View |
| BACTERAEMIA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 22.0 | View |
| BRONCHITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 22.0 | View |
| CANDIDA URETHRITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 22.0 | View |
| CONJUNCTIVITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 22.0 | View |
| DERMATOPHYTOSIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 22.0 | View |
| DEVICE RELATED INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 22.0 | View |
| FUNGAL SKIN INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 22.0 | View |
| GENITAL HERPES | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 22.0 | View |
| HERPES VIRUS INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 22.0 | View |
| INFLUENZA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 22.0 | View |
| LARYNGITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 22.0 | View |
| LUNG INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 22.0 | View |
| NASOPHARYNGITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 22.0 | View |
| ORAL CANDIDIASIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 22.0 | View |
| ORAL HERPES | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 22.0 | View |
| PARONYCHIA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 22.0 | View |
| PHARYNGITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 22.0 | View |
| PYELONEPHRITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 22.0 | View |
| RHINITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 22.0 | View |
| SKIN INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 22.0 | View |
| STAPHYLOCOCCAL | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 22.0 | View |
| TONSILLITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 22.0 | View |
| UPPER RESPIRATORY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 22.0 | View |
| URINARY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 22.0 | View |
| VASCULAR DEVICE INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 22.0 | View |
| VULVITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 22.0 | View |
| ARTHROPOD BITE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 22.0 | View |
| FALL | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 22.0 | View |
| LIMB INJURY | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 22.0 | View |
| POST PROCEDURAL SWELLING | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 22.0 | View |
| PROCEDURAL PAIN | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 22.0 | View |
| THERMAL BURN | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 22.0 | View |
| UROSTOMY COMPLICATION | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 22.0 | View |
| WOUND DEHISCENCE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 22.0 | View |
| ALANINE AMINOTRANSFERASE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 22.0 | View |
| AMYLASE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 22.0 | View |
| ANTITHROMBIN III DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 22.0 | View |
| ASPARTATE AMINOTRANSFERASE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 22.0 | View |
| BLOOD ALKALINE PHOSPHATASE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 22.0 | View |
| BLOOD BILIRUBIN INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 22.0 | View |
| BLOOD CHLORIDE DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 22.0 | View |
| BLOOD CREATININE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 22.0 | View |
| BLOOD LACTATE DEHYDROGENASE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 22.0 | View |
| BLOOD POTASSIUM DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 22.0 | View |
| BLOOD THYROID STIMULATING HORMONE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 22.0 | View |
| BLOOD URINE PRESENT | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 22.0 | View |
| C-REACTIVE PROTEIN INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 22.0 | View |
| CANDIDA TEST POSITIVE | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 22.0 | View |
| CARDIAC MURMUR | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 22.0 | View |
| GAMMA-GLUTAMYLTRANSFERASE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 22.0 | View |
| INTERNATIONAL NORMALISED RATIO INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 22.0 | View |
| LIPASE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 22.0 | View |
| LYMPHOCYTE COUNT DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 22.0 | View |
| NEUTROPHIL COUNT DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 22.0 | View |
| NOROVIRUS TEST POSITIVE | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 22.0 | View |
| OXYGEN SATURATION DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 22.0 | View |
| PLATELET COUNT DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 22.0 | View |
| PROTHROMBIN LEVEL DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 22.0 | View |
| VITAMIN K DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 22.0 | View |
| WEIGHT DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 22.0 | View |
| WHITE BLOOD CELL COUNT DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 22.0 | View |
| DECREASED APPETITE | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA version 22.0 | View |
| DEHYDRATION | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA version 22.0 | View |
| HYPERGLYCAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA version 22.0 | View |
| HYPERKALAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA version 22.0 | View |
| HYPERNATRAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA version 22.0 | View |
| HYPERTRIGLYCERIDAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA version 22.0 | View |
| HYPERURICAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA version 22.0 | View |
| HYPOALBUMINAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA version 22.0 | View |
| HYPOCALCAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA version 22.0 | View |
| HYPOKALAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA version 22.0 | View |
| HYPOMAGNESAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA version 22.0 | View |
| HYPONATRAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA version 22.0 | View |
| HYPOPHOSPHATAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA version 22.0 | View |
| METABOLIC ACIDOSIS | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA version 22.0 | View |
| ARTHRALGIA | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA version 22.0 | View |
| BACK PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA version 22.0 | View |
| FLANK PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA version 22.0 | View |
| HAEMARTHROSIS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA version 22.0 | View |
| MUSCLE SPASMS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA version 22.0 | View |
| MUSCULOSKELETAL PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA version 22.0 | View |
| MYALGIA | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA version 22.0 | View |
| NECK PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA version 22.0 | View |
| PAIN IN EXTREMITY | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA version 22.0 | View |
| PAIN IN JAW | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA version 22.0 | View |
| TUMOUR INFLAMMATION | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 22.0 | View |
| TUMOUR PAIN | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 22.0 | View |
| AMPUTATION STUMP PAIN | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 22.0 | View |
| DYSGEUSIA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 22.0 | View |
| HEADACHE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 22.0 | View |
| HYPOAESTHESIA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 22.0 | View |
| MIGRAINE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 22.0 | View |
| MIGRAINE WITH AURA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 22.0 | View |
| NEURALGIA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 22.0 | View |
| PARAESTHESIA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 22.0 | View |
| PHANTOM LIMB SYNDROME | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 22.0 | View |
| SEIZURE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 22.0 | View |
| SOMNOLENCE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 22.0 | View |
| TREMOR | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 22.0 | View |
| DEVICE BREAKAGE | SYSTEMATIC_ASSESSMENT | Product Issues | MedDRA version 22.0 | View |
| AGITATION | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA version 22.0 | View |
| ANXIETY | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA version 22.0 | View |
| BRUXISM | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA version 22.0 | View |
| CONFUSIONAL STATE | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA version 22.0 | View |
| DELIRIUM | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA version 22.0 | View |
| DEPRESSION | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA version 22.0 | View |
| INSOMNIA | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA version 22.0 | View |
| IRRITABILITY | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA version 22.0 | View |
| SLEEP DISORDER | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA version 22.0 | View |
| ACUTE KIDNEY INJURY | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA version 22.0 | View |
| DYSURIA | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA version 22.0 | View |
| GLYCOSURIA | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA version 22.0 | View |
| HAEMATURIA | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA version 22.0 | View |
| HYDRONEPHROSIS | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA version 22.0 | View |
| NEPHROLITHIASIS | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA version 22.0 | View |
| OLIGURIA | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA version 22.0 | View |
| PROTEINURIA | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA version 22.0 | View |
| URINARY INCONTINENCE | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA version 22.0 | View |
| PELVIC PAIN | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA version 22.0 | View |
| VAGINAL DISCHARGE | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA version 22.0 | View |
| VAGINAL HAEMORRHAGE | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA version 22.0 | View |
| CATARRH | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 22.0 | View |
| COUGH | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 22.0 | View |
| DYSPHONIA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 22.0 | View |
| DYSPNOEA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 22.0 | View |
| DYSPNOEA EXERTIONAL | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 22.0 | View |
| EPISTAXIS | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 22.0 | View |
| HYPOXIA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 22.0 | View |
| IRREGULAR BREATHING | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 22.0 | View |
| LARYNGEAL INFLAMMATION | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 22.0 | View |
| NASAL CONGESTION | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 22.0 | View |
| DISORDER OROPHARYNGEAL PAIN | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 22.0 | View |
| PHARYNGEAL INFLAMMATION | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 22.0 | View |
| PLEURAL EFFUSION | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 22.0 | View |
| PNEUMONITIS | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 22.0 | View |
| RHINITIS ALLERGIC | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 22.0 | View |
| STRIDOR | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 22.0 | View |
| TACHYPNOEA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 22.0 | View |
| ALOPECIA | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA version 22.0 | View |
| BLISTER | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA version 22.0 | View |
| DERMATITIS | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA version 22.0 | View |
| DERMATITIS CONTACT | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA version 22.0 | View |
| DRY SKIN | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA version 22.0 | View |
| ECZEMA | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA version 22.0 | View |
| ERYTHEMA | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA version 22.0 | View |
| HYPERHIDROSIS | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA version 22.0 | View |
| PALMAR-PLANTAR | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA version 22.0 | View |
| ERYTHRODYSAESTHESIA SYNDROME | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA version 22.0 | View |
| PERIORAL DERMATITIS | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA version 22.0 | View |
| PETECHIAE | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA version 22.0 | View |
| PITYRIASIS ROSEA | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA version 22.0 | View |
| PRURITUS | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA version 22.0 | View |
| RASH | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA version 22.0 | View |
| RASH MACULO-PAPULAR | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA version 22.0 | View |
| RASH PRURITIC | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA version 22.0 | View |
| SKIN DISCOLOURATION | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA version 22.0 | View |
| URTICARIA | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA version 22.0 | View |
| CENTRAL VENOUS CATHETERISATION | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA version 22.0 | View |
| EMBOLISM | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA version 22.0 | View |
| HOT FLUSH | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA version 22.0 | View |
| HYPERTENSION | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA version 22.0 | View |
| HYPOTENSION | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA version 22.0 | View |
| HYPOVOLAEMIC SHOCK | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA version 22.0 | View |
| VENOUS THROMBOSIS | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA version 22.0 | View |
| CONTUSION | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 22.0 | View |
| HYPERMAGNESAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA version 22.0 | View |
| JOINT SWELLING | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA version 22.0 | View |
| DIZZINESS | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 22.0 | View |
| PARAPARESIS | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 22.0 | View |
| ABNORMAL BEHAVIOUR | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA version 22.0 | View |
| URINARY RETENTION | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA version 22.0 | View |
| ATELECTASIS | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 22.0 | View |
| OBSTRUCTIVE AIRWAYS DISORDER | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 22.0 | View |
| OROPHARYNGEAL PAIN | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 22.0 | View |
| RHINORRHOEA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 22.0 | View |