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:
2025-12-25 @ 3:16 AM
Ignite Modification Date:
2025-12-26 @ 1:55 AM
NCT ID:
NCT00942305
Description:
None
Frequency Threshold:
5
Time Frame:
None
Study:
NCT00942305
Study Brief:
Study of CMX001 to Prevent/Control Cytomegalovirus Infection in R+ Hematopoietic Stem Cell Transplant Recipients
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 BCV | 40 mg brincidofovir (BCV) administered once weekly (QW) | None | None | 12 | 25 | 25 | 25 | View |
| Cohort 1 Placebo | Placebo administered once weekly (QW) | None | None | 4 | 8 | 8 | 8 | View |
| Cohort 2 BCV | 100 mg brincidofovir (BCV) administered once weekly (QW) | None | None | 10 | 27 | 27 | 27 | View |
| Cohort 2 Placebo | Placebo administered once weekly (QW) | None | None | 6 | 10 | 9 | 10 | View |
| Cohort 3 BCV | 200 mg brincidofovir (BCV) administered once weekly (QW) | None | None | 19 | 39 | 39 | 39 | View |
| Cohort 3 Placebo | Placebo administered once weekly (QW) | None | None | 6 | 14 | 14 | 14 | View |
| Cohort 4 BCV | 200 mg brincidofovir (BCV) administered twice weekly (BIW) Note: This dose was reduced to 200 mg BCV once weekly for ongoing subjects in this cohort following the recommendation of the Data and Safety Monitoring Board. No new subjects were enrolled into this cohort following the decision to reduce the dose. | None | None | 21 | 30 | 30 | 30 | View |
| Cohort 4 Placebo | Placebo administered twice weekly (BIW) | None | None | 3 | 10 | 10 | 10 | View |
| Cohort 4a BCV | 100 mg brincidofovir (BCV) administered twice weekly (BIW) | None | None | 30 | 50 | 50 | 50 | View |
| Cohort 4a Placebo | Placebo administered twice weekly (BIW) | None | None | 8 | 17 | 17 | 17 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (12.1) | View |
| Febrile neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (12.1) | View |
| Atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (12.1) | View |
| Atrial flutter | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (12.1) | View |
| Cardiac tamponade | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (12.1) | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (12.1) | View |
| Colitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (12.1) | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (12.1) | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (12.1) | View |
| Diverticulum intestinal haemorrhagic | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (12.1) | View |
| Erosive duodenitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (12.1) | View |
| Gastrointestinal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (12.1) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (12.1) | View |
| Odynophagia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (12.1) | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (12.1) | View |
| Chills | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (12.1) | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (12.1) | View |
| Multi-organ failure | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (12.1) | View |
| Non-cardiac chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (12.1) | View |
| Cholelithiasis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (12.1) | View |
| Liver injury | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (12.1) | View |
| Acute graft versus host disease | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (12.1) | View |
| Acute graft versus host disease in intestine | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.1) | View |
| Acute graft versus host disease in liver | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (12.1) | View |
| Acute graft versus host disease in skin | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (12.1) | View |
| Graft versus host disease | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (12.1) | View |
| Hypersensitivity | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (12.1) | View |
| Appendicitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.1) | View |
| Bacteraemia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.1) | View |
| BK virus infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.1) | View |
| Bronchiolitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.1) | View |
| Bronchopneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.1) | View |
| Catheter related infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.1) | View |
| Cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.1) | View |
| Citrobacter infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.1) | View |
| Clostridium difficile colitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.1) | View |
| Cytomegalovirus colitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.1) | View |
| Cytomegalovirus gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.1) | View |
| Cytomegalovirus infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.1) | View |
| Cytomegalovirus viraemia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.1) | View |
| Epstein-Barr virus infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.1) | View |
| Escherichia sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.1) | View |
| Klebsiella bacteraemia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.1) | View |
| Metapneumovirus infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.1) | View |
| Oral herpes | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.1) | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.1) | View |
| Pneumonia cytomegaloviral | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.1) | View |
| Pneumonia legionella | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.1) | View |
| Pseudomonal bacteraemia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.1) | View |
| Respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.1) | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.1) | View |
| Septic shock | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.1) | View |
| Serratia bacteraemia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.1) | View |
| Staphylococcal bacteraemia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.1) | View |
| Staphylococcal infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.1) | View |
| Staphylococcal sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.1) | View |
| Stenotrophomonas infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.1) | View |
| Streptococcal bacteraemia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.1) | View |
| Viral haemorrhagic cystitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.1) | View |
| Viral sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.1) | View |
| Viral tonsillitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.1) | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (12.1) | View |
| Hip fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (12.1) | View |
| Skin laceration | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (12.1) | View |
| Transplant failure | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (12.1) | View |
| Bacteria stool identified | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (12.1) | View |
| Liver function test abnormal | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (12.1) | View |
| Weight decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (12.1) | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (12.1) | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (12.1) | View |
| Failure to thrive | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (12.1) | View |
| Hyperkalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (12.1) | View |
| Hyponatraemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (12.1) | View |
| Hypovolaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (12.1) | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | View |
| Bone pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | View |
| Chondrocalcinosis pyrophosphate | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | View |
| Myopathy | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | View |
| Acute lymphocytic leukaemia recurrent | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.1) | View |
| Acute myeloid leukaemia recurrent | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.1) | View |
| Chronic lymphocytic leukaemia | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.1) | View |
| Espstein-Barr virus associated lymphoproliferative disorder | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.1) | View |
| Myeloid leukaemia | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.1) | View |
| Non-Hodgkin's lymphoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.1) | View |
| T-cell lymphoma recurrent | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.1) | View |
| Teratoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.1) | View |
| Central nervous system lesion | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (12.1) | View |
| Cerebrovascular accident | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (12.1) | View |
| Cognitive disorder | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (12.1) | View |
| Convulsion | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (12.1) | View |
| Depressed level of consciousness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (12.1) | View |
| Encephalopathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (12.1) | View |
| Leukopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (12.1) | View |
| Lymphopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (12.1) | View |
| Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (12.1) | View |
| Pancytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (12.1) | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (12.1) | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (12.1) | View |
| Cholecytitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (12.1) | View |
| Acute myeloid leukaemia | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.1) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (12.1) | View |
| Febrile neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (12.1) | View |
| Leukocytosis | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (12.1) | View |
| Leukopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (12.1) | View |
| Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (12.1) | View |
| Pancytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (12.1) | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (12.1) | View |
| Haemolytic anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (12.1) | View |
| Lymphadenopathy | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (12.1) | View |
| Aortic valve incompetence | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (12.1) | View |
| Atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (12.1) | View |
| Bradycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (12.1) | View |
| Cardiomegaly | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (12.1) | View |
| Left ventricular hypertrophy | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (12.1) | View |
| Mitral valve incompetence | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (12.1) | View |
| Palpitations | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (12.1) | View |
| Tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (12.1) | View |
| Tricuspid valve incompetence | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (12.1) | View |
| Ear pain | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (12.1) | View |
| Tinnitus | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (12.1) | View |
| Adrenal insufficiency | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA (12.1) | View |
| Conjunctivitis | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (12.1) | View |
| Dry eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (12.1) | View |
| Eye pain | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (12.1) | View |
| Eyelid margin crusting | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (12.1) | View |
| Myodesopsia | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (12.1) | View |
| Vision blurred | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (12.1) | View |
| Vitreous detachment | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (12.1) | View |
| Abdominal discomfort | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (12.1) | View |
| Abdominal distension | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (12.1) | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (12.1) | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (12.1) | View |
| Cheilitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (12.1) | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (12.1) | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (12.1) | View |
| Dry mouth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (12.1) | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (12.1) | View |
| Dysphagia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (12.1) | View |
| Flatulence | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (12.1) | View |
| Gastrooesophageal reflux disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (12.1) | View |
| Haemorrhoids | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (12.1) | View |
| Inguinal hernia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (12.1) | View |
| Mouth ulceration | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (12.1) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (12.1) | View |
| Odynophagia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (12.1) | View |
| Oral disorder | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (12.1) | View |
| Oral pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (12.1) | View |
| Stomatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (12.1) | View |
| Tongue coated | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (12.1) | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (12.1) | View |
| Adverse drug reaction | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (12.1) | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (12.1) | View |
| Chills | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (12.1) | View |
| Early satiety | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (12.1) | View |
| Face oedema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (12.1) | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (12.1) | View |
| Generalised oedema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (12.1) | View |
| Hypothermia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (12.1) | View |
| Non-cardiac chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (12.1) | View |
| Oedema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (12.1) | View |
| Oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (12.1) | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (12.1) | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (12.1) | View |
| Hyperbilirubinaemia | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (12.1) | View |
| Liver injury | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (12.1) | View |
| Acute graft versus host disease | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (12.1) | View |
| Acute graft versus host disease in intestine | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (12.1) | View |
| Acute graft versus host disease in skin | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (12.1) | View |
| Graft versus host disease | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (12.1) | View |
| Hypogammaglobulinaemia | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (12.1) | View |
| Aspergillosis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.1) | View |
| Bacteraemia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.1) | View |
| BK virus infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.1) | View |
| Candidiasis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.1) | View |
| Clostridium difficile colitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.1) | View |
| Cytomegalovirus colitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.1) | View |
| Cytomegalovirus infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.1) | View |
| Cytomegalovirus viraemia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.1) | View |
| Epstein-Barr virus infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.1) | View |
| Escherichia bacteraemia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.1) | View |
| Folliculitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.1) | View |
| Lower respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.1) | View |
| Oral candidiasis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.1) | View |
| Otitis media | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.1) | View |
| Parainfluenzae virus infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.1) | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.1) | View |
| Proctitis herpes | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.1) | View |
| Pseudomonal bacteraemia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.1) | View |
| Staphylococcal bacteraemia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.1) | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.1) | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.1) | View |
| Viral haemorrhagic cystitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.1) | View |
| Ear abrasion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (12.1) | View |
| Excoriation | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (12.1) | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (12.1) | View |
| Spinal fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (12.1) | View |
| Therapeutic agent toxicity | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (12.1) | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (12.1) | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (12.1) | View |
| Blood alkaline phosphatase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (12.1) | View |
| Blood bilirubin increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (12.1) | View |
| Blood creatinine increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (12.1) | View |
| Blood lactate dehydrogenase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (12.1) | View |
| Blood urea increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (12.1) | View |
| Blood urine present | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (12.1) | View |
| Cytomegalovirus test positive | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (12.1) | View |
| Echocardiogram abnormal | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (12.1) | View |
| Gamma-glutamyltransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (12.1) | View |
| Hepatic enzyme increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (12.1) | View |
| Immunosuppressant drug level increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (12.1) | View |
| Liver function test abnormal | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (12.1) | View |
| Neutrophil count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (12.1) | View |
| Platelet count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (12.1) | View |
| Protein total increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (12.1) | View |
| Protein urine present | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (12.1) | View |
| Transaminases increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (12.1) | View |
| Weight decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (12.1) | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (12.1) | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (12.1) | View |
| Diabetes mellitus | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (12.1) | View |
| Electrolyte imbalance | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (12.1) | View |
| Fluid overload | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (12.1) | View |
| Hyperglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (12.1) | View |
| Hyperkalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (12.1) | View |
| Hyperlipidaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (12.1) | View |
| Hypertriglyceridaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (12.1) | View |
| Hypoalbuminaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (12.1) | View |
| Hypocalcaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (12.1) | View |
| Hypoglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (12.1) | View |
| Hypokalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (12.1) | View |
| Hypomagnesaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (12.1) | View |
| Hyponatraemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (12.1) | View |
| Hypophosphataemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (12.1) | View |
| Malnutrition | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (12.1) | View |
| Vitamin D deficiency | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (12.1) | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | View |
| Bone pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | View |
| Bursitis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | View |
| Joint swelling | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | View |
| Muscle spasms | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | View |
| Muscular weakness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | View |
| Musculoskeletal chest pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | View |
| Musculoskeletal discomfort | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | View |
| Musculoskeletal pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | View |
| Myopathy | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | View |
| Osteopenia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | View |
| Rotator cuff syndrome | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | View |
| Acute lymphocytic leukaemia recurrent | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.1) | View |
| Acute myeloid leukaemia recurrent | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.1) | View |
| Myeloid leukaemia | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.1) | View |
| Skin papilloma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.1) | View |
| Convulsion | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (12.1) | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (12.1) | View |
| Dysgeusia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (12.1) | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (12.1) | View |
| Hemiparesis | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (12.1) | View |
| Paraesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (12.1) | View |
| Peropheral sensory neuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (12.1) | View |
| Peroneal nerve palsy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (12.1) | View |
| Tremor | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (12.1) | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (12.1) | View |
| Confusional state | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (12.1) | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (12.1) | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (12.1) | View |
| Mental status changes | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (12.1) | View |
| Mood altered | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (12.1) | View |
| Restlessness | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (12.1) | View |
| Acute prerenal failure | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (12.1) | View |
| Cystitis haemorrhagic | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (12.1) | View |
| Dysuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (12.1) | View |
| Haematuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (12.1) | View |
| Haemorrhage urinary tract | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (12.1) | View |
| Hypertonic bladder | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (12.1) | View |
| Nocturia | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (12.1) | View |
| Pollakiuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (12.1) | View |
| Polyuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (12.1) | View |
| Renal failure | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (12.1) | View |
| Renal failure acute | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (12.1) | View |
| Renal failure chronic | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (12.1) | View |
| Urinary incontinence | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (12.1) | View |
| Atelectasis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | View |
| Dyspnoea exertional | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | View |
| Hypoxia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | View |
| Nasal congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | View |
| Oropharyngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | View |
| Pleural effusion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | View |
| Respiratory disorder | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | View |
| Respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | View |
| Rhinorrhoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | View |
| Sinus congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | View |
| Wheezing | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | View |
| Blister | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (12.1) | View |
| Dermal cyst | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (12.1) | View |
| Erythema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (12.1) | View |
| Hyperkeratosis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (12.1) | View |
| Nail disorder | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (12.1) | View |
| Periorbital oedema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (12.1) | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (12.1) | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (12.1) | View |
| Rash erythematous | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (12.1) | View |
| Rash macular | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (12.1) | View |
| Rash maculo-papular | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (12.1) | View |
| Rash pruritic | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (12.1) | View |
| Skin erosion | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (12.1) | View |
| Skin exfoliation | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (12.1) | View |
| Skin hyperpigmentation | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (12.1) | View |
| Skin irritation | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (12.1) | View |
| Skin lesion | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (12.1) | View |
| Sinus operation | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (12.1) | View |
| Aortic arteriosclerosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (12.1) | View |
| Deep vein thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (12.1) | View |
| Haematoma | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (12.1) | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (12.1) | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (12.1) | View |
| Orthostatic hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (12.1) | View |
| Gastrointestinal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (12.1) | View |
| Cholitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (12.1) | View |
| Multi-organ failure | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (12.1) | View |
| Acute graft versus host disease in liver | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (12.1) | View |
| Escherichia sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.1) | View |
| Klebsiella bacteraemia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.1) | View |
| Septic shock | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.1) | View |
| Serratia bacteraemia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.1) | View |
| Staphylococcal infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.1) | View |
| Viral tonsillitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.1) | View |
| Skin laceration | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (12.1) | View |
| Transplant failure | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (12.1) | View |
| Failure to thrive | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (12.1) | View |
| Chronic lymphocytic leukaemia | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.1) | View |
| Epstein-Barr virus associated lymphoproliferative disorder | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.1) | View |
| Central nervous system lesion | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (12.1) | View |
| Cognitive disorder | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (12.1) | View |
| Depressed level of consciousness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (12.1) | View |
| Encephalopathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (12.1) | View |
| Cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.1) | View |