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 @ 11:11 PM
Ignite Modification Date:
2025-12-25 @ 8:45 PM
NCT ID:
NCT03541369
Description:
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
Frequency Threshold:
5
Time Frame:
For all-cause mortality, from enrollment to end of study; median time on study was 1.347 months. Adverse events were reported from first dose of investigational product (day 1 cycle 1) to 30 days after last dose of investigational product or end of study; median treatment duration was 0.62 months.
Study:
NCT03541369
Study Brief:
Safety, Tolerability, PK, PD, and Efficacy of AMG 427 in Subjects With Relapsed/Refractory Acute Myeloid Leukemia
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 (FIH): Emirodatamab Dose A | Emirodatamab Dose A was administered as an IV infusion in a 2-week cycle with no step dosing. Dexamethasone 8 mg IV was administered within 1 hour before dosing. | 0 | None | 1 | 1 | 1 | 1 | View |
| Cohort 2 (FIH): Emirodatamab Dose B | Emirodatamab Dose B was administered as an IV infusion in a 2-week cycle with no step dosing. Dexamethasone 8 mg IV was administered within 1 hour before dosing. | 0 | None | 1 | 1 | 1 | 1 | View |
| Cohort 3 (FIH): Emirodatamab Dose C | Emirodatamab Dose C was administered as an IV infusion in a 2-week cycle with no step dosing. Dexamethasone 8 mg IV was administered within 1 hour before dosing. | 0 | None | 0 | 1 | 1 | 1 | View |
| Cohort 4 (FIH): Emirodatamab Dose D | Emirodatamab Dose D was administered as an IV infusion in a 2-week cycle with no step dosing. Dexamethasone 8 mg IV was administered within 1 hour before dosing. | 0 | None | 0 | 1 | 1 | 1 | View |
| Cohort 5 (FIH): Emirodatamab Dose E | Emirodatamab Dose E was administered as an IV infusion in a 2-week cycle with no step dosing. Dexamethasone 8 mg IV was administered within 1 hour before dosing. | 1 | None | 3 | 5 | 5 | 5 | View |
| Cohort 6 (FIH): Emirodatamab Dose F | Emirodatamab Dose F was administered as an IV infusion in a 2-week cycle with no step dosing. Dexamethasone 8 mg IV was administered within 1 hour before dosing. | 1 | None | 4 | 4 | 4 | 4 | View |
| Cohort 7a (FIH): Emirodatamab Dose G | Emirodatamab Dose G was administered as an IV infusion in a 2-week cycle with no step dosing. Dexamethasone 8 mg IV was administered within 1 hour before dosing. | 0 | None | 2 | 2 | 2 | 2 | View |
| Cohort 7b (FIH): Emirodatamab Dose F/Dose G | Emirodatamab was administered as an IV infusion with step dosing; Dose F followed by Dose G (2-week cycle). Dexamethasone 8 mg IV was administered within 1 hour before dosing. | 2 | None | 1 | 3 | 3 | 3 | View |
| Cohort 8 (FIH): Emirodatamab Dose F/Dose H | Emirodatamab was administered as an IV infusion with step dosing; Dose F followed by Dose H (2-week cycle). Dexamethasone 8 mg IV was administered within 1 hour before dosing. | 1 | None | 1 | 4 | 4 | 4 | View |
| Cohort 9 (FIH): Emirodatamab Dose F/Dose H/Dose I | Emirodatamab was administered as an IV infusion with step dosing; Dose F followed by Doses H and I (2-week cycle). Dexamethasone 8 mg IV was administered within 1 hour before dosing. | 2 | None | 2 | 4 | 4 | 4 | View |
| Cohort 10 (FIH): Emirodatamab Dose F/Dose H/Dose J | Emirodatamab was administered as an IV infusion with step dosing; Dose F followed by Doses H and J (2-week cycle). Dexamethasone 8 mg IV was administered within 1 hour before dosing. | 1 | None | 4 | 4 | 4 | 4 | View |
| Cohort 11 (FIH): Emirodatamab Dose F/Dose H/Dose K | Emirodatamab was administered as an IV infusion with step dosing; Dose F followed by Doses H and K (2-week cycle). Dexamethasone 8 mg IV was administered within 1 hour before dosing. | 0 | None | 2 | 4 | 4 | 4 | View |
| Cohort 12 (FIH): Emirodatamab Dose F/Dose H/Dose L | Emirodatamab was administered as an IV infusion with step dosing; Dose F followed by Doses H and L (2-week cycle). Dexamethasone 8 mg IV was administered within 1 hour before dosing. | 2 | None | 5 | 7 | 7 | 7 | View |
| Cohort 13 (FIH): Emirodatamab Dose F/Dose H/Dose M | Emirodatamab was administered as an IV infusion with step dosing; Dose F followed by Doses H and M (2-week cycle). Dexamethasone 8 mg IV was administered within 1 hour before dosing. | 1 | None | 2 | 3 | 3 | 3 | View |
| Cohort 14 (eIV): Emirodatamab Dose F/Dose H/Dose J/Dose K | Emirodatamab was administered as an eIV infusion with step dosing; Dose F followed by Doses H, J, and K (2-week cycle). Dexamethasone 8 mg IV was administered within 1 hour before dosing. | 1 | None | 5 | 7 | 7 | 7 | View |
| Cohort 15 (eIV): Emirodatamab Dose F/Dose H/Dose J | Emirodatamab was administered as an eIV infusion with step dosing; Dose F followed by Doses H and J (2-week cycle). Dexamethasone 8 mg IV was administered within 1 hour before dosing. | 1 | None | 2 | 3 | 3 | 3 | View |
| Cohort 16: Etanercept + Emirodatamab Dose E | Emirodatamab Dose E was administered as an IV infusion in a 2-week cycle. Participants were administered etanercept 50 mg SC 2 days before emirodatamab dosing. Dexamethasone 8 mg IV was administered within 1 hour before emirodatamab dosing. | 0 | None | 2 | 6 | 6 | 6 | View |
| Cohort 17: Etanercept + Emirodatamab Dose F | Emirodatamab Dose F was administered as an IV infusion in a 2-week cycle. Participants were administered etanercept 50 mg SC 2 days before emirodatamab dosing. Dexamethasone 8 mg IV was administered within 1 hour before emirodatamab dosing. | 1 | None | 3 | 4 | 4 | 4 | View |
| Overall Studies | All participants included in all cohorts. | 14 | None | 40 | 64 | 64 | 64 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 26.0 | View |
| Febrile neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 26.0 | View |
| Leukocytosis | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 26.0 | View |
| Pancytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 26.0 | View |
| Splenomegaly | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 26.0 | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 26.0 | View |
| Atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 26.0 | View |
| Atrioventricular block complete | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 26.0 | View |
| Ear pain | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 26.0 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.0 | View |
| Colitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.0 | View |
| Generalised oedema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.0 | View |
| Hyperbilirubinaemia | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 26.0 | View |
| Cytokine release syndrome | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 26.0 | View |
| Haemophagocytic lymphohistiocytosis | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 26.0 | View |
| Appendicitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| Bacillus infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| Bacteraemia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| Bacterial infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| Diverticulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| Enterobacter bacteraemia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| Fungal sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| Mucormycosis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| Neutropenic infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| Periorbital cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| Pneumonia fungal | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| Post procedural cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| Puncture site cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| Septic shock | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| Sinusitis fungal | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| Staphylococcal sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| Infusion related reaction | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 26.0 | View |
| Platelet count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.0 | View |
| White blood cell count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.0 | View |
| Hypokalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 26.0 | View |
| Tumour lysis syndrome | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 26.0 | View |
| Acute myeloid leukaemia | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | View |
| Cerebral haemorrhage | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.0 | View |
| Haemorrhage intracranial | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.0 | View |
| Acute kidney injury | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 26.0 | View |
| Productive cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | View |
| Pulmonary haemorrhage | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | View |
| Respiratory distress | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | View |
| Respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | View |
| Pyoderma gangrenosum | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 26.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Dry eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 26.0 | View |
| Exophthalmos | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 26.0 | View |
| Eye irritation | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 26.0 | View |
| Eye pain | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 26.0 | View |
| Eye swelling | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 26.0 | View |
| Photophobia | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 26.0 | View |
| Retinal detachment | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 26.0 | View |
| Vision blurred | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 26.0 | View |
| Abdominal discomfort | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.0 | View |
| Abdominal distension | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.0 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.0 | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.0 | View |
| Anal fissure | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.0 | View |
| Anal incontinence | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.0 | View |
| Anorectal discomfort | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.0 | View |
| Ascites | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.0 | View |
| Colitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.0 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.0 | View |
| Dental caries | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.0 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.0 | View |
| Dry mouth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.0 | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.0 | View |
| Dysphagia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.0 | View |
| Eructation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.0 | View |
| Flatulence | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.0 | View |
| Gastrooesophageal reflux disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.0 | View |
| Gingival bleeding | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.0 | View |
| Gingival pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.0 | View |
| Glossodynia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.0 | View |
| Haemorrhoids | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.0 | View |
| Hypoaesthesia oral | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.0 | View |
| Lip pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.0 | View |
| Mouth swelling | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.0 | View |
| Mouth ulceration | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.0 | View |
| Oral mucosal erythema | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.0 | View |
| Oral pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.0 | View |
| Alpha haemolytic streptococcal infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| Bacteraemia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| Bacteroides bacteraemia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| Sinusitis fungal | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| Staphylococcal infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| Allergic transfusion reaction | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 26.0 | View |
| Hypermagnesaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 26.0 | View |
| Hypernatraemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 26.0 | View |
| Hyperphosphataemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 26.0 | View |
| Hyperuricaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 26.0 | View |
| Hypervolaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 26.0 | View |
| Hypoalbuminaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 26.0 | View |
| Hypocalcaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 26.0 | View |
| Hypokalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 26.0 | View |
| Hypomagnesaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 26.0 | View |
| Hyponatraemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 26.0 | View |
| Hypophagia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 26.0 | View |
| Hypophosphataemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 26.0 | View |
| Hypouricaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 26.0 | View |
| Malnutrition | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 26.0 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | View |
| Bone pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | View |
| Confusional state | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 26.0 | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 26.0 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 26.0 | View |
| Mental status changes | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 26.0 | View |
| Nightmare | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 26.0 | View |
| Restlessness | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 26.0 | View |
| Lethargy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.0 | View |
| Migraine | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.0 | View |
| Myoclonus | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.0 | View |
| Paraesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.0 | View |
| Peripheral sensory neuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.0 | View |
| Presyncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.0 | View |
| Tremor | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.0 | View |
| Adjustment disorder with depressed mood | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 26.0 | View |
| Agitation | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 26.0 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 26.0 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 26.0 | View |
| Lymphoedema | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 26.0 | View |
| Phlebitis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 26.0 | View |
| Thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 26.0 | View |
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 26.0 | View |
| Coagulopathy | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 26.0 | View |
| Disseminated intravascular coagulation | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 26.0 | View |
| Febrile neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 26.0 | View |
| Hypofibrinogenaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 26.0 | View |
| Increased tendency to bruise | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 26.0 | View |
| Leukocytosis | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 26.0 | View |
| Leukopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 26.0 | View |
| Lymphadenopathy | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 26.0 | View |
| Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 26.0 | View |
| Pancytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 26.0 | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 26.0 | View |
| Aortic valve disease | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 26.0 | View |
| Atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 26.0 | View |
| Cardiomyopathy | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 26.0 | View |
| Mitral valve disease | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 26.0 | View |
| Pericardial effusion | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 26.0 | View |
| Sinus bradycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 26.0 | View |
| Sinus tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 26.0 | View |
| Tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 26.0 | View |
| Tricuspid valve disease | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 26.0 | View |
| Ear discomfort | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 26.0 | View |
| Ear pain | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 26.0 | View |
| Asthenopia | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 26.0 | View |
| Pancreatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.0 | View |
| Proctalgia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.0 | View |
| Proctitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.0 | View |
| Rectal discharge | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.0 | View |
| Reflux gastritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.0 | View |
| Stomatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.0 | View |
| Tooth erosion | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.0 | View |
| Toothache | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.0 | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.0 | View |
| Axillary pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.0 | View |
| Chest discomfort | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.0 | View |
| Chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.0 | View |
| Chills | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.0 | View |
| Face oedema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.0 | View |
| Facial pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.0 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.0 | View |
| Generalised oedema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.0 | View |
| Localised oedema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.0 | View |
| Mucosal inflammation | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.0 | View |
| Non-cardiac chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.0 | View |
| Oedema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.0 | View |
| Oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.0 | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.0 | View |
| Peripheral swelling | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.0 | View |
| Physical deconditioning | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.0 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.0 | View |
| Swelling | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.0 | View |
| Swelling face | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.0 | View |
| Temperature intolerance | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.0 | View |
| Cholecystitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 26.0 | View |
| Hepatic steatosis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 26.0 | View |
| Hyperbilirubinaemia | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 26.0 | View |
| Hypertransaminasaemia | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 26.0 | View |
| Periportal oedema | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 26.0 | View |
| Cytokine release syndrome | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 26.0 | View |
| Haemophagocytic lymphohistiocytosis | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 26.0 | View |
| Seasonal allergy | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 26.0 | View |
| Bronchopulmonary aspergillosis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| COVID-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| Cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| Clostridium difficile infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| Colonic abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| Cystitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| Cystitis bacterial | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| Device related bacteraemia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| Device related infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| Enterobacter bacteraemia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| Enterococcal infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| Escherichia infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| Folliculitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| Fungal skin infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| Localised infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| Oral herpes | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| Perirectal abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| Respiratory tract infection fungal | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 26.0 | View |
| Limb injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 26.0 | View |
| Peripancreatic fluid collection | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 26.0 | View |
| Skin laceration | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 26.0 | View |
| Transfusion reaction | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 26.0 | View |
| Activated partial thromboplastin time prolonged | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.0 | View |
| Alanine aminotransferase abnormal | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.0 | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.0 | View |
| Amylase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.0 | View |
| Antithrombin III decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.0 | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.0 | View |
| Blood alkaline phosphatase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.0 | View |
| Blood bilirubin increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.0 | View |
| Blood creatinine increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.0 | View |
| Blood fibrinogen decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.0 | View |
| Blood urine present | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.0 | View |
| International normalised ratio increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.0 | View |
| Lipase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.0 | View |
| Liver function test abnormal | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.0 | View |
| Liver function test increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.0 | View |
| Lymphocyte count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.0 | View |
| Neutrophil count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.0 | View |
| Platelet count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.0 | View |
| Transaminases | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.0 | View |
| Troponin I increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.0 | View |
| Weight decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.0 | View |
| Weight increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.0 | View |
| White blood cell count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.0 | View |
| White blood cell count increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.0 | View |
| Appetite disorder | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 26.0 | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 26.0 | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 26.0 | View |
| Fluid retention | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 26.0 | View |
| Glucose tolerance impaired | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 26.0 | View |
| Hypercalcaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 26.0 | View |
| Hyperglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 26.0 | View |
| Hyperkalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 26.0 | View |
| Joint effusion | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | View |
| Joint swelling | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | View |
| Muscle spasms | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | View |
| Muscular weakness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | View |
| Musculoskeletal pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | View |
| Neck pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | View |
| Osteonecrosis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | View |
| Pain in jaw | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | View |
| Altered state of consciousness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.0 | View |
| Central nervous system lesion | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.0 | View |
| Cerebral haemorrhage | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.0 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.0 | View |
| Dysgeusia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.0 | View |
| Formication | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.0 | View |
| Hemiparesis | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.0 | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 26.0 | View |
| Acute kidney injury | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 26.0 | View |
| Dysuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 26.0 | View |
| Haematuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 26.0 | View |
| Hydronephrosis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 26.0 | View |
| Micturition urgency | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 26.0 | View |
| Pollakiuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 26.0 | View |
| Renal failure | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 26.0 | View |
| Renal impairment | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 26.0 | View |
| Urethral pain | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 26.0 | View |
| Urinary incontinence | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 26.0 | View |
| Urinary retention | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 26.0 | View |
| Female genital tract fistula | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 26.0 | View |
| Penile pain | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 26.0 | View |
| Vaginal discharge | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 26.0 | View |
| Vulvovaginal pruritus | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 26.0 | View |
| Atelectasis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | View |
| Dyspnoea exertional | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | View |
| Haemoptysis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | View |
| Hypoxia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | View |
| Laryngeal haemorrhage | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | View |
| Lung infiltration | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | View |
| Lung opacity | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | View |
| Nasal congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | View |
| Oropharyngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | View |
| Pleural effusion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | View |
| Pulmonary hilum mass | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | View |
| Pulmonary oedema | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | View |
| Respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | View |
| Rhinitis allergic | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | View |
| Sinus pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | View |
| Tachypnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | View |
| Wheezing | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | View |
| Blister | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 26.0 | View |
| Decubitus ulcer | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 26.0 | View |
| Eczema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 26.0 | View |
| Erythema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 26.0 | View |
| Intertrigo | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 26.0 | View |
| Nail bed bleeding | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 26.0 | View |
| Night sweats | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 26.0 | View |
| Pain of skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 26.0 | View |
| Petechiae | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 26.0 | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 26.0 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 26.0 | View |
| Rash erythematous | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 26.0 | View |
| Rash maculo-papular | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 26.0 | View |
| Skin exfoliation | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 26.0 | View |
| Skin irritation | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 26.0 | View |
| Skin lesion | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 26.0 | View |
| Urticaria | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 26.0 | View |
| Flushing | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 26.0 | View |
| Haematoma | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 26.0 | View |