Adverse Events Module

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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 @ 4:05 AM
Ignite Modification Date: 2025-12-26 @ 3:01 AM
NCT ID: NCT05168202
Description: The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Frequency Threshold: 5
Time Frame: Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
Study: NCT05168202
Study Brief: A Study to Assess the Effect of CC-95251 in Participants With Acute Myeloid Leukemia and Myelodysplastic Syndromes
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Part A: Treatment 1 Monotherapy : CC-95251 20mg/kg 6 None 6 6 6 6 View
Part A: Treatment 2 Monotherapy : CC-95251 30mg/kg 7 None 7 8 8 8 View
Part A: Treatment 3 Combination : CC-95251 10mg/kg + Azacitidine 75 mg/m2 6 None 8 9 7 9 View
Part A: Treatment 4 Combination : CC-95251 20mg/kg + Azacitidine 75 mg/m2 9 None 7 10 9 10 View
Part A: Treatment 5 Combination : CC-95251 30mg/kg + Azacitidine 75 mg/m2 6 None 7 8 7 8 View
Part A: Treatment 6 Triplet Combination : CC-95251 20mg/kg + Azacitidine 75 mg/m2 + Venetoclax 8 None 10 10 10 10 View
Part A: Treatment 7 Triplet Combination : CC-95251 30mg/kg + Azacitidine 75 mg/m2 + Venetoclax 3 None 5 5 5 5 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Disseminated intravascular coagulation SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 27.0 View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 27.0 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 27.0 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 27.0 View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Ileus paralytic SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Disease progression SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.0 View
General physical health deterioration SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.0 View
Generalised oedema SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.0 View
Multiple organ dysfunction syndrome SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.0 View
Haemophagocytic lymphohistiocytosis SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 27.0 View
Anal abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
COVID-19 pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Clostridium difficile colitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Clostridium difficile infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Device related infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Diverticulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Escherichia sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Fungal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Liver abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Localised infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Meningitis viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Neutropenic sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Pneumonia fungal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Pseudomonal bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Puncture site abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Septic shock SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Sialoadenitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Streptococcal sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Vascular device infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.0 View
Femur fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.0 View
Hip fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.0 View
Infusion related reaction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.0 View
Subdural haematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.0 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
Blood alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
Gamma-glutamyltransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
General physical condition abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.0 View
Hyperkalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.0 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.0 View
Acute myeloid leukaemia SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 27.0 View
Chloroma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 27.0 View
Leukaemia SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 27.0 View
Malignant neoplasm progression SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 27.0 View
Neoplasm progression SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 27.0 View
Cerebellar haemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.0 View
Cerebral haemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.0 View
Cerebrovascular accident SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.0 View
Meningorrhagia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.0 View
Subarachnoid haemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.0 View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 27.0 View
Bronchospasm SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.0 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.0 View
Lung disorder SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.0 View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.0 View
Nail bed bleeding SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27.0 View
Rash morbilliform SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27.0 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 27.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Gastrooesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Gingival bleeding SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Haemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Lower gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Melaena SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Mouth ulceration SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Odynophagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Oral mucosa haematoma SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Oral pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Rectal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Tongue discolouration SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Tongue ulceration SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Toothache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Adverse drug reaction SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.0 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.0 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.0 View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.0 View
Face oedema SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.0 View
Generalised oedema SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.0 View
Hypothermia SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.0 View
Influenza like illness SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.0 View
Injection site erythema SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.0 View
Injection site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.0 View
Injection site reaction SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.0 View
Medical device site thrombosis SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.0 View
Mucosal inflammation SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.0 View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.0 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.0 View
Cholestasis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 27.0 View
Hepatic pain SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 27.0 View
Hypertransaminasaemia SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 27.0 View
Jaundice SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 27.0 View
Cytokine release syndrome SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 27.0 View
Bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Bacterial infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Bronchopulmonary aspergillosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Candida infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Clostridium difficile infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Conjunctivitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Cystitis escherichia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Device related infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Enterococcal bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Enterocolitis infectious SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Escherichia bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Escherichia infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Escherichia urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Eye infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Folliculitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Fungal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Oral candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Oral fungal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Oral infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Oropharyngeal candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Otitis media SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Proteus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Respiratory moniliasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Rhinovirus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Skin infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Streptococcal bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Tooth infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Vascular access site infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Vulvovaginal mycotic infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.0 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.0 View
Humerus fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.0 View
Infusion related reaction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.0 View
Periorbital haematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.0 View
Post procedural haemorrhage SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.0 View
Transfusion reaction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.0 View
Vascular access site haemorrhage SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.0 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
Blood alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
Blood lactate dehydrogenase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
C-reactive protein increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
Gamma-glutamyltransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
General physical condition abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
Hepatic enzyme increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
International normalised ratio increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
White blood cell count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.0 View
Fluid imbalance SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.0 View
Folate deficiency SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.0 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.0 View
Hyperkalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.0 View
Hyperuricaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.0 View
Hypervolaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.0 View
Hypocalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.0 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.0 View
Hypomagnesaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.0 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.0 View
Hypophosphataemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.0 View
Type 2 diabetes mellitus SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27.0 View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27.0 View
Chest wall haematoma SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27.0 View
Joint swelling SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27.0 View
Muscular weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27.0 View
Musculoskeletal chest pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27.0 View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27.0 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27.0 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27.0 View
Rotator cuff syndrome SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27.0 View
Spinal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27.0 View
Adrenal neoplasm SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 27.0 View
Chloroma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 27.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.0 View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.0 View
Loss of consciousness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.0 View
Sciatica SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.0 View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.0 View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.0 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.0 View
Taste disorder SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.0 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 27.0 View
Confusional state SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 27.0 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 27.0 View
Initial insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 27.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 27.0 View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 27.0 View
Dysuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 27.0 View
Urinary incontinence SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 27.0 View
Urinary retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 27.0 View
Bronchospasm SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.0 View
Dyspnoea exertional SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.0 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.0 View
Haemoptysis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.0 View
Lung disorder SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.0 View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.0 View
Nasal ulcer SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.0 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.0 View
Pulmonary mass SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.0 View
Pulmonary oedema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.0 View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27.0 View
Blister SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27.0 View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27.0 View
Intertrigo SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27.0 View
Pain of skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27.0 View
Palmar erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27.0 View
Petechiae SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27.0 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27.0 View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27.0 View
Skin lesion SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27.0 View
Urticaria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27.0 View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 27.0 View
Flushing SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 27.0 View
Haematoma SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 27.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 27.0 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 27.0 View
Phlebitis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 27.0 View
Thrombophlebitis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 27.0 View
Sinus bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 27.0 View
Sinus tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 27.0 View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 27.0 View
Eye irritation SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 27.0 View
Vision blurred SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 27.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 27.0 View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 27.0 View
Leukocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 27.0 View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 27.0 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 27.0 View
Pancytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 27.0 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 27.0 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 27.0 View
Eye pain SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 27.0 View