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: 2025-12-24 @ 3:21 PM
Ignite Modification Date: 2025-12-25 @ 1:40 PM
NCT ID: NCT03604692
Description: Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
Frequency Threshold: 0
Time Frame: From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Study: NCT03604692
Study Brief: A Phase 1/2 Study to Evaluate Axatilimab in Participants With Active cGVHD
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
SNDX-6352 0.15 mg/kg Q2W Participants received an IV infusion of SNDX-6352 0.15 mg/kg Q2W in Phase 1. 0 None 1 1 1 1 View
SNDX-6352 0.5 mg/kg Q2W Participants received an IV infusion of SNDX-6352 0.5 mg/kg Q2W in Phase 1. 0 None 1 1 1 1 View
SNDX-6352 1 mg/kg Q2W Participants received an IV infusion of SNDX-6352 1 mg/kg Q2W in Phases 1 and 2. 1 None 12 26 26 26 View
SNDX-6352 3 mg/kg Q2W Participants received an IV infusion of SNDX-6352 3 mg/kg Q2W in Phase 1. 0 None 3 6 6 6 View
SNDX-6352 3 mg/kg Q4W Participants received an IV infusion of SNDX-6352 3 mg/kg Q4W in Phase 1. 0 None 2 6 6 6 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.0 View
Bronchiectasis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Chronic obstructive pulmonary disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.0 View
Diverticulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Face oedema SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Gastroenteritis norovirus SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Hepatitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 24.0 View
Hip fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
Hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 24.0 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.0 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24.0 View
Hypovolaemic shock SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24.0 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Ischaemic cerebral infarction SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Klebsiella infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Leukocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24.0 View
Lymphoedema SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24.0 View
Mental status changes SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.0 View
Metapneumovirus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Multiple injuries SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
Muscular weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Osteonecrosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
Pain of skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.0 View
Parainfluenzae virus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Peripheral ischaemia SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24.0 View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Pneumonia bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Septic arthritis staphylococcal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Septic shock SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Spinal fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
Squamous cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.0 View
Thrombophlebitis superficial SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Wound infection pseudomonas SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Serratia sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Cholecystitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 24.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Eye infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Fungal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Cataract SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 24.0 View
Conjunctival haemorrhage SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 24.0 View
Eye irritation SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 24.0 View
Lacrimation increased SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 24.0 View
Photophobia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 24.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24.0 View
Haematoma SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24.0 View
Flushing SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24.0 View
Haemorrhage SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24.0 View
Hot flush SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24.0 View
Dysuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Malaise SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Gait disturbance SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Influenza like illness SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Oedema SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Axillary pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Chest discomfort SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Feeling abnormal SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Injection site reaction SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Swelling face SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Blood creatine phosphokinase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Blood lactate dehydrogenase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Amylase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Lipase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Gamma-glutamyltransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Blood alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Blood cholesterol increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
White blood cell count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Blood creatine phosphokinase abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Blood thyroid stimulating hormone increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
C-reactive protein SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Red blood cell sedimentation rate increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Vitamin B1 decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Hypophosphataemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.0 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.0 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.0 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.0 View
Hyperkalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.0 View
Hypomagnesaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.0 View
Hyperuricaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.0 View
Hypoalbuminaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.0 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.0 View
Hypocalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.0 View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.0 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.0 View
Fluid retention SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.0 View
Hyperammonaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.0 View
Hypercalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.0 View
Hypophagia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.0 View
Lactic acidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Abdominal discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Abdominal pain lower SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Faeces discoloured SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Gastrooesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Haemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Oral disorder SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Oral pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Tongue erythema SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Conjunctivitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Pustule SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Diverticulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Klebsiella infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Oesophageal candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Otitis externa SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Paronychia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Pseudomonas infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Rhinovirus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Skin infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Wound infection pseudomonas SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
Muscle spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
Muscular weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
Abscess neck SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
Intervertebral disc degeneration SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
Myositis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
Pain in jaw SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
Rotator cuff syndrome SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Dyspnoea exertional SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Productive cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Rhinorrhoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Hiccups SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Paranasal sinus discomfort SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Rhinitis allergic SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Wheezing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Periorbital oedema SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 24.0 View
Vision blurred SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 24.0 View
Diplopia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 24.0 View
Eye pain SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 24.0 View
Neuropathy peripheral SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Hypoaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Disturbance in attention SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Memory impairment SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.0 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.0 View
Agitation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.0 View
Confusional state SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.0 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.0 View
Hallucination SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.0 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.0 View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.0 View
Hyperhidrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.0 View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.0 View
Skin lesion SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.0 View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.0 View
Ingrowing nail SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.0 View
Night sweats SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.0 View
Skin ulcer SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.0 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24.0 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24.0 View
Splenomegaly SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24.0 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24.0 View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
Infusion related reaction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
Back injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
Hand fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
Procedural headache SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
Skin abrasion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
Upper limb fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
Vascular access complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
Wound complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.0 View
Chromaturia SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.0 View
Incontinence SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.0 View
Nocturia SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.0 View
Urethral prolapse SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.0 View
Supraventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.0 View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.0 View
Adrenal insufficiency SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 24.0 View
Androgen deficiency SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 24.0 View
Vaginal haemorrhage SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 24.0 View
Vulvovaginal dryness SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 24.0 View
Ear pain SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 24.0 View
Basal cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.0 View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Varicose vein SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24.0 View