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: 2025-12-26 @ 4:01 PM
Ignite Modification Date: 2025-12-26 @ 4:01 PM
NCT ID: NCT02054806
Description: ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
Frequency Threshold: 5
Time Frame: Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
Study: NCT02054806
Study Brief: Study of Pembrolizumab (MK-3475) in Participants With Advanced Solid Tumors (MK-3475-028/KEYNOTE-28)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
First Course Pembrolizumab 10 mg/kg Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. 426 None 160 475 429 475 View
Second Course Pembrolizumab 10 mg/kg Qualified participants who completed the first course of pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years, but experienced disease progression, initiated a second course of pembrolizumab at the investigator's discretion, at 10 mg/kg IV Q2W for up to \~1 year. 6 None 3 11 10 11 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24.0 View
Autoimmune haemolytic anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24.0 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24.0 View
Acute coronary syndrome SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.0 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.0 View
Atrial tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.0 View
Atrioventricular block complete SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.0 View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.0 View
Pericardial effusion SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.0 View
Pulseless electrical activity SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.0 View
Ear haemorrhage SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 24.0 View
Hypercalcaemia of malignancy SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 24.0 View
Hypothyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 24.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Ascites SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Enteritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Enterocolitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Gastrointestinal ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Haemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Ileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Intestinal ischaemia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Large intestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Malignant gastrointestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Melaena SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Small intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Subileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Upper gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Complication associated with device SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Death SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
General physical health deterioration SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Influenza like illness SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Malaise SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Oedema SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Acute hepatic failure SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 24.0 View
Autoimmune hepatitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 24.0 View
Biliary colic SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 24.0 View
Biliary obstruction SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 24.0 View
Cholangitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 24.0 View
Cholestasis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 24.0 View
Hepatic cytolysis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 24.0 View
Hepatic failure SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 24.0 View
Hepatitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 24.0 View
Hyperbilirubinaemia SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 24.0 View
Jaundice SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 24.0 View
Liver disorder SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 24.0 View
Cytokine release syndrome SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 24.0 View
Abdominal sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Biliary sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Clostridium difficile colitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Device related bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Device related infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Device related sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Escherichia sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Gastroenteritis viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Helicobacter infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Infectious mononucleosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Infectious pleural effusion SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Liver abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Lower respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Lower respiratory tract infection bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Meningitis bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Oropharyngeal candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Osteomyelitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Otitis media SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Pelvic abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Peritonitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Pulmonary sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Salmonellosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Septic shock SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Streptococcal sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Subcutaneous abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Wound infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Femoral neck fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
Gastroenteritis radiation SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
Post procedural complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations 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
Transaminases increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.0 View
Food intolerance SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.0 View
Hypercalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.0 View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.0 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.0 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.0 View
Hypovolaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.0 View
Type 2 diabetes mellitus SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
Arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
Flank pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
Joint effusion SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
Rhabdomyolysis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
Cancer pain SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.0 View
Malignant melanoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.0 View
Myelodysplastic syndrome SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.0 View
Squamous cell carcinoma of skin SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.0 View
Tumour associated fever SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.0 View
Tumour compression SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.0 View
Tumour pain SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.0 View
Altered state of consciousness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Epilepsy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Guillain-Barre syndrome SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Hydrocephalus SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Ischaemic stroke SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Migraine SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Myelitis transverse SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Neuropathy peripheral SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Device occlusion SYSTEMATIC_ASSESSMENT Product Issues MedDRA 24.0 View
Anxiety 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
Mental status changes SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.0 View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.0 View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.0 View
Hydronephrosis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.0 View
Renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.0 View
Ureteric dilatation SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.0 View
Urinary retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.0 View
Intermenstrual bleeding SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 24.0 View
Vaginal haemorrhage SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 24.0 View
Vulvovaginal pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 24.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Haemoptysis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Interstitial lung disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Noninfective bronchitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Pneumonia aspiration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Respiratory distress SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Tracheal stenosis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Acute febrile neutrophilic dermatosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.0 View
Dermatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.0 View
Pemphigoid SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.0 View
Haemorrhage SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24.0 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24.0 View
Lymphoedema SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24.0 View
Lymphorrhoea SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24.0 View
Orthostatic hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24.0 View
Thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24.0 View
Hypothyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 24.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Asthenia SYSTEMATIC_ASSESSMENT General 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
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Blood alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Decreased appetite 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
Hypomagnesaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.0 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition 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
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue 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
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric 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
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.0 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.0 View
Rash 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
Iron deficiency anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24.0 View
Hypoacusis SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 24.0 View
Oral pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Blood lactate dehydrogenase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Hepatic enzyme increased SYSTEMATIC_ASSESSMENT Investigations 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
Arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
Musculoskeletal chest pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
Memory impairment SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Hematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.0 View
Vulvovaginal dryness SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 24.0 View
Dysphonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Dermatitis acneiform SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.0 View
Palmar-plantar erythrodysaesthesia syndrome SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.0 View
Rash pruritic SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.0 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24.0 View
Lumbar vertebral fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
Conjunctivitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Gingivitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Lower respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Oral candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Abdominal pain lower SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Influenza like illness SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Mucosal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Viral upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Intertrigo SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.0 View
Skin discolouration SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.0 View
Jugular vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24.0 View
Cataract SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 24.0 View
Dry eye SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 24.0 View
Uveitis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 24.0 View