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 @ 4:30 PM
Ignite Modification Date: 2025-12-25 @ 2:23 PM
NCT ID: NCT00500266
Description: Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.
Frequency Threshold: 0
Time Frame: Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3.
Study: NCT00500266
Study Brief: Study Evaluating Safety of 13-Valent Pneumococcal Conjugate Vaccine in Healthy Elderly Subjects
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
13vPnC: Visit 1 to Visit 2 Participants received a single 0.5 mL dose of 13vPnC into the deltoid muscle of the arm once during the study. Local reactions and systemic events were collected from Day 1 through Day 14. AEs were recorded from Visit 1 to Visit 2 (29-43 days after Visit 1). SAEs were collected throughout the study. None None 10 1049 486 1049 View
13vPnC: 6-month Follow-up Participants received a single 0.5 mL dose of 13vPnC into the deltoid muscle of the arm once during the study. At visit 3, the 6-month follow-up (166-194 days after Visit 1) only newly diagnosed chronic medical conditions were collected as AEs. SAEs were collected throughout the study. None None 41 1049 77 1049 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pulmonary oedema NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Percutaneous coronary intervention NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA View
Deep vein thrombosis NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Bradyarrhythmia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Tachyarrhythmia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Gastritis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Small intestinal obstruction NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Appendicitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Hip fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Basal cell carcinoma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Loss of consciousness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Skin burning sensation NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Peripheral arterial occlusive disease NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Myocardial infarction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Atrial fibrillation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Acute coronary syndrome NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Cardiac arrest NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Cardiac failure NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Cardiac failure congestive NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Coronary artery disease NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Ischaemic cardiomyopathy NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Abscess limb NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Bacteraemia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Bronchitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Cellulitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Enteritis infectious NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Lower respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Septic shock NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Fall NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Fracture displacement NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Postoperative renal failure NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Rib fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Wrist fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Diabetic ketoacidosis NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hyperkalaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hypovolaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Osteoarthritis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Breast cancer NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Bladder cancer NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Breast cancer in situ NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Colon cancer NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Fibrosarcoma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Lung neoplasm malignant NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Metastases to lymph nodes NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Metastatic neoplasm NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Non-small cell lung cancer NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Ovarian cancer NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Renal cancer NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Renal neoplasm NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Carotid artery stenosis NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Cerebral infarction NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Cerebrovascular accident NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Guillain-Barre syndrome NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Transient ischaemic attack NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Hallucination NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Mental status changes NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Renal failure NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Renal failure acute NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Chronic obstructive pulmonary disease NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Respiratory failure NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Dyspnoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Pleural effusion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Aggravated generalized muscle pain (mild) SYSTEMATIC_ASSESSMENT General disorders Systemic events View
Injection site pruritus NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Injection site swelling NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Aggravated generalized muscle pain (moderate) SYSTEMATIC_ASSESSMENT General disorders Systemic events View
Oedema peripheral NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Aggravated generalized muscle pain (severe) SYSTEMATIC_ASSESSMENT General disorders Systemic events View
Pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Abdominal discomfort NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Redness (any) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local reactions View
Redness (mild) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local reactions View
Redness (moderate) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local reactions View
Redness (severe) NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local reactions View
Swelling (any) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local reactions View
Swelling (mild) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local reactions View
Haemorrhoidal haemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Swelling (moderate) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local reactions View
Swelling (severe) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local reactions View
Pain (any) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local reactions View
Pain (mild) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local reactions View
Pain (moderate) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local reactions View
Pain (severe) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local reactions View
Retching NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Limitation of arm movement (any) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local reactions View
Limitation of arm movement (mild) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local reactions View
Limitation of arm movement (moderate) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local reactions View
Limitation of arm movement (severe) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local reactions View
Fever (any) SYSTEMATIC_ASSESSMENT General disorders Systemic events View
Fever (mild) SYSTEMATIC_ASSESSMENT General disorders Systemic events View
Fever (moderate) SYSTEMATIC_ASSESSMENT General disorders Systemic events View
Fever (severe) SYSTEMATIC_ASSESSMENT General disorders Systemic events View
Fever (potentially life threatening) SYSTEMATIC_ASSESSMENT General disorders Systemic events View
Fatigue (any) SYSTEMATIC_ASSESSMENT General disorders Systemic events View
Fatigue (mild) SYSTEMATIC_ASSESSMENT General disorders Systemic events View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Fatigue (moderate) SYSTEMATIC_ASSESSMENT General disorders Systemic events View
Fatigue (severe) SYSTEMATIC_ASSESSMENT General disorders Systemic events View
Headache (any) SYSTEMATIC_ASSESSMENT General disorders Systemic events View
Headache (mild) SYSTEMATIC_ASSESSMENT General disorders Systemic events View
Headache (moderate) SYSTEMATIC_ASSESSMENT General disorders Systemic events View
Injection site pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Headache (severe) SYSTEMATIC_ASSESSMENT General disorders Systemic events View
Chills SYSTEMATIC_ASSESSMENT General disorders Systemic events View
Rash SYSTEMATIC_ASSESSMENT General disorders Systemic events View
Vomiting (any) SYSTEMATIC_ASSESSMENT General disorders Systemic events View
Vomiting (mild) SYSTEMATIC_ASSESSMENT General disorders Systemic events View
Vomiting (moderate) SYSTEMATIC_ASSESSMENT General disorders Systemic events View
Vomiting (severe) SYSTEMATIC_ASSESSMENT General disorders Systemic events View
Decreased appetite SYSTEMATIC_ASSESSMENT General disorders Systemic events View
Diarrhea (any) SYSTEMATIC_ASSESSMENT General disorders Systemic events View
Diarrhea (mild) SYSTEMATIC_ASSESSMENT General disorders Systemic events View
Diarrhea (moderate) SYSTEMATIC_ASSESSMENT General disorders Systemic events View
Diarrhea (severe) SYSTEMATIC_ASSESSMENT General disorders Systemic events View
New generalized muscle pain (any) SYSTEMATIC_ASSESSMENT General disorders Systemic events View
New generalized muscle pain (mild) SYSTEMATIC_ASSESSMENT General disorders Systemic events View
New generalized muscle pain (moderate) SYSTEMATIC_ASSESSMENT General disorders Systemic events View
New generalized muscle pain (severe) SYSTEMATIC_ASSESSMENT General disorders Systemic events View
Aggravated generalized muscle pain (any) SYSTEMATIC_ASSESSMENT General disorders Systemic events View
Injection site haematoma NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Stress NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Suicidal ideation NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Bladder spasm NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Renal failure NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Temporal arteritis NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
New generalized joint pain (any) SYSTEMATIC_ASSESSMENT General disorders Systemic events View
New generalized joint pain (mild) SYSTEMATIC_ASSESSMENT General disorders Systemic events View
New generalized joint pain (moderate) SYSTEMATIC_ASSESSMENT General disorders Systemic events View
New generalized joint pain (severe) SYSTEMATIC_ASSESSMENT General disorders Systemic events View
Aggravated generalized joint pain (any) SYSTEMATIC_ASSESSMENT General disorders Systemic events View
Aggravated generalized joint pain (mild) SYSTEMATIC_ASSESSMENT General disorders Systemic events View
Aggravated generalized joint pain (moderate) SYSTEMATIC_ASSESSMENT General disorders Systemic events View
Aggravated generalized joint pain (severe) SYSTEMATIC_ASSESSMENT General disorders Systemic events View
Bradycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Vertigo NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
Blepharitis NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Conjunctivitis NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Diabetic retinopathy NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Seasonal allergy NON_SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA View
Bronchitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Sinusitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Gastroenteritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Gastroenteritis viral NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Herpes zoster NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Acute sinusitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Cellulitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Ear infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Eye infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Laryngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Localised infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Nail infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Staphylococcal skin infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Tinea cruris NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Viral infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Skin laceration NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Contusion NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Limb injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Electric shock NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Excoriation NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Fall NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Joint sprain NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Blood glucose increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Dehydration NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Myalgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Musculoskeletal pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Pain in extremity NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Spinal osteoarthritis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Bone pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Bursitis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Musculoskeletal chest pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Musculoskeletal discomfort NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Neck pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Osteoarthritis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Osteoporosis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Plantar fasciitis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Rotator cuff syndrome NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Benign breast neoplasm NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Endobronchial lipoma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Lung neoplasm NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Paraesthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Carotid artery stenosis NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Carpal tunnel syndrome NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Hypoaesthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Polyneuropathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Tremor NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Bipolar disorder NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Oropharyngeal pain NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Pleural effusion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Asthma NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Nasal congestion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Pulmonary fibrosis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Respiratory disorder NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Rhinitis allergic NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Rhinorrhoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Sinus congestion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Upper respiratory tract congestion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Actinic keratosis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Dermatitis allergic NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Intertrigo NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Rash pruritic NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Skin discolouration NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Skin lesion NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Skin mass NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Hypotension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Iron deficiency anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Leukocytosis NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Angina unstable NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Aortic valve incompetence NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Arteriosclerosis coronary artery NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Coronary artery disease NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Left ventricular hypertrophy NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Tricuspid valve incompetence NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Deafness neurosensory NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
Cataract NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Gastrooesophageal reflux disease NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Diverticulum NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Haemorrhoids NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Suprapubic pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Cholelithiasis NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
Oral herpes NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Facial bones fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Incisional hernia NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Joint injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Procedural pain NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Blood thyroid stimulating hormone increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Cardiac murmur NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Glucose tolerance impaired NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hyperlipidaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Type 2 diabetes mellitus NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Osteopenia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Tendonitis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Joint range of motion decreased NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Lumbar spinal stenosis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Sacroiliitis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Meningioma benign NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Narcolepsy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Restless legs syndrome NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Haematuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Hypertonic bladder NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Renal mass NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Atrophic vulvovaginitis NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Benign prostatic hyperplasia NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Erectile dysfunction NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Chronic obstructive pulmonary disease NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Dyspnoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Emphysema NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Sleep apnoea syndrome NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Eczema NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Erythema NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Milia NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Joint prosthesis user NON_SYSTEMATIC_ASSESSMENT Social circumstances MedDRA View
Peripheral arterial occlusive disease NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Peripheral vascular disorder NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View