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 @ 2:17 PM
Ignite Modification Date: 2025-12-25 @ 12:54 PM
NCT ID: NCT00427895
Description: SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
Frequency Threshold: 0
Time Frame: Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
Study: NCT00427895
Study Brief: Study Comparing a 13-valent Pneumococcal Conjugate Vaccine With 23-valent Pneumococcal Polysaccharide Vaccine in Adults
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, Cohort 1 Participants aged 60-64 years old received 13 valent pneumococcal conjugate (13vPnC) administered as a single dose 0.5 mL (Vaccination 1 \[Vax1\]), reported after vaccination. None None 1 417 277 417 View
13vPnC: 6 Month Follow-up After Vax 1, Cohort 1 Participants aged 60-64 years old received 13 valent pneumococcal conjugate (13vPnC) administered as a single dose 0.5 mL (Vaccination 1), reported at 6-month follow-up. None None 12 417 0 417 View
23vPS: 6 Month Follow-up After Vax 1, Cohort 1 Participants aged 60-64 years old received 23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a single dose 0.5 mL (Vaccination 1), reported at 6-month follow-up. None None 10 414 5 414 View
13vPnC, Cohort 2 Participants aged 50-59 years old received 13vPnC administered as a single dose 0.5 mL (Vaccination 1), reported after vaccination 1. Out of 404 participants vaccinated, 1 participant randomized and vaccinated in error without a consent form, and hence safety data is available for 403 participant. None None 2 403 293 403 View
13vPnC: 6 Month Follow-up After Vax 1, Cohort 2 Participants aged 50-59 years old received 13vPnC administered as a single dose 0.5 mL (Vaccination 1), reported at 6-month follow-up. Out of 404 participants vaccinated, 1 participant randomized and vaccinated in error without a consent form, and hence safety data is available for 403 participant. None None 5 403 2 403 View
13vPnC/13vPnC, Cohort 1 Participants aged 60-64 years old who received 13vPnC at vaccination 1 received a 0.5 mL single dose of open-label 13vPnC at Year 3 to 4 (Vaccination 2), reported after vaccination 2. None None 1 108 66 108 View
13vPnC/13vPnC: 6 Month Follow-up After Vax 2, Cohort 1 Participants aged 60-64 years old who received 13vPnC at vaccination 1 received a 0.5 mL single dose of open-label 13vPnC at Year 3 to 4 (Vaccination 2), reported at 6-month follow-up after vaccination 2. None None 2 108 1 108 View
13vPnC/23vPS, Cohort 1 Participants aged 60-64 years old who received 13vPnC at vaccination 1 received a 0.5 mL single dose of open-label 23vPS at Year 3 to 4 (Vaccination 2), reported after vaccination 2. None None 1 108 73 108 View
23vPS/23vPS, Cohort 1 Participants aged 60-64 years old who received 23vPS at vaccination 1 received a 0.5 mL single dose of open-label 23vPS at Year 3 to 4 (Vaccination 2), reported after vaccination 2. None None 0 189 143 189 View
23vPS/23vPS: 6 Month Follow-up After Vax 2, Cohort 1 Participants aged 60-64 years old who received 23vPS at vaccination 1 received a 0.5 mL single dose of open-label 23vPS at Year 3 to 4 (Vaccination 2), reported at 6-month follow-up after vaccination 2. None None 3 189 13 189 View
13vPnC/13vPnC, Cohort 2 Participants aged 50-59 years old who received 13vPnC at vaccination 1 received a 0.5 mL single dose of open-label 13vPnC at Year 3 to 4 (Vaccination 2), reported after vaccination 2. None None 0 214 164 214 View
13vPnC/13vPnC: 6 Month Follow-up After Vax 2, Cohort 2 Participants aged 50-59 years old who received 13vPnC at vaccination 1 received a 0.5 mL single dose of open-label 13vPnC at Year 3 to 4 (Vaccination 2), reported at 6-month follow-up after vaccination 2. None None 0 214 4 214 View
13vPnC, Cohort 3 Participants aged 18-49 years old received 13vPnC administered as a single dose 0.5 mL (Vaccination 1), reported after vaccination 1. None None 2 899 779 899 View
23vPS, Cohort 1 Participants aged 60-64 years old received 23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a single dose 0.5 mL (Vaccination 1), reported after vaccination 1. None None 2 414 271 414 View
13vPnC/23vPS: 6 Month Follow-up After Vax 2, Cohort 1 Participants aged 60-64 years old who received 13vPnC at vaccination 1 received a 0.5 mL single dose of open-label 23vPS at Year 3 to 4 (Vaccination 2), reported at 6-month follow-up after vaccination 2. None None 1 108 4 108 View
13vPnC: 6 Month Follow-up After Vax 1, Cohort 3 Participants aged 18-49 years old received 13vPnC administered as a single dose 0.5 mL (Vaccination 1), reported at 6-month follow-up. None None 2 899 1 899 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Myocardial infarction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Cellulitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Procedural pain NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Haemangioma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Malignant melanoma 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
Ligament rupture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Erythema multiforme NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Coronary artery disease NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Lumbar vertebral fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Rib fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Osteoarthritis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Endometrial cancer metastatic NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Nystagmus NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Angina pectoris NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Abdominal mass NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Crohn's disease NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Gastrooesophageal reflux NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Rectal haemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Non-cardiac chest pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Bile duct obstruction NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
Cholecystitis NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
Cholecystitis acute NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
Cholelithiasis NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
Pneumonia bacterial NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Intervertebral disc protrusion NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Spinal column stenosis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Prostate cancer NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Breast cancer NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Hepatic neoplasm malignant NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Pancreatic carcinoma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Bipolar disorder NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Suicidal ideation NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Thrombosis NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Pancreatitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Bronchitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Femur fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Meningioma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Chronic obstructive pulmonary disease NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Lymphadenectomy NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA View
Basal cell carcinoma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Migraine NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Hip fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Ovarian cyst ruptured NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Pharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pharyngitis streptococcal NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Staphylococcal infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Vaginal infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Viral upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Acarodermatitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Fungal infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Gastroenteritis viral NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Clostridial infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Diverticulitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Hordeolum NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pyelonephritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Skin candida NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Tooth abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Tinea infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Arthropod bite NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Skin laceration NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Lower limb fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Rib fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Arthropod sting NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Skin injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Tendon rupture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Muscle strain NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Contusion NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Fall NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Ligament rupture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Ligament sprain NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Upper limb fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Prostatic specific antigen increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Weight decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Gout NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Myalgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Pain in extremity NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Musculoskeletal pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Musculoskeletal stiffness NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Arthritis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Musculoskeletal chest pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Neck pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Pain in jaw NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Rotator cuff syndrome NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Muscle spasms NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Tenosynovitis 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
Melanocytic naevus NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Hypoaesthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Sciatica NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Paraesthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Somnolence NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Neuralgia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Anxiety NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Depressive symptom NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Nephrolithiasis NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Renal failure NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Testicular pain NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Vaginal discharge NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Nipple exudate bloody NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Rhinorrhoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Oropharyngeal pain NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Nasal congestion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Asthma NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Diaphragmalgia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Paranasal sinus hypersecretion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Sneezing NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Dyspnoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Pulmonary congestion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Rhinitis allergic NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Sinus congestion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Upper-airway cough syndrome NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Dermatitis contact NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue 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
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Acne NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Dermatitis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Petechiae NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Precancerous skin lesion NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Swelling face NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Urticaria NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Erythema multiforme NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Haematoma NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Hot flush NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
hypotension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Hyperlipidaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Fever Any (>=38 degrees C) SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Fever Mild (>=38 degrees C but <38.5 degrees C) SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Fever Moderate (>=38.5 degrees C but <39 degrees C) SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Fever Severe (>=39 degrees C but <=40 degrees C) SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Fever Potentially life threatening (>40 degrees C) SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Iron deficiency anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Lymph node pain NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Cerumen impaction NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
Lacrimation increased NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Abdominal pain upper NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Injection site warmth NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Injection site irritation NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Injection site induration NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Allergy to vaccine NON_SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA View
Drug hypersensitivity NON_SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA View
Viral infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Vulvovaginal mycotic infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Limb injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Heart rate increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Hyperglycaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Polydipsia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Medial tibial stress syndrome NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Muscle twitching NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Nerve compression NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Neuritis NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Tension headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Mood altered NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Nephrolithiasis NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Bronchial hyperreactivity NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Epistaxis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Upper respiratory tract congestion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Dermatitis allergic NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Skin irritation NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Laceration NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Hand fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Procedural pain NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Bipolar disorder NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Decreased appetite NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Limitation of arm movement (Severe) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reactions View
Fatigue SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Headache SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Chills SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Rash SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Vomiting SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Decreased appetite SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
New generalized muscle pain SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Aggravated generalized muscle pain SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
New generalized joint pain SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Aggravated generalized joint pain SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Lymphadenitis NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Leukocytosis NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Deafness bilateral NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
Cataract NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Visual impairment NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Hypothyroidism NON_SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Non-cardiac chest pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Oedema peripheral NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Diverticulum NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Gastrooesophageal reflux disease NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Head injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Procedural dizziness NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Joint injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Herpes simplex NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Tendonitis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Joint stiffness NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Muscle tightness NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Hypercholesterolaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hypokalaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Aphonia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Dementia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Generalised anxiety disorder NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Renal failure chronic NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Breast mass NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Atrophic vulvovaginitis NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Rosacea NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Rash pruritic NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Venous insufficiency NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Lymphadenopathy NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Ear congestion NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
Ear discomfort NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
Vertigo NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
Ear pain NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
Eye irritation NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Eye pruritus NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Vision blurred NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Dyspepsia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Abdominal discomfort NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Chapped lips NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Abdominal pain lower NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Toothache NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Haemorrhoids NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Inguinal hernia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Colonic polyp NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Gastritis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Injection site pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Injection site pruritus NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Adverse drug reaction NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Injection site injury NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Injury associated with device NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Malaise NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Mass NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Injection site reaction NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Vessel puncture site haematoma NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Injection site rash NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Injection site swelling NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Sinusitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations 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) 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
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
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
Axillary pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Chills NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Influenza like illness NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Injection site haematoma NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Injection site erythema NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Injection site pallor NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Seasonal allergy NON_SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Gastroenteritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Bronchitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Lower respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Localised infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Oral herpes NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Bacterial infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Cellulitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Gingival infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Herpes zoster NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Influenza NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Laryngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Otitis media NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View