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 @ 6:46 PM
Ignite Modification Date: 2025-12-25 @ 4:18 PM
NCT ID: NCT00500357
Description: An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Frequency Threshold: 0
Time Frame: Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
Study: NCT00500357
Study Brief: Study Evaluating a 13-valent Pneumococcal Conjugate Vaccine in 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+AlPO4 (After Vax 1 Core Study) Administered 13vPnC+AlPO4 0.5 mL IM at Year 0 (Vax 1) in core study/NCT00269672 (6115A1-500). Events reported Day 1 up to Day 29 postvaccination. None None 2 308 70 308 View
23vPS (After Vax 1 Core Study) Administered 23vPS 0.5 mL IM at Year 0 (Vax 1) in core study/NCT00269672 (6115A1-500). Events reported Day 1 up to Day 29 postvaccination. None None 1 302 80 302 View
13vPnC+AlPO4/13vPnC+AlPO4 (After Vax 2 Core Study) Administered 13vPnC + AlPO4 0.5 mL IM at Year 0 (Vax 1) followed by 13vPnC+AlPO4 0.5 mL IM at Year 1 (Vax 2) in core study/NCT00269672 (6115A1-500). Events reported Day 1 up to Day 29 postvaccination. None None 3 139 26 139 View
13vPnC+AlPO4/23vPS (After Vax 2 Core Study) Administered 13vPnC+AlPO4 0.5 mL IM at Year 0 (Vax 1) followed by 23vPS 0.5 mL IM at Year 1 (Vax 2) in core study/NCT00269672 (6115A1-500). Events reported Day 1 up to Day 29 postvaccination. None None 1 128 35 128 View
13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study) Administered 13vPnC 0.5 mL IM at Year 0 (Vax 1) followed by 23vPS 0.5 mL IM at Year 1 (Vax 2) in core study/NCT00269672 (6115A1-500). Administered 13vPnC 0.5 mL IM at Year 2 (Vax 3) in follow-up study/NCT00500357 (6115A1-3009). For 13vPnC / 23vPS / 13vPnC (Vax 3 follow-up study) Other Adverse Events (non-serious events): the number affected (N) for nonsystematic (unsolicited) Other Adverse Events N=7; systematic (solicited) Any Local Reactions N=41; systematic (solicited) Any Systemic Events N=46. None None 2 105 46 105 View
13vPnC-AlPO4 (After Vax 1 Core Study) Administered 13vPnC-AlPO4 0.5 mL IM at Year 0 (Vax 1) in core study/NCT00269672 (6115A1-500). Events reported Day 1 up to Day 29 postvaccination. None None 4 304 58 304 View
13vPnC-AlPO4/23vPS (After Vax 2 Core Study) Administered 13vPnC-AlPO4 0.5 mL IM at Year 0 (Vax 1) followed by 23vPS 0.5 mL IM at Year 1 (Vax 2) in core study/NCT00269672 (6115A1-500). Events reported Day 1 up to Day 29 postvaccination. None None 1 273 76 273 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cardio-respiratory arrest NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Hip fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Bradycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Myocardial ischaemia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Angina unstable NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Myocardial infarction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Phimosis NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA View
Cholelithiasis NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
Exostosis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Spinal osteoarthritis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Intervertebral disc disorder 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
Hydrocephalus NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Myalgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system 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) 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
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
Limitation of arm movement (severe) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local reactions View
Fever (mild) ≥ 38 but <38.5 degrees C SYSTEMATIC_ASSESSMENT General disorders Systemic events View
Fever (moderate) ≥ 38.5 but <39 degrees C SYSTEMATIC_ASSESSMENT General disorders Systemic events View
Fever (severe) ≥ 39 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
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 appetitie SYSTEMATIC_ASSESSMENT General disorders Systemic events View
New muscle pain SYSTEMATIC_ASSESSMENT General disorders Systemic events View
Aggravated muscle pain SYSTEMATIC_ASSESSMENT General disorders Systemic events View
New joint pain SYSTEMATIC_ASSESSMENT General disorders Systemic events View
Aggravated joint pain SYSTEMATIC_ASSESSMENT General disorders Systemic events View
Lymphadenitis NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Cardiac failure congestive NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Angina pectoris NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Palpitations NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Hypothyroidism NON_SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA View
Conjunctivitis NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Dacryoadenitis acquired NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Eye pain NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Abdominal pain upper NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Toothache NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Hiatus hernia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Anal haemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Anal polyp NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Enterocolitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Erosive oesophagitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Melaena NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Abdominal discomfort NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Dyspepsia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Injection site pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Injection site movement impairment NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Injection site erythema NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Injection site swelling NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Chills NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Injection site inflammation NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Injection site joint movement impairment NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Malaise NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Asthenia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Chest pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Injection site induration NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Injection site pruritus NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Injection site rash NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Cholecystitis NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
Cholelithiasis NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
Hypersensitivity NON_SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA View
Pharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Influenza NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Gastroenteritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Bronchitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Sinusitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Rhinitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Cellulitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Cystitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Herpes simplex NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Tinea infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Tooth abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Herpes zoster NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Parotitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Viral pharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Viral rhinitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Lower respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Viral upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Arthropod bite NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Joint injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Joint sprain NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Gout NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Diabetes mellitus inadequate control NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Hyperkeratosis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Lentigo NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Skin laceration NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Stress fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Body temperature increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Decreased appetite NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hypercholesterolaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hypokalaemia 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
Muscle spasms NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Osteoarthritis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Joint swelling NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Arthritis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Back pain 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
Rotator cuff syndrome NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Monarthritis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Tendonitis 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
Migraine 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
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Urinary retention NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Vaginal haemorrhage NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Epistaxis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Rhinorrhoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal 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
Rhinitis allergic NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Dry throat NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Pleurisy NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Sneezing NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Rash macular NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Erythema NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Dermatitis contact NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Rash maculo-papular NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Rash vesicular NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Thrombophlebitis NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Musculoskeletal chest pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Drug hypersensitivity NON_SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA View
Gastroenteritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Cystitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Viral rhinitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations 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
Fever (any) ≥ 38 degrees Celsius (C) SYSTEMATIC_ASSESSMENT General disorders Systemic events View
Vertigo NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
Meniscus lesion NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Muscle strain NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Road traffic accident NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Animal bite NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Limb injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Muscle injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Pelvic fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Skeletal injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View