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 @ 6:54 PM
Ignite Modification Date: 2025-12-25 @ 4:27 PM
NCT ID: NCT00492557
Description: SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
Frequency Threshold: 0
Time Frame: AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
Study: NCT00492557
Study Brief: Study Evaluating Safety and Immunogenicity of 13-Valent Pneumococcal Conjugate Vaccine With Influenza 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+TIV Single 0.5 mL 13vPnC and a single 0.5 mL TIV, administered IM. None None 4 576 307 576 View
Placebo Single 0.5 mL 13vPnC placebo vaccine (administered 1 month after a single 0.5 mL 13vPnC and a single 0.5 mL TIV, IM \[13vPnC + TIV\]). None None 8 559 194 559 View
Placebo+TIV Single 0.5 mL 13vPnC placebo vaccine and a single 0.5 mL TIV, administered IM. None None 0 575 256 575 View
13vPnC Single 0.5 mL 13vPnC (administered 1 month after single 0.5 mL 13vPnC placebo vaccine and a single 0.5 mL TIV, IM \[Placebo + TIV\]). None None 5 558 237 558 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Angina pectoris NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Cardiac failure NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Myocardial infarction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Atrial fibrillation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Gastric ulcer NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Duodenal ulcer perforation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Gastrointestinal haemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Peritonitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Cholecystitis NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Femoral neck fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Sternal fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Endoscopy small intestine NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Electrocardiogram ST segment elevation NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Spinal column stenosis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Basal cell carcinoma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Bladder neoplasm 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
Chronic obstructive pulmonary disease NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Cardiac pacemaker insertion NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab 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
Limitation of arm movement (severe) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local reactions View
Fever ≥ 38 degrees C but < 38.5 degrees C SYSTEMATIC_ASSESSMENT General disorders Systemic events View
Fever ≥ 38.5 degrees C but < 39 degrees C SYSTEMATIC_ASSESSMENT General disorders Systemic events View
Fever ≥ 39 degrees C but ≤ 40.0 degrees C SYSTEMATIC_ASSESSMENT General disorders Systemic events View
Fever > 40.0 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 appetite SYSTEMATIC_ASSESSMENT General disorders Systemic events View
New muscle pain SYSTEMATIC_ASSESSMENT General disorders Systemic events View
Any aggravated muscle pain SYSTEMATIC_ASSESSMENT General disorders Systemic events View
New joint pain SYSTEMATIC_ASSESSMENT General disorders Systemic events View
Any aggravated joint pain SYSTEMATIC_ASSESSMENT General disorders Systemic events View
Arrhythmia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Angina pectoris NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Atrial fibrillation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Cardiac failure NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Cardiac disorder NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Myocardial ischaemia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Palpitations NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Deafness unilateral NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
Vertigo NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
Glaucoma NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Cataract NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Conjunctivitis NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Conjunctival haemorrhage NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Rectal haemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Colitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Oral pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Cheilitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Dyspepsia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Haemorrhoids NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Injection site haematoma NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Injection site pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Injection site erythema NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Injection site pruritus NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Injection site swelling NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Malaise NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Oedema peripheral NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Sensation of foreign body NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Influenza like illness NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Localised infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Cystitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Bronchitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Enterovirus infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Eyelid infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Gastroenteritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Influenza NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Oesophageal candidiasis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Oral herpes NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Otitis externa NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Tooth infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Tracheobronchitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Viral infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Sinusitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Rhinitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Herpes zoster NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Otitis media NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Erysipelas NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Fungal infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Fungal skin infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Gastroenteritis viral NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Tonsillitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Viral upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Contusion NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Fall NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Procedural pain NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Tendon rupture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Traumatic haematoma NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Wrist fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Concussion NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Corneal abrasion NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Fibula fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Joint dislocation NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Post procedural haematoma NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Radius fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Rib fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Ulna fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Total lung capacity decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Cardiac murmur NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Weight decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Hypercholesterolaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Diabetes mellitus NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Gout NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Pain in extremity NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue 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
Osteoarthritis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Bursitis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Groin pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Joint swelling NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Muscle spasms NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Musculoskeletal pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Osteitis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Spinal osteoarthritis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Tendonitis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Tenosynovitis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Neck pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Flank pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Myositis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Balance disorder NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Cervicobrachial syndrome NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Memory impairment NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Restless legs syndrome NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Transient ischaemic attack NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Hypoaesthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Sciatica NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Vertebrobasilar insufficiency NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Post-traumatic stress disorder NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Sleep disorder NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Dysuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Urinary incontinence NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Haematuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Nephrocalcinosis NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Urge incontinence NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Bartholin's cyst NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Fibrocystic breast disease NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Chronic obstructive pulmonary disease NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Epistaxis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Nasal congestion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Diaphragmatic hernia 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
Throat irritation NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Asthma NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Dyspnoea exertional NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Pharyngolaryngeal pain NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Erythema NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Pruritus NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Dermatitis bullous NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Drug eruption NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Eczema NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Dental prosthesis user NON_SYSTEMATIC_ASSESSMENT Social circumstances MedDRA View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Phlebitis NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Haematoma NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View