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 @ 5:10 PM
Ignite Modification Date: 2025-12-25 @ 2:47 PM
NCT ID: NCT00824850
Description: The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
Frequency Threshold: 0
Time Frame: Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
Study: NCT00824850
Study Brief: Study Evaluating Prevnar Infant Long-term Immune Response Versus Prevnar Naive Cohort
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
7vPnC / 13vPnC 13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8. Adverse Events include Local reactions and Systemic events collected on the diary card and reported in the diary-related case report form (systematic assessment) and other Adverse Events collected on the case report form (non-systematic methods). Other Adverse Events N=22; Local reactions N=38; Systemic events N=38. None None 0 38 38 38 View
MnCC / 13vPnC 13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8. Adverse Events include Local reactions and Systemic events collected on the diary card and reported in the diary-related case report form (systematic assessment) and other Adverse Events collected on the case report form (non-systematic methods). Other Adverse Events N=20; Local reactions N=36; Systemic events N=36. None None 0 36 36 36 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Lymphoid tissue hyperplasia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Palpitations NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Congenital flat feet NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA View
Cerumen impaction NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
Ear congestion NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
Ear pain NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Injection site pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Injection site swelling NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Seasonal allergy NON_SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA View
Otitis externa NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Acute sinusitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Bronchitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Gastritis viral NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pneumonia 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
Viral upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Contusion NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Joint sprain NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Ankle fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Avulsion fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Clavicle fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Concussion NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Excoriation NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Hand fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Muscle strain NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Traumatic brain injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Decreased appetite NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Dehydration NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Patellofemoral pain syndrome NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Skin papilloma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Hypersomnia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Somnolence NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Presyncope NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Syncope 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
Dysmenorrhoea NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Gynaecomastia NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Asthma 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
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Nasal congestion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Respiratory disorder NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Acne NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Dermatitis contact NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Ingrowing nail NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Tenderness: Any SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reaction View
Tenderness: Significant SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reaction View
Swelling: Any SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reaction View
Swelling: Mild SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reaction View
Swelling: Moderate SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reaction View
Redness: Any SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reaction View
Redness: Mild SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reaction View
Redness: Moderate SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reaction View
Fever ≥38 degrees C but ≤39 degrees C SYSTEMATIC_ASSESSMENT General disorders Systemic Event View
Decreased appetite SYSTEMATIC_ASSESSMENT General disorders Systemic Event View
Irritability SYSTEMATIC_ASSESSMENT General disorders Systemic Event View
Irritability: Mild SYSTEMATIC_ASSESSMENT General disorders Systemic Event View
Irritability: Moderate SYSTEMATIC_ASSESSMENT General disorders Systemic Event View
Increased sleep SYSTEMATIC_ASSESSMENT General disorders Systemic Event View
Increased sleep: Mild SYSTEMATIC_ASSESSMENT General disorders Systemic Event View
Increased sleep: Moderate SYSTEMATIC_ASSESSMENT General disorders Systemic Event View
Increased sleep: Severe SYSTEMATIC_ASSESSMENT General disorders Systemic Event View
Decreased sleep SYSTEMATIC_ASSESSMENT General disorders Systemic Event View
Decreased sleep: Mild SYSTEMATIC_ASSESSMENT General disorders Systemic Event View
Decreased sleep: Moderate SYSTEMATIC_ASSESSMENT General disorders Systemic Event View
Rash SYSTEMATIC_ASSESSMENT General disorders Systemic Event View
Rash: Mild SYSTEMATIC_ASSESSMENT General disorders Systemic Event View
Decreased appetite: Mild SYSTEMATIC_ASSESSMENT General disorders Systemic Event View
Decreased appetite: Moderate SYSTEMATIC_ASSESSMENT General disorders Systemic Event View