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 @ 9:29 PM
Ignite Modification Date: 2025-12-25 @ 7:14 PM
NCT ID: NCT00986232
Description: Number of participants reported as "At Risk" is the number of participants with follow-up.
Frequency Threshold: 1
Time Frame: Participants were followed for safety for 42 days after each scheduled vaccination.
Study: NCT00986232
Study Brief: ProQuad Dose Selection Study (V221-011)(COMPLETED)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
ProQuad (Low Dose) After Injection 1 One ProQuad™ (3.48 log10 plaque-forming units \[PFU\]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later. None None 2 378 286 378 View
ProQuad (Middle Dose) After Injection 1 One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later. None None 3 387 286 387 View
ProQuad (High Dose) After Injection 1 One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later. None None 1 377 289 377 View
M-M-R™ II + PUVV (Process Upgrade Varicella Vaccine) One M-M-R™ II (0.5-mL) SQ injection administered concomitantly with one PUVV (0.5-mL) SQ injection, at separate injection sites, on Day 0. None None 1 381 297 381 View
ProQuad (Low Dose) After Injection 2 One ProQuad™ (3.48 log10 plaque-forming units \[PFU\]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later. None None 1 353 253 353 View
ProQuad (Middle Dose) After Injection 2 One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later. None None 0 361 258 361 View
ProQuad (High Dose) After Injection 2 One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later. None None 2 358 254 358 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Bacteremia NON_SYSTEMATIC_ASSESSMENT Infections and infestations Merck CRISP View
Fever SYSTEMATIC_ASSESSMENT General disorders Merck CRISP View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Merck CRISP View
Acidosis NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders Merck CRISP View
Dehydration NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders Merck CRISP View
Seizure, febrile NON_SYSTEMATIC_ASSESSMENT Nervous system disorders Merck CRISP View
Laryngotracheobronchitis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders Merck CRISP View
Respiratory distress, newborn NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders Merck CRISP View
Asthma NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders Merck CRISP View
Otitis media NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders Merck CRISP View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Asthenia/Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders Merck CRISP View
Candidiasis NON_SYSTEMATIC_ASSESSMENT General disorders Merck CRISP View
Fever SYSTEMATIC_ASSESSMENT General disorders Merck CRISP View
Infection, Viral NON_SYSTEMATIC_ASSESSMENT Infections and infestations Merck CRISP View
Malaise NON_SYSTEMATIC_ASSESSMENT General disorders Merck CRISP View
Trauma NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications Merck CRISP View
Anorexia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders Merck CRISP View
Candidiasis, Oral NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Merck CRISP View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Merck CRISP View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Merck CRISP View
Asthma NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders Merck CRISP View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations Merck CRISP View
Miliaria Rubra NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Merck CRISP View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Merck CRISP View
Erythema (M-M-R II Injection-site) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Merck CRISP View
Pain/Tenderness/Soreness (M-M-R II Injection-site) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Merck CRISP View
Swelling (M-M-R II Injection-site) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Merck CRISP View
Ecchymosis (PUVV Injection-site) NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Merck CRISP View
Flatulence NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Merck CRISP View
Gastroenteritis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Merck CRISP View
Gastroenteritis, Infectious NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Merck CRISP View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Merck CRISP View
Lymphadenopathy NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders Merck CRISP View
Allergy NON_SYSTEMATIC_ASSESSMENT Immune system disorders Merck CRISP View
Crying NON_SYSTEMATIC_ASSESSMENT Nervous system disorders Merck CRISP View
Irritability NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders Merck CRISP View
Somnolence NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders Merck CRISP View
Bronchiolitis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders Merck CRISP View
Congestion, Nasal NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders Merck CRISP View
Congestion, Respiratory NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders Merck CRISP View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders Merck CRISP View
Infection, Respiratory, Upper NON_SYSTEMATIC_ASSESSMENT Infections and infestations Merck CRISP View
Influenza NON_SYSTEMATIC_ASSESSMENT Infections and infestations Merck CRISP View
Laryngotracheobronchitis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders Merck CRISP View
Pharyngitis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders Merck CRISP View
Rhinitis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders Merck CRISP View
Rhinorrhea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders Merck CRISP View
Sinusitis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders Merck CRISP View
Wheezing NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders Merck CRISP View
Bite/Sting, Non-Venomous NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications Merck CRISP View
Burn NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications Merck CRISP View
Dermatitis, Contact NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Merck CRISP View
Eczema NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Merck CRISP View
Rash, Diaper NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Merck CRISP View
Rash, Measles/Rubella-Like SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Merck CRISP View
Rash, Varicella-Like SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Merck CRISP View
Urticaria NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Merck CRISP View
Viral Exanthema NON_SYSTEMATIC_ASSESSMENT Infections and infestations Merck CRISP View
Conjunctivitis NON_SYSTEMATIC_ASSESSMENT Eye disorders Merck CRISP View
Otitis NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders Merck CRISP View
Otitis Media NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders Merck CRISP View
Otitis Media, Serous NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders Merck CRISP View
Pain, Ear NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders Merck CRISP View
Ecchymosis (ProQuad Injection-site) NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Merck CRISP View
Erythema (ProQuad Injection-site) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Merck CRISP View
Pain/Tenderness/Soreness (ProQuad Injection-site) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Merck CRISP View
Rash (ProQuad Injection-site) NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Merck CRISP View
Swelling (ProQuad Injection-site) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Merck CRISP View
Ecchymosis (M-M-R II Injection-site) NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Merck CRISP View
Erythema (PUVV Injection-site) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Merck CRISP View
Pain/Tenderness/Soreness (PUVV Injection-site) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Merck CRISP View
Rash (PUVV Injection-site) NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Merck CRISP View
Swelling (PUVV Injection-site) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Merck CRISP View