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:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2025-12-25 @ 9:58 PM
NCT ID:
NCT00312858
Description:
None
Frequency Threshold:
0
Time Frame:
None
Study:
NCT00312858
Study Brief:
Concomitant Use of Hepatitis A Vaccine With Measles, Mumps, Rubella and Varicella Vaccine and Pneumococcal 7-Valent Conjugate Vaccine in Healthy 12-Month-Old Children (V251-067)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Arm 1: VAQTA™ + ProQuad™ + Prevnar™ | VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit. | None | None | 2 | None | 231 | None | View |
| Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™ | VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit. | None | None | 6 | None | 172 | None | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.0 | View |
| Cellulitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.0 | View |
| Perineal Abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.0 | View |
| Genital Abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.0 | View |
| Bronchopneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.0 | View |
| Gastroenteritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.0 | View |
| Dehydration | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 11.0 | View |
| Febrile Convulsion | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 11.0 | View |
| Gastrointestinal Haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 11.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Lymphadenopathy | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 11.0 | View |
| Ear Pain | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 11.0 | View |
| Otorrhea | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 11.0 | View |
| Conjunctivitis | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 11.0 | View |
| Eye Discharge | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 11.0 | View |
| Eye Swelling | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 11.0 | View |
| Abdominal Pain Upper | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 11.0 | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 11.0 | View |
| Diarrhea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 11.0 | View |
| Flatulence | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 11.0 | View |
| Gastroesophageal Reflux Disease | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 11.0 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 11.0 | View |
| Oral Pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 11.0 | View |
| Teething | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 11.0 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 11.0 | View |
| Body Temperature | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 11.0 | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 11.0 | View |
| Irritability | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 11.0 | View |
| Pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 11.0 | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 11.0 | View |
| Drug Hypersensitivity | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 11.0 | View |
| Multiple Allergies | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 11.0 | View |
| Seasonal Allergy | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 11.0 | View |
| Acute Sinusitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.0 | View |
| Adenovirus Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.0 | View |
| Body Tinea | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.0 | View |
| Bronchitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.0 | View |
| Candida Nappy Rash | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.0 | View |
| Candidiasis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.0 | View |
| Conjunctivitis Bacterial | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.0 | View |
| Conjunctivitis Infective | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.0 | View |
| Conjunctivitis Viral | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.0 | View |
| Croup Infectious | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.0 | View |
| Ear Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.0 | View |
| Enterobiasis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.0 | View |
| Eye Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.0 | View |
| Gastroenteritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.0 | View |
| Gastroenteritis Viral | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.0 | View |
| Impetigo | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.0 | View |
| Influenza | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.0 | View |
| Mycoplasma Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.0 | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.0 | View |
| Otitis Media | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.0 | View |
| Otitis Media Acute | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.0 | View |
| Pharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.0 | View |
| Pharyngitis Streptococcal | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.0 | View |
| Pharyngotonsillitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.0 | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.0 | View |
| Respiratory Syncytial Virus Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.0 | View |
| Rhinitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.0 | View |
| Roseola | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.0 | View |
| Sinusitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.0 | View |
| Skin Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.0 | View |
| Tinea Pedis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.0 | View |
| Upper Respiratory Tract Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.0 | View |
| Viraemia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.0 | View |
| Viral Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.0 | View |
| Viral Pharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.0 | View |
| Viral Skin Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.0 | View |
| Viral upper respiratory tract Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.0 | View |
| Arthropod Bite | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 11.0 | View |
| Arthropod Sting | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 11.0 | View |
| Contusion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 11.0 | View |
| Head Injury | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 11.0 | View |
| Lower Limb Fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 11.0 | View |
| Sunburn | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 11.0 | View |
| Thermal Burn | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 11.0 | View |
| Anorexia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 11.0 | View |
| Decreased Appetite | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 11.0 | View |
| Hypervitaminosis A | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 11.0 | View |
| Iron Deficiency | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 11.0 | View |
| Muscular Weakness | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | View |
| Pain In Extremity | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | View |
| Febrile Convulsion | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 11.0 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 11.0 | View |
| Lethargy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 11.0 | View |
| Tremor | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 11.0 | View |
| Crying | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 11.0 | View |
| Insomnia | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 11.0 | View |
| Restlessness | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 11.0 | View |
| Sleep Disorder | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 11.0 | View |
| Penile Discharge | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 11.0 | View |
| Asthma | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | View |
| Bronchial Hyperreactivity | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | View |
| Nasal Congestion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | View |
| Paranasal Sinus Hypersecretion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | View |
| Pharyngolaryngeal Pain | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | View |
| Respiratory Tract Congestion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | View |
| Rhinalgia | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | View |
| Rhinitis Allergic | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | View |
| Rhinorrhea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | View |
| Sinus Congestion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | View |
| Sneezing | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | View |
| Wheezing | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | View |
| Dermatitis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 11.0 | View |
| Dermatitis Allergic | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 11.0 | View |
| Dermatitis Atopic | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 11.0 | View |
| Dermatitis Contact | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 11.0 | View |
| Dermatitis Diaper | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 11.0 | View |
| Eczema | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 11.0 | View |
| Erythema | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 11.0 | View |
| Erythema Multiforme | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 11.0 | View |
| Rash | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 11.0 | View |
| Rash Macular | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 11.0 | View |
| Rash Maculo-papular | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 11.0 | View |
| Rash Morbilliform | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 11.0 | View |
| Rash Rubelliform | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 11.0 | View |
| Rash Vesicular | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 11.0 | View |
| Urticaria | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 11.0 | View |
| Bruising, Injection site for VAQTA™ | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 11.0 | View |
| Erythema, Injection site for VAQTA™ | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 11.0 | View |
| Haemorrhage, Injection site for VAQTA™ | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 11.0 | View |
| Nodule, Injection site for VAQTA™ | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 11.0 | View |
| Pain, Injection site for VAQTA™ | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 11.0 | View |
| Rash, Injection site for VAQTA™ | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 11.0 | View |
| Reaction, Injection site for VAQTA™ | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 11.0 | View |
| Swelling, Injection site for VAQTA™ | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 11.0 | View |
| Warmth, Injection site for VAQTA™ | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 11.0 | View |