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 @ 3:28 AM
Ignite Modification Date:
2025-12-26 @ 2:09 AM
NCT ID:
NCT01536405
Description:
The All Subjects as Treated population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up results
Frequency Threshold:
5
Time Frame:
Up to 6 months (180 days) after vaccination 2
Study:
NCT01536405
Study Brief:
Safety, Tolerability, and Immunogenicity of Measles, Mumps, Rubella, and Varicella (MMRV) Vaccine Made With an Alternative Manufacturing Process (AMP)(V221-027)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| MMRV (AMP) | Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP) | None | None | 21 | 682 | 574 | 682 | View |
| MMRV (2006 Process) | Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process | None | None | 18 | 683 | 572 | 683 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Otitis media | None | Infections and infestations | MedDRA 16 | View |
| Periorbital cellulitis | None | Infections and infestations | MedDRA 16 | View |
| Pharyngitis streptococcal | None | Infections and infestations | MedDRA 16 | View |
| Pneumonia | None | Infections and infestations | MedDRA 16 | View |
| Pneumonia viral | None | Infections and infestations | MedDRA 16 | View |
| Respiratory syncytial virus bronchiolitis | None | Infections and infestations | MedDRA 16 | View |
| Respiratory syncytial virus infection | None | Infections and infestations | MedDRA 16 | View |
| Staphylococcal abscess | None | Infections and infestations | MedDRA 16 | View |
| Viral upper respiratory tract infection | None | Infections and infestations | MedDRA 16 | View |
| Vulval abscess | None | Infections and infestations | MedDRA 16 | View |
| Exposure via direct contact | None | Injury, poisoning and procedural complications | MedDRA 16 | View |
| Exposure via ingestion | None | Injury, poisoning and procedural complications | MedDRA 16 | View |
| Foreign body aspiration | None | Injury, poisoning and procedural complications | MedDRA 16 | View |
| Skull fracture | None | Injury, poisoning and procedural complications | MedDRA 16 | View |
| Upper limb fracture | None | Injury, poisoning and procedural complications | MedDRA 16 | View |
| Dehydration | None | Metabolism and nutrition disorders | MedDRA 16 | View |
| Metabolic acidosis | None | Metabolism and nutrition disorders | MedDRA 16 | View |
| Juvenile idiopathic arthritis | None | Musculoskeletal and connective tissue disorders | MedDRA 16 | View |
| Asthma | None | Respiratory, thoracic and mediastinal disorders | MedDRA 16 | View |
| Bronchial hyperreactivity | None | Respiratory, thoracic and mediastinal disorders | MedDRA 16 | View |
| Dyspnoea | None | Respiratory, thoracic and mediastinal disorders | MedDRA 16 | View |
| Hypoxia | None | Respiratory, thoracic and mediastinal disorders | MedDRA 16 | View |
| Status asthmaticus | None | Respiratory, thoracic and mediastinal disorders | MedDRA 16 | View |
| Kawasaki's disease | None | Vascular disorders | MedDRA 16 | View |
| Pyrexia | None | General disorders | MedDRA 16 | View |
| Abscess limb | None | Infections and infestations | MedDRA 16 | View |
| Bronchiolitis | None | Infections and infestations | MedDRA 16 | View |
| Cellulitis staphylcoccal | None | Infections and infestations | MedDRA 16 | View |
| Croup infectious | None | Infections and infestations | MedDRA 16 | View |
| Gastroenteritis | None | Infections and infestations | MedDRA 16 | View |
| Groin abscess | None | Infections and infestations | MedDRA 16 | View |
| Lobar pneumonia | None | Infections and infestations | MedDRA 16 | View |
| Lower respiratory tract infection | None | Infections and infestations | MedDRA 16 | View |
| Subcutaneous abscess | None | Infections and infestations | MedDRA 16 | View |
| Febrile convulsion | None | Nervous system disorders | MedDRA 16 | View |
| Status epilepticus | None | Nervous system disorders | MedDRA 16 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Diarrhoea | None | Gastrointestinal disorders | MedDRA 16 | View |
| Vomiting | None | Gastrointestinal disorders | MedDRA 16 | View |
| Injection site pain | None | General disorders | MedDRA 16 | View |
| Injection site swelling | None | General disorders | MedDRA 16 | View |
| Conjunctivitis | None | Eye disorders | MedDRA 16 | View |
| Injection site erythema | None | General disorders | MedDRA 16 | View |
| Pyrexia | None | General disorders | MedDRA 16 | View |
| Gastroenteritis | None | Infections and infestations | MedDRA 16 | View |
| Nasopharyngitis | None | Infections and infestations | MedDRA 16 | View |
| Otitis media | None | Infections and infestations | MedDRA 16 | View |
| Otitis media acute | None | Infections and infestations | MedDRA 16 | View |
| Pharyngitis | None | Infections and infestations | MedDRA 16 | View |
| Upper respiratory tract infection | None | Infections and infestations | MedDRA 16 | View |
| Viral infection | None | Infections and infestations | MedDRA 16 | View |
| Cough | None | Respiratory, thoracic and mediastinal disorders | MedDRA 16 | View |
| Rhinorrhoea | None | Respiratory, thoracic and mediastinal disorders | MedDRA 16 | View |
| Dermatitis diaper | None | Skin and subcutaneous tissue disorders | MedDRA 16 | View |
| Rash | None | Skin and subcutaneous tissue disorders | MedDRA 16 | View |