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 @ 2:16 PM
Ignite Modification Date:
2025-12-25 @ 12:53 PM
NCT ID:
NCT00984295
Description:
Number of participants reported as "At Risk" is the number of participants with follow-up.
Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
Frequency Threshold:
1
Time Frame:
Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Study:
NCT00984295
Study Brief:
Frozen ProQuad Administered Concomitantly Versus Nonconcomitantly With Other Pediatric Vaccines
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Concomitant Group | Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0. | None | None | 11 | 929 | 831 | 929 | View |
| Nonconcomitant Group | Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42. | None | None | 3 | 479 | 435 | 479 | View |
| Control Group | Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42. | None | None | 1 | 467 | 411 | 467 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Fever | SYSTEMATIC_ASSESSMENT | General disorders | Merck CRISP | View |
| Hernia, inguinal | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | Merck CRISP | View |
| Infection, viral | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | Merck CRISP | View |
| Gastroenteritis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | Merck CRISP | View |
| Acidosis | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | Merck CRISP | View |
| Allergy, food | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | Merck CRISP | View |
| Hyponatremia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | Merck CRISP | View |
| Afebrile seizure | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | Merck CRISP | View |
| Seizure, febrile | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | Merck CRISP | View |
| Asthma | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | Merck CRISP | View |
| Laryngotracheobronchitis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | Merck CRISP | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | Merck CRISP | View |
| Wheezing | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | Merck CRISP | View |
| Cellulitis, orbital | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | Merck CRISP | View |
| Necrosis, testicle | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | Merck CRISP | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | 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 |
| Pain | 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 |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | Merck CRISP | View |
| Diarrhea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal 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 | Infections and infestations | Merck CRISP | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | Merck CRISP | View |
| Allergy | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | Merck CRISP | View |
| Irritability | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | Merck CRISP | View |
| Asthma | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | Merck CRISP | View |
| Bronchiolitis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | Merck CRISP | View |
| Bronchitis | 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 | Reproductive system and breast 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 |
| Contusion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | Merck CRISP | View |
| Dermatitis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 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 |
| Excoriation | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 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 |
| 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 |
| 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 |
| Erythema (Varivax Injection-site) | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | Merck CRISP | View |
| Pain/Tenderness/Soreness (Varivax Injection-site) | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | Merck CRISP | View |
| Swelling (Varivax Injection-site) | 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 (Tripedia Injection-site) | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | Merck CRISP | View |
| Erythema (Tripedia Injection-site) | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | Merck CRISP | View |
| Pain/Tenderness/Soreness (Tripedia Injection-site) | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | Merck CRISP | View |
| Swelling (Tripedia Injection-site) | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | Merck CRISP | View |
| Ecchymosis (Comvax Injection-site) | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | Merck CRISP | View |
| Erythema (Comvax Injection-site) | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | Merck CRISP | View |
| Induration (Comvax Injection-site) | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | Merck CRISP | View |
| Pain/Tenderness/Soreness (Comvax Injection-site) | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | Merck CRISP | View |
| Swelling (Comvax Injection-site) | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | Merck CRISP | View |