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 @ 4:12 PM
Ignite Modification Date:
2025-12-25 @ 2:12 PM
NCT ID:
NCT00985166
Description:
The number of participants listed as "at risk" is the number of participants with follow-up.
0/0 indicates that subjects in this treatment group did not receive the indicated vaccine.
Frequency Threshold:
1
Time Frame:
None
Study:
NCT00985166
Study Brief:
A Study of ProQuad in Healthy 4 to 6 Year Old Children (V221-014)
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™ + Placebo | ProQuad™ (measles, mumps, rubella, and varicella vaccine) + placebo administered concomitantly at separate injection sites on Day 1. | None | None | 1 | 397 | 292 | 397 | View |
| M-M-R™ II + Placebo | M-M-R™ II + placebo administered concomitantly at separate injection sites on Day 1. | None | None | 0 | 205 | 150 | 205 | View |
| M-M-R™ II + VARIVAX™ | VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 1. | None | None | 0 | 193 | 140 | 193 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Pyelonephritis - Not other wise Specified (NOS) | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 6.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Ear pain | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 6.0 | View |
| Conjunctivitis | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 6.0 | View |
| Lacrimation increased | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 6.0 | View |
| Abdominal pain NOS | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 6.0 | View |
| Abdominal pain upper | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 6.0 | View |
| Diarrhoea NOS | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 6.0 | View |
| Dyspepsia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 6.0 | View |
| Vomiting NOS | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 6.0 | View |
| Influenza like illness | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 6.0 | View |
| Malaise | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 6.0 | View |
| Pain NOS | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 6.0 | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 6.0 | View |
| Venipuncture site pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 6.0 | View |
| Seasonal allergy | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 6.0 | View |
| Ear infection NOS | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 6.0 | View |
| Gastroenteritis viral NOS | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 6.0 | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 6.0 | View |
| Otitis media NOS | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 6.0 | View |
| Pharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 6.0 | View |
| Pharyngitis streptococcal | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 6.0 | View |
| Pneumonia NOS | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 6.0 | View |
| Sinusitis NOS | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 6.0 | View |
| Upper respiratory tract infection NOS | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 6.0 | View |
| Viral infection NOS | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 6.0 | View |
| Arthropod bite | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 6.0 | View |
| Excoriation | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 6.0 | View |
| Thermal burn | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 6.0 | View |
| Appetite decreased NOS | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 6.0 | View |
| Pain in extremity | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 6.0 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 6.0 | View |
| Somnolence | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 6.0 | View |
| Irritability | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 6.0 | View |
| Asthma NOS | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 6.0 | View |
| Bronchospasm NOS | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 6.0 | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 6.0 | View |
| Nasal congestion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 6.0 | View |
| Pharyngolaryngeal pain | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 6.0 | View |
| Rhinorrhoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 6.0 | View |
| Dermatitis contact | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 6.0 | View |
| Eczema | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 6.0 | View |
| Heat rash | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 6.0 | View |
| Rash NOS | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 6.0 | View |
| Rash papular | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 6.0 | View |
| Injection site bruising (M-M-R II Injection-site) | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 6.0 | View |
| Injection site erythema (M-M-R II Injection-site) | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 6.0 | View |
| Injection site pain (M-M-R II Injection-site) | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 6.0 | View |
| Injection site swelling (M-M-R II Injection-site) | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 6.0 | View |
| Injection site bruising (ProQuad Injection-site) | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 6.0 | View |
| Injection site erythema (ProQuad Injection-site) | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 6.0 | View |
| Injection site pain (ProQuad Injection-site) | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 6.0 | View |
| Injection site pruritus (ProQuad Injection-site) | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 6.0 | View |
| Injection site rash (ProQuad Injection-site) | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 6.0 | View |
| Injection site swelling (ProQuad Injection-site) | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 6.0 | View |
| Injection site bruising (Varivax Injection-site) | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 6.0 | View |
| Injection site erythema (Varivax Injection-site) | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 6.0 | View |
| Injection site nodule (Varivax Injection-site) | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 6.0 | View |
| Injection site pain (Varivax Injection-site) | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 6.0 | View |
| Injection site pruritus (Varivax Injection-site) | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 6.0 | View |
| Injection site swelling (Varivax Injection-site) | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 6.0 | View |