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 @ 10:50 PM
Ignite Modification Date: 2025-12-25 @ 8:20 PM
NCT ID: NCT00303069
Description: Specific systemic AEs: fatigue, headache, myalgia, and nausea for 14 days (D) postvaccination (PV). Injection-site AEs including maximum intensity/size for 5D PV. Elevated body temperatures for 5D PV. Subjects in Panel A (N=36) were actively followed for laboratory (lab) AEs for 7D PV. Any lab abnormalities at D7 PV were followed until resolution.
Frequency Threshold: 5
Time Frame: Following vaccination, all subjects in this study were followed for all clinical adverse experiences for 14 days postvaccination, and for vaccine-related serious adverse experiences and deaths for 84 days postvaccination (entire duration of the study).
Study: NCT00303069
Study Brief: V710 First-In-Man (FIM) Study (V710-001)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
V710 5 μg V710 5 μg single dose at baseline. None None 0 31 18 31 View
V710 30 μg V710 30 μg single dose at baseline. None None 0 28 19 28 View
V710 90 μg V710 90 μg single dose at baseline. None None 0 34 28 34 View
Placebo Saline placebo single dose at baseline. None None 0 31 17 31 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (9.0) View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (9.0) View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (9.0) View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA (9.0) View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (9.0) View
Injection-site erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (9.0) View
Injection-site pain SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (9.0) View
Injection-site swelling SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (9.0) View
Blood alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (9.0) View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (9.0) View
Hemoglobin decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA (9.0) View
Protein urine present SYSTEMATIC_ASSESSMENT Investigations MedDRA (9.0) View
White blood cell count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA (9.0) View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (9.0) View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (9.0) View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (9.0) View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (9.0) View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (9.0) View
Pharyngolaryngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (9.0) View