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: 2025-12-25 @ 2:53 AM
Ignite Modification Date: 2025-12-26 @ 1:34 AM
NCT ID: NCT00992433
Description: For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
Frequency Threshold: 5
Time Frame: Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination.
Study: NCT00992433
Study Brief: H1N1 Vaccine at Two Dose Levels in HIV Positive Adults
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
15 Mcg H1N1 Vaccine 15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21. None None 8 95 61 95 View
30 Mcg H1N1 Vaccine 30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21. None None 5 97 73 97 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Suicidal ideation NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 14.0 View
Cervicobrachial syndrome NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.0 View
Ectopic pregnancy NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA 14.0 View
Cellulitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Hypoaesthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.0 View
Perineal abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Convulsion NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.0 View
Pericarditis NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 14.0 View
Gastritis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Chronic obstructive pulmonary disease NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 14.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Blood pressure increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 14.0 View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Oropharyngeal pain NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 14.0 View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Feeling hot SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.0 View
Malaise SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.0 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 14.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Injection site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.0 View
Tenderness SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.0 View
Injection site erythema SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.0 View
Injection site swelling (functional grading) SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.0 View
Injection site swelling (measured) SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.0 View