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 @ 4:50 PM
Ignite Modification Date: 2025-12-25 @ 2:34 PM
NCT ID: NCT00560950
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT00560950
Study Brief: Revaccination With PNEUMOVAX(TM) 23 in Older Adults (V110-007)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
1st Revaccination Group Received primary vaccination with Pneumovax 23 during the initial phase and 1st revaccination in the extension phase None None 0 71 48 None View
2nd Revaccination Group Received 1st revaccination with Pneumovax 23 during the initial phase and 2nd revaccination in the extension phase None None 0 71 60 None View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Lymphadenopathy NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 11.0 View
Dry Eye NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 11.0 View
Lacrimation Increased NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 11.0 View
Macular Degeneration NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 11.0 View
Abdominal Pain Upper NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Aphthous NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Oral Disorder NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Anaesthesia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Coldness NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Erythema SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Induration NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Oedema Peripheral NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Pain (Injection site) SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Paraesthesia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Peripheral Coldness NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Pruritus NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Warmth NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Cystitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Procedural Pain NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Blood Pressure Increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.0 View
Hyperglycaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11.0 View
Type 2 Diabetes Mellitus NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11.0 View
Back Pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.0 View
Joint Range of Motion Decreased NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.0 View
Musculoskeletal Pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.0 View
Musculoskeletal Stiffness NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.0 View
Neck Pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.0 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Hypoaesthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Migrane NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Disorientation NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 11.0 View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 11.0 View
Restlessness NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 11.0 View
Rhinorrhoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Pruritus Generalised NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.0 View