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 @ 3:52 AM
Ignite Modification Date: 2025-12-26 @ 2:41 AM
NCT ID: NCT03480802
Description: The population reported was all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23 (PPV23).
Frequency Threshold: 5
Time Frame: V114 and Prevnar 13™ arms: NSAEs from Day 1 up to 14 days after vaccination 1, and SAEs from Day 1 up to Week 8. V114 (Post-PPV23) and Prevnar 13™ (Post-PPV23) arms: NSAEs from week 8 up to 14 days after vaccination 2, and SAEs after Week 8 vaccination up to Month 6. All-Cause Mortality: From screening up to Month 6.
Study: NCT03480802
Study Brief: A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 Followed by PNEUMOVAX™23 in Adults Infected With Human Immunodeficiency Virus (HIV) (V114-018)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
V114 (Post-PPV23) Participants received a single 0.5 mL IM injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 (PPV23) at Week 8 (Vaccination 2). 0 None 2 150 88 150 View
V114 Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1). 0 None 3 152 103 152 View
Prevnar 13™ Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1). 0 None 0 150 88 150 View
Prevnar 13™ (Post-PPV23) Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PPV23 at Week 8 (Vaccination 2). 0 None 6 148 99 148 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Chondrocalcinosis pyrophosphate SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 22.1 View
Transient ischaemic attack SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22.1 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 22.1 View
Appendicitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.1 View
Herpes zoster SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.1 View
Peritonitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.1 View
Soft tissue infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.1 View
Foot fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 22.1 View
Dry gangrene SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 22.1 View
Suicide attempt SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 22.1 View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 22.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 22.1 View
Injection site erythema SYSTEMATIC_ASSESSMENT General disorders MedDRA 22.1 View
Injection site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 22.1 View
Injection site swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA 22.1 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 22.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22.1 View