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 @ 1:18 PM
Ignite Modification Date: 2025-12-25 @ 12:25 PM
NCT ID: NCT04258995
Description: Safety population are participants who received 1 dose of the investigational product and had at least 1 safety assessment after receiving the booster dose. Medical Dictionary for Regulatory Activities (MedDRA) v23.1 was followed for AE reporting.
Frequency Threshold: 5
Time Frame: The time period for actively eliciting and collecting AEs and SAEs for each participant began from the time the participant provided informed consent, through and including Visit 2 (1 month after booster dose) for AEs and through and including Visit 3 for MAEs and SAEs (6 months after booster dose).
Study: NCT04258995
Study Brief: A TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A BOOSTER DOSE OF A GROUP B STREPTOCOCCUS 6 VALENT POLYSACCHARIDE CONJUGATE VACCINE (GBS6) IN HEALTHY 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
GBS6 20 μg With AlPO4 Participants who received a primary dose of GBS6 (5 μg, 10 µg, or 20 µg) with AlPO4 in Study C1091001 received a single booster dose of GBS6 (20 µg) formulated with AlPO4 intramuscularly on Day 1 and were followed up to 6 months. 0 None 1 76 59 76 View
GBS6 20 μg Without AlPO4 Participants who received a primary dose of GBS6 (5 μg, 10 µg, or 20 µg) without AlPO4 in Study C1091001 received a single booster dose of GBS6 (20 µg) formulated without AlPO4 intramuscularly on Day 1 and were followed up to 6 months. 0 None 0 75 54 75 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Thermal burn NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v23.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v23.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v23.1 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA v23.1 View
Injection site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA v23.1 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v23.1 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v23.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v23.1 View