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 @ 12:58 PM
Ignite Modification Date: 2025-12-25 @ 12:18 PM
NCT ID: NCT04152161
Description: Serious adverse events and non-serious adverse events were collected in Safety Population. An AE was classified as solicited if it was proactively recorded through a structured assessment (e.g., diary card) through 7 days post vaccination. Unsolicited AEs collected outside the daily card were presented separately. A participant who had a solicited event that was ongoing at Day 7 would have the event counted as both a solicited AE and an unsolicited AE.
Frequency Threshold: 1
Time Frame: Solicited AEs (comprising of injection site pain, redness, swelling, headache, fatigue, gastrointestinal symptoms, and fever) were recorded on diary cards (systematic assessment) for 7 days after vaccination. Solicited events ongoing at Day 7 were also recorded as unsolicited AEs. Unsolicited AEs were collected through Day 28, SAEs and All-cause mortality through Month 6 and Serious adverse drug reactions (ADRs) through Month 48.
Study: NCT04152161
Study Brief: Bacille Calmette Guerin (BCG) Revaccination of Healthy Adolescents for the Prevention of Mycobacterium Tuberculosis Sustained Infection
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Bacille Calmette Guerin (BCG) Group Participants were randomized to receive a single 0.1 mL volume of BCG vaccine SSI, administered intradermally in deltoid region of the upper arm. 0 None 3 918 800 918 View
Placebo Group Participants were randomized to receive a single 0.1 mL volume of normal saline, administered intradermally in deltoid region of the upper arm. 1 None 3 917 540 917 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Sinusitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Subperiosteal abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Intentional overdose NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.0 View
Meningitis tuberculous NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Appendicitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Fibula fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.0 View
Tibia fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.0 View
Traumatic haemothorax NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Gastrointestinal Symptoms SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Injection site swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.0 View
Injection site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.0 View
Injection site erythema SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.0 View
Injection site ulcer NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.0 View
Injection site pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.0 View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.0 View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.0 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.0 View