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 @ 12:54 AM
Ignite Modification Date: 2025-12-25 @ 11:09 PM
NCT ID: NCT01991067
Description: None
Frequency Threshold: 5
Time Frame: Adverse events were collected during the whole study period from enrollment to four weeks after third vaccination (Day 298-393 corresponds to 4 weeks after third vaccination)
Study: NCT01991067
Study Brief: Humoral and Cellular Immunity for TBE Vaccination in Allogeneic HSCT Recipients
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
HSCT Patients / TBE Virus Vaccine Study population: patients who had undergone an allogeneic HSCT 11 to 13 months ago Eligible patients will receive at least two TBE vaccinations (study visit 1 - day 0, study visit 2 -1month after the first vaccination) with a total of two doses of the TBE vaccine FSME-IMMUN®. Whenever possible, the patients will receive complete primary vaccination with a third dose of TBE vaccine (study visit 9 - 9 to 12 months after the first vaccination). TBE virus vaccine: TBE virus vaccine FSME Immun is used in both arms for the study population and the control group 0 None 4 19 15 19 View
Healthy Volunteers / TBE Virus Vaccine Clinical healthy volunteers will receive at least two TBE vaccinations (study visit 1 - day 0, study visit 2 -1month after the first vaccination) with a total of two doses of the TBE vaccine FSME IMMUN®. Whenever possible, the volunteers will receive complete primary vaccination with a third dose of TBE vaccine FSME IMMUN® (study visit 9 - 12 months after the first vaccination). TBE virus vaccine: TBE virus vaccine FSME Immun is used in both arms for the study population and the control group 0 None 0 15 6 15 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
cholecystolithiasis NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
haemometra NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
influenza NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
acute myeloid leukemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
increase of Graft-versus-host-disease (mucosal lesions) NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
skin exanthema NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
local swelling NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
local redness NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
shivering NON_SYSTEMATIC_ASSESSMENT General disorders None View
fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
sweating NON_SYSTEMATIC_ASSESSMENT General disorders None View
fever NON_SYSTEMATIC_ASSESSMENT General disorders None View
fever blister NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
increase of Graft-versus-host-disease (skin exanthema) NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
subjective tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
weight loss NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
swelling of parotid gland NON_SYSTEMATIC_ASSESSMENT Endocrine disorders None View
local pressure pain NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
local induration NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
cold-like symptoms NON_SYSTEMATIC_ASSESSMENT General disorders None View