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 @ 2:37 AM
Ignite Modification Date: 2025-12-26 @ 1:15 AM
NCT ID: NCT00461734
Description: None
Frequency Threshold: 5
Time Frame: 5 years
Study: NCT00461734
Study Brief: PROTECT-PACE STUDY - The Protection of Left Ventricular Function During Right Ventricular Pacing
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
RV Apex RV lead placement site: Patients randomised to RV apical lead placement site None None 78 120 6 120 View
RV High Septum RV lead placement site: Patients randomised to RV high septal lead placement site None None 81 120 0 120 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
anemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 19.0 View
SOB NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 19.0 View
diabets NON_SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 19.0 View
rectal bleeding NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
chest pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
bile duct NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 19.0 View
infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
trauma NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.0 View
angiography NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
dehydration NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 19.0 View
arthritis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.0 View
carcinoma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.0 View
stroke NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
urinary tract infection NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 19.0 View
prostate NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 19.0 View
pneumonia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
dermatitis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.0 View
bypass NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 19.0 View
raynaud's disease NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 19.0 View
death NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
product issue NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 19.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
musculoskeletal pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.0 View