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 @ 7:11 PM
Ignite Modification Date: 2025-12-25 @ 4:46 PM
NCT ID: NCT05888103
Description: None
Frequency Threshold: 5
Time Frame: AEs are reported from first dose of study treatment until end of study treatment plus 30 days after the last study visit (or 90 days after the last administration of study drug, whichever is longer) up to a maximum timeframe of approximately 360 days
Study: NCT05888103
Study Brief: Efficacy and Safety of Inclisiran as Monotherapy in Chinese Adults With Low or Moderate ASCVD Risk and Elevated Low-density Lipoprotein Cholesterol.
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo - Inclisiran: Extension Part Placebo - inclisiran: extension part 0 None 2 101 20 101 View
Inclisiran - Inclisiran: Core Part Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran): core part 0 None 5 103 40 103 View
Placebo - Inclisiran: Core Part Placebo - inclisiran: core part 0 None 3 104 27 104 View
Inclisiran - Inclisiran: Extension Part Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran): extension part 0 None 1 100 25 100 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Acute coronary syndrome SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (27.1) View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA (27.1) View
Vertigo positional SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA (27.1) View
Haemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (27.1) View
Inguinal hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (27.1) View
Appendicitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (27.1) View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (27.1) View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (27.1) View
Intervertebral disc protrusion SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (27.1) View
Rotator cuff syndrome SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (27.1) View
Thyroid cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (27.1) View
Cerebrovascular accident SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (27.1) View
Cervical radiculopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (27.1) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (27.1) View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (27.1) View
Blood creatine phosphokinase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (27.1) View
Blood glucose increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (27.1) View