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 @ 4:17 AM
Ignite Modification Date: 2025-12-26 @ 3:18 AM
NCT ID: NCT04987320
Description: Safety Analysis Set: included all randomized participants who received olpasiran.
Frequency Threshold: 0
Time Frame: Up to 225 days
Study: NCT04987320
Study Brief: A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Olpasiran in Chinese Participants With Elevated Serum Lipoprotein(a)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Olpasiran Low Dose Participants were administered a single dose of olpasiran low dose as a subcutaneous injection on Day 1. 0 None 1 12 11 12 View
Olpasiran High Dose Participants were administered a single dose of olpasiran high dose as a subcutaneous injection on Day 1. 0 None 1 12 9 12 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Clavicle fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Haemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Toothache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Influenza like illness SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Injection site bruising SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Injection site erythema SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Injection site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Injection site swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Covid-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Periodontitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Rhinitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
Dental restoration failure SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
Thermal burn SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
Type 2 diabetes mellitus SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
Fracture pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
Musculoskeletal chest pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Hypoaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.0 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Rhinorrhoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Hyperhidrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.0 View
Rash macular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.0 View
Urticaria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.0 View