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 @ 2:13 AM
Ignite Modification Date: 2025-12-26 @ 12:41 AM
NCT ID: NCT02601560
Description: None
Frequency Threshold: 0
Time Frame: Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
Study: NCT02601560
Study Brief: To Evaluate Safety, Pharmacokinetics and Pharmacodynamics of MEDI6012 in Subjects With Stable Coronary Artery Disease
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
MEDI6012 80 mg IV Participants received a single IV dose of 80 mg MEDI6012 on Day 1. None None 0 6 5 6 View
MEDI6012 240 mg IV Participants received a single IV dose of 240 mg MEDI6012 on Day 1. None None 0 6 2 6 View
MEDI6012 800 mg IV Participants received a single IV dose of 800 mg MEDI6012 on Day 1. None None 0 6 4 6 View
Placebo Subcutaneous (SC) Participants received a single SC dose of placebo matched to MEDI6012 on Day 1 of the study. None None 0 4 2 4 View
MEDI6012 80 mg SC Participants received a single SC dose of 80 mg MEDI6012 on Day 1. None None 0 6 3 6 View
MEDI6012 600 mg SC Participants received a single SC dose of 600 mg MEDI6012 on Day 1. None None 0 6 4 6 View
Placebo Intravenous (IV) Participants received a single IV dose of placebo matched to MEDI6012 on Day 1 of the study. None None 0 8 3 8 View
MEDI6012 24 Milligram (mg) IV Participants received a single IV dose of 24 mg MEDI6012 on Day 1. None None 0 6 2 6 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Angina pectoris SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 19.1 View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 19.1 View
Diplopia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 19.1 View
Abdominal discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.1 View
Infusion site bruising SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.1 View
Infusion site reaction SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.1 View
Injection site bruising SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.1 View
Injection site erythema SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.1 View
Injection site haemorrhage SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.1 View
Injection site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.1 View
Injection site reaction SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.1 View
Medical device site irritation SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.1 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
High density lipoprotein decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.1 View
Respiratory rate increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.1 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 19.1 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.1 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.1 View
Limb discomfort SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.1 View
Burning sensation SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.1 View
Lethargy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.1 View
Migraine SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.1 View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.1 View
Slow speech SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.1 View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.1 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 19.1 View
Microalbuminuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 19.1 View
Benign prostatic hyperplasia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 19.1 View
Dermatitis allergic SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.1 View
Dermatitis contact SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.1 View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.1 View
Ecchymosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.1 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.1 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 19.1 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 19.1 View