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 @ 6:51 PM
Ignite Modification Date: 2025-12-25 @ 4:23 PM
NCT ID: NCT04402957
Description: None
Frequency Threshold: 5
Time Frame: 28 days
Study: NCT04402957
Study Brief: LSALT Peptide vs. Placebo to Prevent ARDS and Acute Kidney Injury in Patients Infected With SARS-CoV-2 (COVID-19)
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 100 mL drug-free IV saline infusion over 2 hours daily Placebo: 0.9% saline solution 0 None 8 31 22 31 View
LSALT 100 mL of 5 mg IV LSALT peptide infusion over 2 hours daily LSALT peptide: LSALT, a peptide drug with the sequence NH3-LSALTPSPSWLKYKAL-COOH, binds to dipeptidase-1 (DPEP-1) but does not inhibit its biologic enzymatic activity. LSALT peptide inhibits leukocyte recruitment in multiple experimental disease models through the direct inhibition of leukocyte adhesion to DPEP-1 present in lungs, kidney, and liver. 1 None 10 30 14 30 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v.23.0 View
Hypocalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v.23.0 View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v.23.0 View
Acute respiratory distress syndrome SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v.23.0 View
Acute respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v.23.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v.23.0 View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v.23.0 View
Sinus arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v.23.0 View
Sinus bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v.23.0 View
Bacterial sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v.23.0 View
Embolism SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA v.23.0 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA v.23.0 View
Cytokine release syndrome SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA v.23.0 View
Blood glucose increase SYSTEMATIC_ASSESSMENT Investigations MedDRA v.23.0 View
Delirium SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA v.23.0 View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v.23.0 View
Alkalosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v.23.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA v.23.0 View
Atrial tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v.23.0 View
Multiple organ dysfunction syndrome SYSTEMATIC_ASSESSMENT General disorders MedDRA v.23.0 View
Septic shock SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v.23.0 View
Superinfection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v.23.0 View
Alanine aminotransferase increase SYSTEMATIC_ASSESSMENT Investigations MedDRA v.23.0 View
Aspartate aminotransferase increase SYSTEMATIC_ASSESSMENT Investigations MedDRA v.23.0 View
Cerebrovascular accident SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v.23.0 View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA v.23.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Alanine aminotransferase increase SYSTEMATIC_ASSESSMENT Investigations MedDRA v.23.0 View
Aspartate aminotransferase increase SYSTEMATIC_ASSESSMENT Investigations MedDRA v.23.0 View
Gamma-glutamyltransferase increase SYSTEMATIC_ASSESSMENT Investigations MedDRA v.23.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v.23.0 View
Toothache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v.23.0 View
Tachypnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v.23.0 View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v.23.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA v.23.0 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v.23.0 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA v.23.0 View
Confusional state SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA v.23.0 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v.23.0 View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v.23.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA v.23.0 View