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 @ 11:52 PM
Ignite Modification Date: 2025-12-25 @ 9:47 PM
NCT ID: NCT03403751
Description: Safety data obtained during study visits associated with Study Days 1, 2, 3, 7, 10, 14, 21, and 28 were systematically assessed throughout the study. In addition, data from spontaneously reported AEs were included in safety assessments.
Frequency Threshold: 5
Time Frame: Adverse events (AEs) reported here were collected from study drug administration through the Day 29 visit (28 days after study drug dosing).
Study: NCT03403751
Study Brief: Phase 3 Study of Reltecimod vs Placebo in Patients With Sepsis-associated Acute Kidney Injury
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Reltecimod 0.5 mg/kg Single IV infusion of 0.5 mg/kg Reltecimod (at a concentration of 1 mg/mL) 5 None 12 28 7 28 View
Placebo Single IV infusion of 0.5 mL/kg of 0.9% sodium chloride (volume equivalent with Reltecimod dosing schema) 6 None 13 30 8 30 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Gastrointestinal anastomotic complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Gastrointestinal anastomotic leak SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Urethral injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Fluid overload SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyperkalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Cerebral infarction SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Device occlusion SYSTEMATIC_ASSESSMENT Product Issues None View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Acute pulmonary edema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Chronic obstructive pulmonary disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Leukocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Atrial flutter SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Intestinal ischemia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Intra-abdominal fluid collection SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Organ failure SYSTEMATIC_ASSESSMENT General disorders None View
Hepatic failure SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Abdominal wall infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pneumonia escherichia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Postoperative wound infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Retroperitoneal abscess SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Septic shock SYSTEMATIC_ASSESSMENT Infections and infestations None View
Chemical peritonitis SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Thrombocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Septic shock SYSTEMATIC_ASSESSMENT Infections and infestations None View
Delirium SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Fluid overload SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View