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 @ 4:26 PM
Ignite Modification Date: 2025-12-25 @ 2:19 PM
NCT ID: NCT02676466
Description: To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
Frequency Threshold: 0
Time Frame: Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
Study: NCT02676466
Study Brief: The ENRGISE (ENabling Reduction of Low-Grade Inflammation in SEniors) Pilot Study
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Fish Oil Placebo This group will receive a placebo which will be matching to the Omega-3 fish oil. The placebo corn oil are obtained in gel caps and they have identical shape, color, taste and weight. The doses will be administered at doses corresponding to the Omega-3 fish oil. Corn Oil (Fish oil Placebo): The corn oil placebo gel caps will be identical in shape, color, taste and weight as the Omega-3 fish oil. 2 None 17 71 46 71 View
Losartan Placebo This group will receive a placebo which will be matching to the losartan. The placebo cellulose based capsule are obtained in 25 mg and 50 mg capsules. The shell capsules are cellulose based. Placebo and LO have identical shape, color, taste and weight. the doses will be administered at doses corresponding to the losartan. Cellulose Based (Losartan Placebo): The placebo cellulose based capsules will be identical in shape, color, taste and weight as the losartan capsules. 0 None 4 17 16 17 View
Fish Oil Active This group will receive the Omega-3 fish oil which will be administered at a dose of 1.4 grams per day for the first six months. Based on tolerability and inflammation level, dose may either continue at 1.4 grams per day or be increased to 2.8 grams per day for the remaining six month. Omega-3 fish oil: The Omega-3 fish oil will be provided in 700 mg gelcaps. The starting dose will be 1.4 g/day of fish oil and continue until the 6 month visit. If the average of IL-6 measured at 3- and 6-month visits does not decrease by \>40% vs. baseline (average of screening visits 1 and 2), we increase the dose to 2.8 g/day. 0 None 30 109 73 109 View
Losartan Active This group will receive the Losartan which will be administered at a starting dose of 25 milligrams per day. Based on tolerability, losartan will continue at a dose of either 25 milligrams per day or 50 milligrams per day for the first six months. Based on continued tolerability and inflammation level, dose may either continue at 25 or 50 milligrams per day or be increased to 100 milligrams per day for the remaining six months. Losartan: The Losartan will be provided in 25 mg and 50 mg capsules. The starting dose will be 25 mg/day, if tolerated, then stepped up to 50 mg/day. If there are no safety concerns, a continuation of 50 mg/day will be provided until the 6 month visit. If the average of IL-6 measured at 3- and 6-month visits does not decrease by \>40% vs. baseline (average of screening visits 1 and 2), an increase to the dose of 100 mg/day. 1 None 3 26 22 26 View
Fish Oil Active + Losartan Active This group will receive both the Losartan and Omega-3 fish oil. Losartan will be administered at a starting dose of 25 milligrams per day. Based on tolerability, losartan will continue at a dose of either 25 milligrams per day or 50 milligrams per day for the first six months. Based on continued tolerability and inflammation level, dose may either continue at 25 or 50 milligrams per day or be increased to 100 milligrams per day for the remaining six months. Omega-3 fish oil will be administered at a dose of 1.4 grams per day for the first six months. Based on tolerability and inflammation level, dose may either continue at 1.4 grams per day or be increased to 2.8 grams per day for the remaining six months. 0 None 8 26 20 26 View
Fish Oil Active + Losartan Placebo This group will receive the Omega-3 fish oil which will be administered at a dose of 1.4 grams per day for the first six months. Based on tolerability and inflammation level, dose may either continue at 1.4 grams per day or be increased to 2.8 grams per day for the remaining six month. In addition, this group will receive a placebo which will be matching to the losartan. The placebo cellulose based capsule are obtained in 25 mg and 50 mg capsules. The shell capsules are cellulose based. Placebo and LO have identical shape, color, taste and weight. the doses will be administered at doses corresponding to the losartan. 0 None 3 13 12 13 View
Fish Oil Placebo + Losartan Active This group will receive a placebo which will be matching to the Omega-3 fish oil. The placebo corn oil are obtained in gel caps and they have identical shape, color, taste and weight. The doses will be administered at doses corresponding to the Omega-3 fish oil. In addition, this group will receive the Losartan which will be administered at a starting dose of 25 milligrams per day. Based on tolerability, losartan will continue at a dose of either 25 milligrams per day or 50 milligrams per day for the first six months. Based on continued tolerability and inflammation level, dose may either continue at 25 or 50 milligrams per day or be increased to 100 milligrams per day for the remaining six months. 0 None 2 13 10 13 View
Fish Oil Placebo + Losartan Placebo This group will receive a placebo which will be matching to both the omega-3 fish oil and losartan which will be administered at doses corresponding to doses administered for omega-3 fish oil and losartan throughout the 12 month study. 0 None 5 14 11 14 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
ACUTE CORONARY SYNDROME SYSTEMATIC_ASSESSMENT Cardiac disorders None View
ACUTE KIDNEY INJURY SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
AMNESIA SYSTEMATIC_ASSESSMENT Nervous system disorders None View
AORTIC VALVE DISEASE SYSTEMATIC_ASSESSMENT Cardiac disorders None View
ARTHRITIS SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
ATRIAL FIBRILLATION SYSTEMATIC_ASSESSMENT Cardiac disorders None View
BACK PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
BRONCHIAL INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations None View
CARDIAC ARREST SYSTEMATIC_ASSESSMENT Cardiac disorders None View
CARDIAC DISORDERS - OTHER, SPECIFY SYSTEMATIC_ASSESSMENT Cardiac disorders None View
CHEST PAIN - CARDIAC SYSTEMATIC_ASSESSMENT Cardiac disorders None View
COLONIC HEMORRHAGE SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
COUGH SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
DEHYDRATION SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
DIZZINESS SYSTEMATIC_ASSESSMENT Nervous system disorders None View
ESOPHAGEAL OBSTRUCTION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
FALL SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
FRACTURE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
GASTROINTESTINAL DISORDERS - OTHER, SPECIFY SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
HEART FAILURE SYSTEMATIC_ASSESSMENT Cardiac disorders None View
HEMATOMA SYSTEMATIC_ASSESSMENT Vascular disorders None View
HEPATIC FAILURE SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
HIP FRACTURE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
HYPERGLYCEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
HYPOTENSION SYSTEMATIC_ASSESSMENT Vascular disorders None View
INTRACRANIAL HEMORRHAGE SYSTEMATIC_ASSESSMENT Nervous system disorders None View
JOINT RANGE OF MOTION DECREASED LUMBAR SPINE SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
LUNG INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations None View
MYOCARDIAL INFARCTION SYSTEMATIC_ASSESSMENT Cardiac disorders None View
NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS) - OTHER, SPECIFY SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
NON-CARDIAC CHEST PAIN SYSTEMATIC_ASSESSMENT General disorders None View
ORTHOPEDIC NEUROLOGIC SYSTEMATIC_ASSESSMENT Nervous system disorders None View
PAIN IN EXTREMITY SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
PERIPHERAL MOTOR NEUROPATHY SYSTEMATIC_ASSESSMENT Nervous system disorders None View
RENAL AND URINARY DISORDERS - OTHER, SPECIFY SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
RENAL CALCULI SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
RESPIRATORY FAILURE SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
SCALP PAIN SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
SICK SINUS SYNDROME SYSTEMATIC_ASSESSMENT Cardiac disorders None View
SINUS BRADYCARDIA SYSTEMATIC_ASSESSMENT Cardiac disorders None View
SKIN AND SUBCUTANEOUS TISSUE DISORDERS - OTHER, SPECIFY SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
SKIN INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations None View
SMALL INTESTINAL OBSTRUCTION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
STROKE SYSTEMATIC_ASSESSMENT Nervous system disorders None View
SURGICAL AND MEDICAL PROCEDURES - OTHER, SPECIFY SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
SURGICAL AND MEDICAL PROCEDURES, OTHER, LEFT KNEE REPLACEMENT SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
SYNCOPE SYSTEMATIC_ASSESSMENT Nervous system disorders None View
THROMBOEMBOLIC EVENT SYSTEMATIC_ASSESSMENT Vascular disorders None View
TRANSIENT ISCHEMIC ATTACKS SYSTEMATIC_ASSESSMENT Nervous system disorders None View
TREMOR SYSTEMATIC_ASSESSMENT Nervous system disorders None View
UPPER RESPIRATORY INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations None View
URINARY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations None View
URINARY TRACT OBSTRUCTION SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
CARDIAC ARREST SYSTEMATIC_ASSESSMENT Cardiac disorders None View
HEART FAILURE SYSTEMATIC_ASSESSMENT Cardiac disorders None View
MYOCARDIAL INFARCTION SYSTEMATIC_ASSESSMENT Cardiac disorders None View
ACUTE CORONARY SYNDROME SYSTEMATIC_ASSESSMENT Cardiac disorders None View
ACUTE KIDNEY INJURY SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
AMNESIA SYSTEMATIC_ASSESSMENT Nervous system disorders None View
AORTIC VALVE DISEASE SYSTEMATIC_ASSESSMENT Cardiac disorders None View
ARTHRITIS SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
ATRIAL FIBRILLATION SYSTEMATIC_ASSESSMENT Cardiac disorders None View
BACK PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
BRONCHIAL INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations None View
CARDIAC DISORDERS - OTHER, SPECIFY SYSTEMATIC_ASSESSMENT Cardiac disorders None View
CHEST PAIN - CARDIAC SYSTEMATIC_ASSESSMENT Cardiac disorders None View
COLONIC HEMORRHAGE SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
COUGH SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
DEHYDRATION SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
DIZZINESS SYSTEMATIC_ASSESSMENT Nervous system disorders None View
ESOPHAGEAL OBSTRUCTION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
FALL SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
FRACTURE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
GASTROINTESTINAL DISORDERS - OTHER, SPECIFY SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
HEART FAILURE SYSTEMATIC_ASSESSMENT Cardiac disorders None View
HEMATOMA SYSTEMATIC_ASSESSMENT Vascular disorders None View
HEPATIC FAILURE SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
HIP FRACTURE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
HYPERGLYCEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
HYPOTENSION SYSTEMATIC_ASSESSMENT Vascular disorders None View
INTRACRANIAL HEMORRHAGE SYSTEMATIC_ASSESSMENT Nervous system disorders None View
JOINT RANGE OF MOTION DECREASED LUMBAR SPINE SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
LUNG INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations None View
MYOCARDIAL INFARCTION SYSTEMATIC_ASSESSMENT Cardiac disorders None View
NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS) - OTHER, SPECIFY SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
NON-CARDIAC CHEST PAIN SYSTEMATIC_ASSESSMENT General disorders None View
ORTHOPEDIC NEUROLOGIC SYSTEMATIC_ASSESSMENT Nervous system disorders None View
PAIN IN EXTREMITY SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
PERIPHERAL MOTOR NEUROPATHY SYSTEMATIC_ASSESSMENT Nervous system disorders None View
RENAL AND URINARY DISORDERS - OTHER, SPECIFY SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
RENAL CALCULI SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
RESPIRATORY FAILURE SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
SCALP PAIN SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
SICK SINUS SYNDROME SYSTEMATIC_ASSESSMENT Cardiac disorders None View
SINUS BRADYCARDIA SYSTEMATIC_ASSESSMENT Cardiac disorders None View
SKIN AND SUBCUTANEOUS TISSUE DISORDERS - OTHER, SPECIFY SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
SKIN INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations None View
SMALL INTESTINAL OBSTRUCTION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
STROKE SYSTEMATIC_ASSESSMENT Nervous system disorders None View
SURGICAL AND MEDICAL PROCEDURES - OTHER, SPECIFY SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
SURGICAL AND MEDICAL PROCEDURES, OTHER, LEFT KNEE REPLACEMENT SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
SYNCOPE SYSTEMATIC_ASSESSMENT Nervous system disorders None View
THROMBOEMBOLIC EVENT SYSTEMATIC_ASSESSMENT Vascular disorders None View
TRANSIENT ISCHEMIC ATTACKS SYSTEMATIC_ASSESSMENT Nervous system disorders None View
TREMOR SYSTEMATIC_ASSESSMENT Nervous system disorders None View
UPPER RESPIRATORY INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations None View
URINARY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations None View
URINARY TRACT OBSTRUCTION SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS) - OTHER, SPECIFY SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
NON-SERIOUS AES - Any Adverse Event SYSTEMATIC_ASSESSMENT General disorders None View
NON-SERIOUS AES - Atrial Fibrillation SYSTEMATIC_ASSESSMENT General disorders None View
NON-SERIOUS AES - Cough SYSTEMATIC_ASSESSMENT General disorders None View
NON-SERIOUS AES - Dizziness/Presyncope SYSTEMATIC_ASSESSMENT General disorders None View
NON-SERIOUS AES - Fall (mechanical) SYSTEMATIC_ASSESSMENT General disorders None View
NON-SERIOUS AES - Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
NON-SERIOUS AES - Syncope SYSTEMATIC_ASSESSMENT General disorders None View
NON-SERIOUS AES - GI Upset SYSTEMATIC_ASSESSMENT General disorders None View
NON-SERIOUS AES - Hyperglycemia SYSTEMATIC_ASSESSMENT General disorders None View
NON-SERIOUS AES - Hyperkalemia SYSTEMATIC_ASSESSMENT General disorders None View
NON-SERIOUS AES - Severe Hyperglycemic Episode SYSTEMATIC_ASSESSMENT General disorders None View
NON-SERIOUS AES - Drop in hemoglobin SYSTEMATIC_ASSESSMENT General disorders None View
NON-SERIOUS AES - Hypotension SYSTEMATIC_ASSESSMENT General disorders None View
NON-SERIOUS AES - Drop in eGFR SYSTEMATIC_ASSESSMENT General disorders None View
NON-SERIOUS AES - Acute Renal Failure SYSTEMATIC_ASSESSMENT General disorders None View
NON-SERIOUS AES - Angiodema SYSTEMATIC_ASSESSMENT General disorders None View
NON-SERIOUS AES - Stroke or TIA SYSTEMATIC_ASSESSMENT General disorders None View
NON-SERIOUS AES - Other SYSTEMATIC_ASSESSMENT General disorders None View