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 @ 11:58 AM
Ignite Modification Date: 2025-12-25 @ 11:56 AM
NCT ID: NCT00395161
Description: For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.
Frequency Threshold: 5
Time Frame: Adverse events were collected for 28 days.
Study: NCT00395161
Study Brief: The CRISIS Prevention 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
Daily Nutriceutical Supplementation Subjects assigned to this group received zinc (20 mg), selenium (40 mcg ages 1-3 yrs, 100 mcg age 3-5 yrs, 200 mcg age 5-12 yrs, 400 mcg adolescent), and glutamine (0.3 g/kg) each morning, and intravenous metoclopramide (0.2 mg/kg, maximum 10 mg) every 12 hrs. None None 73 148 119 148 View
Whey Protein Subjects assigned to the whey protein group received 0.3 g/kg beneprotein each morning and intravenous saline every 12 hrs. None None 70 139 112 139 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.0 View
Cardiac arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.0 View
Cardiopulmonary arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.0 View
Myocardial ischemia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.0 View
Pericardial effusion SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.0 View
Sickle cell anaemia SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA 13.0 View
Diabetes insipidus SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 13.0 View
Cortical blindness SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.0 View
Multiple organ failure SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
Withdrawal syndrome SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
Bacteremia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Catheter site cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Encephalitis viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Nosocomial infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Tracheitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Lipase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.0 View
Oxygen saturation decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.0 View
PCO2 increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.0 View
WBC increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.0 View
Hyperkalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.0 View
Hypoglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.0 View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.0 View
Hypovolemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.0 View
Metabolic acidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.0 View
Acute myeloid leukemia recurrent SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 13.0 View
Acute mental status changes SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.0 View
Agitation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.0 View
Mental status changes SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.0 View
Anuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 13.0 View
Hemorrhagic cystitis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 13.0 View
Oliguria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 13.0 View
Renal failure NOS SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 13.0 View
ARDS SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
Acute respiratory distress syndrome SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
Respiratory distress SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
Stridor SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
Acute hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 13.0 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 13.0 View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
GI bleed SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Gastrointestinal bleeding SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Intra-abdominal hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Ischemic colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Peritonitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Brain death SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
Fever SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
Hyperthermia SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
Brain herniation SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.0 View
Subdural haematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.0 View
Amylase high SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.0 View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.0 View
Blood culture positive SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.0 View
Blood potassium decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.0 View
CSF WBC increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.0 View
Culture stool positive SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.0 View
Culture urine positive SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.0 View
Decreased INR SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.0 View
Cerebral edema SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
Cerebral infarct SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
Choreoathetoid movements SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
Consciousness decreased SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
Edema cerebral SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
Intracranial hemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
Intracranial pressure increased SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
Ischemic stroke SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
Shaking SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
Acute respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
Failure respiratory SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
Hypoxemia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
Paralysis of diaphragm SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
Pulmonary edema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
Pulmonary hemorrhage SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 13.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Fever SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
Hyperthermia SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
Hypothermia SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
Blood albumin decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.0 View
Lipase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.0 View
Platelets decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.0 View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.0 View
Agitation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.0 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
Tachypnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 13.0 View
Coagulopathy SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 13.0 View
Leukocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 13.0 View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.0 View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.0 View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Emesis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
Nosocomial infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
BUN increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.0 View
Blood magnesium decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.0 View
Blood phosphorus decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.0 View
Blood potassium decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.0 View
Blood sodium decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.0 View
Hematocrit decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.0 View
Hemoglobin decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.0 View
Oxygen saturation decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.0 View
PCO2 increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.0 View
Acidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.0 View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.0 View
Hyperkalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.0 View
Hypernatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.0 View
Hypocalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.0 View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.0 View
Hypomagnesemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.0 View
Hypophosphatemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.0 View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
Oliguria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 13.0 View
Atelectasis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
Respiratory distress SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
Stridor SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
Skin breakdown SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 13.0 View