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 @ 1:13 AM
Ignite Modification Date: 2025-12-25 @ 11:23 PM
NCT ID: NCT01828593
Description: None
Frequency Threshold: 3
Time Frame: 24 weeks
Study: NCT01828593
Study Brief: Impact of SBI, a Medical Food, on Nutritional Status in Patients With HIV-associated Enteropathy
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
SBI 2.5 g Serum-derived bovine immunoglobulin protein isolate (SBI) 2.5 g - Subjects on 2.5 g in the placebo controlled phase and placebo free phase and subjects who went from placebo in the placebo controlled phase to 2.5 g in the placebo free phase Serum-derived bovine immunoglobulin protein isolate (SBI): SBI is a specially formulated light-colored protein powder composed of immunoglobulin (IgG) and other serum proteins similar to those found in colostrum and milk. SBI does not contain any milk products such as lactose, casein, or whey. SBI is gluten-free, dye-free, and soy-free. SBI is manufactured in accordance with current Good Manufacturing Practice (cGMP) and FDA guidelines for medical food ingredients. None None 2 55 26 55 View
SBI 5.0g Serum-derived bovine immunoglobulin protein isolate (SBI)5.0g - Subjects on 5.0 g in the placebo controlled phase and placebo free phase and subjects who went from placebo in the placebo controlled phase to 5.0 g in the placebo free phase Serum-derived bovine immunoglobulin protein isolate (SBI): SBI is a specially formulated light-colored protein powder composed of immunoglobulin (IgG) and other serum proteins similar to those found in colostrum and milk. SBI does not contain any milk products such as lactose, casein, or whey. SBI is gluten-free, dye-free, and soy-free. SBI is manufactured in accordance with current Good Manufacturing Practice (cGMP) and FDA guidelines for medical food ingredients. None None 1 47 20 47 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cerebral Haemorrhage NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Neuropathy Peripheral NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Subarachnoid Haemorrhage NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Alcohol Abuse NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Toothache NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Nausea NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Flatulence NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Gastritis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Myalgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Anxiety NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Blood Glucose Increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View