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 @ 11:16 PM
Ignite Modification Date: 2025-12-25 @ 8:54 PM
NCT ID: NCT01905956
Description: The causality of the AEs and intake of IP was assessed by the clinician. Three subjects who were excluded (due to violation of inclusion/exclusion criteria, and treatment compliance) in the Intention-to-treat population were included in the adverse events analysis.
Frequency Threshold: 0
Time Frame: During the treatment period ie. 12 weeks.
Study: NCT01905956
Study Brief: Safety and Efficacy of IQP- AK-102 in Reducing Body Weight
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 2 capsules per dose, 3 times daily Placebo None None 0 56 12 56 View
IQP-AK-102 2 capsules per dose, three times daily IQP-AK-102 None None 1 58 12 58 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Prostate Cancer NON_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
Common cold or upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Toothache or dental extraction NON_SYSTEMATIC_ASSESSMENT General disorders None View
Gastrointestinal complaints NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Headaches and Migraine NON_SYSTEMATIC_ASSESSMENT General disorders None View
Distortion and contusion of knee NON_SYSTEMATIC_ASSESSMENT General disorders None View
Allergic Rhinitis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Abcess of the skin NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Acute Sciatica (Dorsalgia) NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Macular degeneration NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Infection of urinary tract NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Nausea & Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Flatulence NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View