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 @ 5:08 PM
Ignite Modification Date: 2025-12-24 @ 5:08 PM
NCT ID: NCT03929250
Description: A standard multi-system questionnaire will record the type and severity (range 0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, 5 = fatal) of any adverse events.
Frequency Threshold: 0
Time Frame: 0, 6, 12 and 24 hours after administration of each dose level (2g CAW or 4g CAW)
Study: NCT03929250
Study Brief: Pharmacokinetics of Centella Asiatica in the Elderly
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
2g CAW Dose 2g of Centella asiatica water extract in a standardized product. 2g Centella asiatica water extract product: 2g Centella asiatica water extract product is a powder containing Centella asiatica water extract and excipients to improve palatability, color matching and dispersability in water. It will be consumed on an empty stomach orally suspended in 10-12 ounces of water. 0 None 0 8 4 8 View
4g CAW Dose 4g of Centella asiatica water extract in a standardized product. 4g Centella asiatica water extract product: 4g Centella asiatica water extract product is a powder containing Centella asiatica water extract and excipients to improve palatability, color matching and dispersability in water. It will be consumed on an empty stomach orally suspended in 10-12 ounces of water. 0 None 0 8 4 8 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Excessive sleep SYSTEMATIC_ASSESSMENT General disorders None View
Disappointment SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Boredom SYSTEMATIC_ASSESSMENT Social circumstances None View
Weakness/fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Musculoskeletal pain or stiffness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Tinnitus SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Blurred vision SYSTEMATIC_ASSESSMENT Eye disorders None View
Hypotension SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Fainting/dizziness SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Coughing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Peripheral edema or swelling SYSTEMATIC_ASSESSMENT Vascular disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gas/indigestion SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Increased thirst SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dry throat SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abnormal or metallic taste in mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal pain/cramps SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Decreased appetite SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Belching SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Increased urination SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urine color change SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Itchiness/dryness SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Skin color change SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Redness SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash/hives SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Bruising SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Skin puffiness/ tissue fluid SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Ecchymosis, indurate SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Weight gain SYSTEMATIC_ASSESSMENT General disorders None View
Weight loss SYSTEMATIC_ASSESSMENT General disorders None View