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 @ 12:39 AM
Ignite Modification Date: 2025-12-25 @ 10:50 PM
NCT ID: NCT03198767
Description: None
Frequency Threshold: 1
Time Frame: Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
Study: NCT03198767
Study Brief: Effects of Carbohydrate in Diet and Supplements on the Gastrointestinal Tolerability of LIK066
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Part A: LIK066 + 0% CHO Part A: LIK066 + 0% carbohydrate CHO 0 None 0 24 19 24 View
Part A: LIK066 + 8% CHO Part A: LIK066 + 8% carbohydrate CHO 0 None 0 6 5 6 View
Part B: LIK066 + 50% CHO + NS Daily dose of 50 mg LIK066+50% carbohydrate + no supplement (NS) 0 None 0 24 21 24 View
Part B: LIK066 + 50% CHO + PS Daily dose of 50 mg LIK066+50% carbohydrate + 6 g psyllium (PS) 0 None 0 24 19 24 View
Part B: LIK066 + 50% CHO CC Daily dose of 50 mg LIK066+50% carbohydrate +1g calcium carbonate (CC) 0 None 0 24 22 24 View
Part A: LIK066 + 50% CHO Part A: LIK066 + 50% carbohydrate CHO 0 None 0 24 21 24 View
Part A: LIK066 + 25% CHO Part A: LIK066 + 25% carbohydrate CHO 0 None 0 24 19 24 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.1 View
Abdominal discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.1 View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.1 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.1 View
Abdominal pain lower SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.1 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.1 View
Peripheral swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.1 View
Vessel puncture site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.1 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 20.1 View
Dysuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 20.1 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.1 View
Scratch SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20.1 View
Burning sensation SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.1 View
Scab SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 20.1 View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.1 View
Gastrointestinal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.1 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 20.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.1 View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 20.1 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 20.1 View
Anorectal discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.1 View