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 @ 11:10 PM
Ignite Modification Date: 2025-12-25 @ 8:43 PM
NCT ID: NCT04916769
Description: The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment.
Frequency Threshold: 5
Time Frame: Up to 12 weeks
Study: NCT04916769
Study Brief: Bioavailability of Bosutinib Administered as Capsule Contents Mixed With Applesauce or Yogurt Relative to Intact Capsules Under Fed Condition
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Bosutinib 500 mg Capsule Contents + Applesauce 45 mL Bosutinib 500 mg single dose was administered as capsule contents mixed with 45 mL applesauce. 0 None 0 16 11 16 View
Bosutinib 500 mg Capsule Contents + Yogurt 45 mL Bosutinib 500 mg single dose was administered as capsule contents mixed with 45 mL yogurt. 0 None 0 17 14 17 View
Bosutinib 500 mg Intact Capsule Bosutinib 500 mg single dose was administered as intact capsules. 0 None 0 18 15 18 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal discomfort NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v24.1 View
Abdominal distension NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v24.1 View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v24.1 View
Anorectal discomfort NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v24.1 View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v24.1 View
Eructation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v24.1 View
Flatulence NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v24.1 View
Food poisoning NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v24.1 View
Haematemesis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v24.1 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v24.1 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v24.1 View
Asthenia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v24.1 View
Chills NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v24.1 View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v24.1 View
Feeling of body temperature change NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v24.1 View
Vessel puncture site haematoma NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v24.1 View
Vessel puncture site reaction NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v24.1 View
Ear infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v24.1 View
Tooth abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v24.1 View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v24.1 View
Hepatic enzyme increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA v24.1 View
Decreased appetite NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v24.1 View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v24.1 View
Limb discomfort NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v24.1 View
Myalgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v24.1 View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v24.1 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v24.1 View
Nasal congestion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v24.1 View
Rhinorrhoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v24.1 View
Upper respiratory tract irritation NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v24.1 View
Alopecia NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v24.1 View
Ecchymosis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v24.1 View
SARS-CoV-2 test positive NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA v24.1 View