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 @ 1:17 PM
Ignite Modification Date: 2025-12-25 @ 12:25 PM
NCT ID: NCT00726895
Description: 24 subjects were enrolled in this study. One subject dropped out of the study prior to receiving both interventions. 23 subjects were administered the Quinine Sulfate 1 x 324 mg capsule dose and 24 subjects were admistered the Quinine Sulfate 2 x 324 mg capusle dose.
Frequency Threshold: 0
Time Frame: None
Study: NCT00726895
Study Brief: A Dose Proportionality Study of Quinine Sulfate Capsules Under Fasting Conditions
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Treatment A - Quinine Sulfate Capsules 1 x 324 mg Dose All subjects received each of the two study regimens (Treatment A - Quinine Sulfate 1 x 324 mg capsule, Treatment B - Quinine Sulfate 2 x 324 mg capsules) in a randomly assigned sequence of dosing periods, each followed by a washout period of 7 days. None None 0 23 6 23 View
Treatment B - Quinine Sulfate Capsules 2 x 324 mg Dose All subjects received each of the two study regimens (Treatment A - Quinine Sulfate 1 x 324 mg capsule, Treatment B - Quinine Sulfate 2 x 324 mg capsules) in a randomly assigned sequence of dosing periods, each followed by a washout period of 7 days. None None 0 24 10 24 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Loss of appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dysmenorrhea SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Generalized pain SYSTEMATIC_ASSESSMENT General disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Joint injury SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Myalgia in extremities SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Night Sweats SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Pain in extremity SYSTEMATIC_ASSESSMENT General disorders None View
Pallor SYSTEMATIC_ASSESSMENT General disorders None View
Pharyngolaryngeal - Sore throat SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Rigors SYSTEMATIC_ASSESSMENT General disorders None View
Skin laceration SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Stomach discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Sweating increased SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Tinnitus SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Tonsillitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View