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 @ 3:01 PM
Ignite Modification Date: 2025-12-25 @ 1:24 PM
NCT ID: NCT00779259
Description: None
Frequency Threshold: 4.2
Time Frame: None
Study: NCT00779259
Study Brief: Drug - Drug Interaction Study Between Quinine Sulfate and Theophylline
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Quinine Alone On Day 5 in the afternoon, dosing of quinine sulfate (2 x 324 mg capsules) was initiated and continued every 8 hours without regard to meals through Day 11 None None 1 None 22 None View
Theophylline Alone At 7am on Day 1 after a fast of at least 10 hours, all subjects received a single dose of theophylline (300 mg as an immediate-release oral solution 80 mg/15 ml)followed by a 4 day washout period None None 0 None 7 None View
Theophylline Co-administered With Quinine At 7am on Day 12 after a fast of at least 10 hours, subjects received a single dose of theophylline (300 mg as an immediate-release oral solution 80 mg/15 ml) and quinine sulfate (2 x 324 mg capsules). None None 0 None 20 None View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
drug hypersensitivity SYSTEMATIC_ASSESSMENT General disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
syncope SYSTEMATIC_ASSESSMENT Nervous system disorders None View
tremor SYSTEMATIC_ASSESSMENT Nervous system disorders None View
confusional state SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
depressed mood SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
disorientation SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
restlessness SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
thinking abnormal SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
urinary hesitation SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
haemoptysis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
pharyngolaryngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
drug eruption SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
hyperhidrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
deafness bilateral SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
dysacusis SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
ear discomfort SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
ear pain SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
hearing impaired SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
hypoacusis SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
tinnitus SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
haematochezia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
retching SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
stomach discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
chest discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
chest pain SYSTEMATIC_ASSESSMENT General disorders None View
chills SYSTEMATIC_ASSESSMENT General disorders None View
feeling cold SYSTEMATIC_ASSESSMENT General disorders None View
feeling hot SYSTEMATIC_ASSESSMENT General disorders None View
feeling jittery SYSTEMATIC_ASSESSMENT General disorders None View
pallor SYSTEMATIC_ASSESSMENT General disorders None View
pyrexia SYSTEMATIC_ASSESSMENT General disorders None View
heart rate increased SYSTEMATIC_ASSESSMENT Investigations None View
anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
musculoskeletal chest pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders None View
deafness SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View