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 @ 7:24 PM
Ignite Modification Date: 2025-12-25 @ 5:03 PM
NCT ID: NCT00669903
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00669903
Study Brief: Study to Asses Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of AZD0328 in Patients With Schizophrenia
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
AZD0328 Low Dose Group AZD0328 Low dose group (0.00093 to 0.0028 mg oral solution) None None 0 23 17 23 View
AZD0328 Optimal Dose Group AZD0328 Optimal dose group (0.0048 to 0.0329 mg oral solution) None None 0 37 22 37 View
AZD0328 High Dose Group AZD0328 High dose group (0.075 to 0.675 mg oral solution) None None 0 18 11 18 View
Placebo Placebo None None 1 22 11 22 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pulmonary Embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
DYSPEPSIA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
HEADACHE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.1 View
MYALGIA SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.1 View
CONSTIPATION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
INSOMNIA SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 11.1 View
LETHARGY SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.1 View
SEDATION SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.1 View
ANXIETY SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 11.1 View
NASAL CONGESTION SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.1 View
TOOTHACHE SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
NAUSEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
COUGH SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.1 View