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 @ 2:24 AM
Ignite Modification Date: 2025-12-26 @ 12:56 AM
NCT ID: NCT01154634
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT01154634
Study Brief: Study to Investigate the Pharmacodynamic Effect of a Single Dose of AZD2516 in Healthy Male Subjects
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
AZD2516 5 mg Loading dose: 3 \* AZD2516 1 mg capsules. Maintenance doses: 1 \* AZD2516 1 mg capsule, 2 \* placebo capsules and 1 \* AZD2516 1 mg capsule, 2 \* placebo capsules. None None 0 20 4 20 View
AZD2516 16 mg Loading dose: 2 \* AZD2516 5mg capsule, 1 \* placebo capsule. Maintenance dose: 3 \* AZD2516 1 mg capsule and 3 \* AZD2516 1 mg capsule. None None 0 20 8 20 View
AZD2516 40 mg Loading dose: 2 \* AZD2616 10 mg capsules, 1 \* placebo capsule. Maintenance dose: 2 \* AZD2616 5 mg capsules, 1 \* placebo capsule and 2 \* AZD2616 5 mg capsules, 1 \* placebo capsule. None None 0 20 12 20 View
Placebo Loading dose: 3 \* placebo capsules. Maintenance dose: 3 \* placebo capsules and 3 \* placebo capsules. None None 0 20 3 20 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Sinus Headache None Nervous system disorders MedDRA 10.0 View
Somnolence None Nervous system disorders MedDRA 10.0 View
Disturbance In Attention None Nervous system disorders MedDRA 10.0 View
Dizziness None Nervous system disorders MedDRA 10.0 View
Headache None Nervous system disorders MedDRA 10.0 View
Balance Disorder None Nervous system disorders MedDRA 10.0 View
Paraesthesia None Nervous system disorders MedDRA 10.0 View
Flatulence None Gastrointestinal disorders MedDRA 10.0 View
Abdominal Pain None Gastrointestinal disorders MedDRA 10.0 View
Gastrointestinal Pain None Gastrointestinal disorders MedDRA 10.0 View
Euphoric Mood None Psychiatric disorders MedDRA 10.0 View
Daydreaming None Psychiatric disorders MedDRA 10.0 View
Diplopia None Eye disorders MedDRA 10.0 View
Vision Blurred None Eye disorders MedDRA 10.0 View
Vertigo None Ear and labyrinth disorders MedDRA 10.0 View
Pyuria None Renal and urinary disorders MedDRA 10.0 View