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 @ 11:37 PM
Ignite Modification Date: 2025-12-25 @ 9:27 PM
NCT ID: NCT00600756
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00600756
Study Brief: Comparison of the Subjective Well-being and Tolerability of Quetiapine XR to Risperidone
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Quetiapine XR Experimental - oral, once daily, tablets of 400 mg to 800 mg None None 45 391 238 391 View
Risperidone Active Comparator - oral, once daily, tablets of 2 mg to 6 mg None None 26 402 258 402 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Schizophrenia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 11.1 View
Psychotic Disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 11.1 View
Abnormal Behavior SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 11.1 View
Acute Psychosis SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 11.1 View
Agitation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 11.1 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 11.1 View
Suicide Attempt SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 11.1 View
Aggression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 11.1 View
Alcohol Abuse SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 11.1 View
Schizoaffective Disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 11.1 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 11.1 View
Confusional State SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 11.1 View
Delusion SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 11.1 View
Mental Disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 11.1 View
Panic Attack SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 11.1 View
Schizophreniform Disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 11.1 View
Suicidal Ideation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 11.1 View
Brain Stem Stroke SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.1 View
Epilepsy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.1 View
Extrapyramidal Disorder SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.1 View
Ischaemic Stroke SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.1 View
Neuroleptic Malignant Syndrome SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.1 View
Psychomotor Hyperactivity SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.1 View
Transient Ischaemic Attack SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.1 View
Humerus Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.1 View
Joint Sprain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.1 View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11.1 View
Diabetes Meelitus SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11.1 View
Bone Neoplasm Malignant SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 11.1 View
Pituitary Tumor Benign SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 11.1 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
Hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 11.1 View
Appendicitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
Alanine Aminotransferase Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.1 View
Aspartate Aminotransferase Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.1 View
Osteoarthritis SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Sedation SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.1 View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.1 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 11.1 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 11.1 View
Tension SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 11.1 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
Aptyalism SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.1 View
Weight Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.1 View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.1 View
Dizziness Postural SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.1 View