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 @ 4:50 AM
Ignite Modification Date: 2025-12-26 @ 3:51 AM
NCT ID: NCT00843518
Description: None
Frequency Threshold: 2
Time Frame: None
Study: NCT00843518
Study Brief: Treatment for Aggression and Agitation in Patients With Alzheimer's Disease
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo Post-Study The 30-day period after a participant had taken the last dose of study drug, during which time serious adverse event (SAE) information was collected. None None 0 69 0 69 View
LY451395 Acute Treatment 3 milligram (mg) LY451395 orally twice daily for 12 weeks; may have been reduced to 1 mg if participant was unable to tolerate. None None 5 63 24 63 View
Placebo Acute Treatment Placebo orally twice daily for 12 weeks None None 4 69 24 69 View
LY451395 Washout A 1-week single-blind washout period after the acute period, during which time all randomized participants received placebo. None None 0 42 1 42 View
Placebo Washout A 1-week single-blind washout period after the acute period, during time which all randomized participants received placebo. None None 0 49 2 49 View
LY451395 Post-Study The 30-day period after a participant had taken the last dose of study drug, during which time serious adverse event (SAE) information was collected. None None 1 63 0 63 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.0 View
Diverticulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Diabetes mellitus inadequate control SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 14.0 View
Spinal column stenosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 14.0 View
Haemorrhage intracranial SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.0 View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.0 View
Psychotic disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 14.0 View
Pancreatic pseudocyst SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Transient ischaemic attack SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Eructation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.0 View
Gait disturbance SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.0 View
Gingival infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Vaginal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Face injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 14.0 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 14.0 View
Joint injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 14.0 View
Laceration SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 14.0 View
Blood uric acid increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 14.0 View
Prostatic specific antigen increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 14.0 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 14.0 View
Muscle spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 14.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.0 View
Lethargy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.0 View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 14.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 14.0 View
Hyperhidrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 14.0 View