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 @ 3:52 PM
Ignite Modification Date: 2025-12-25 @ 1:58 PM
NCT ID: NCT00183092
Description: None
Frequency Threshold: 2
Time Frame: 1 year
Study: NCT00183092
Study Brief: CJD (Creutzfeldt-Jakob Disease) Quinacrine Study
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 Random Assignment Placebo : 100mg by mouth three times a day, Baseline-Month 2 = random assignment (n=28), Month 2+ = optional continuation of assigned drug (n=1). None None 14 28 9 28 View
Quinacrine Random Assignment Quinacrine: 100mg by mouth three times a day. Baseline-Month 2 = random assignment (n=23), Month 2+ = optional continuation of assigned drug (n=1). None None 13 23 9 23 View
Quinacrine Open-label Quinacrine: Month 2 until death = optional open-label Quinacrine 100mg by mouth three times a day None None 14 24 16 24 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Fall NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Death NON_SYSTEMATIC_ASSESSMENT General disorders None View
Seizure NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Unclassified shaking NON_SYSTEMATIC_ASSESSMENT General disorders None View
Agitation NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Elevated renal function labs SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Post-LP headache NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Post-LP Dizziness NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Hemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Post-LP infection NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Hallucinations NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Agitation NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Elevated Liver Function Tests SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Potential thrombi NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Post-LP complications NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Hallucination NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Pulmonary embolism NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hip Fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Elevated creatine kinase NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Dizziness NON_SYSTEMATIC_ASSESSMENT General disorders None View
Seizure NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fever NON_SYSTEMATIC_ASSESSMENT General disorders None View
Abdominal abscess NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Urinary Tract Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View