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 @ 4:31 PM
Ignite Modification Date: 2025-12-25 @ 2:23 PM
NCT ID: NCT00674466
Description: None
Frequency Threshold: 5
Time Frame: 16 weeks
Study: NCT00674466
Study Brief: A Study to Evaluate the Efficacy and Safety of CJC-1134-PC in Patients With Type 2 Diabetes Who Are Currently on Metformin Monotherapy
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 Twice-a-week placebo for CJC-1134-PC Placebo: twice-a-week 0 None 1 29 20 29 View
1.5 mg or 2.0 mg CJC-1134-PC Twice-a-week dose of 1.5 mg CJC-1134-PC for 4 weeks, then once-a-week dose of 2.0 mg CJC-1134-PC plus mid-week dosing of placebo 1.5 mg or 2.0 mg CJC-1134-PC: twice-a-week 0 None 0 30 19 30 View
1.5 mg CJC-1134-PC Twice-a-week dose of 1.5 mg CJC-1134-PC 1.5 mg CJC-1134-PC: twice-a-week 0 None 1 30 18 30 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Eye infection staphylococcal SYSTEMATIC_ASSESSMENT Infections and infestations None View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastroesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Toothache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Injection site reaction SYSTEMATIC_ASSESSMENT General disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Edema peripheral SYSTEMATIC_ASSESSMENT General disorders None View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Skin laceration SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Muscle spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Sinus congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View