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 @ 9:48 PM
Ignite Modification Date: 2025-12-25 @ 7:27 PM
NCT ID: NCT00667732
Description: All participants who received at least one dose of treatment during appropriate period
Frequency Threshold: 5
Time Frame: Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
Study: NCT00667732
Study Brief: How Glargine Insulin, Oral Diabetes Medications and Exenatide May Improve Blood Sugar Control and Weight Gain in Type 2 Diabetics
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Run-In Group All participants took exenatide twice daily in addition to their Metformin dose. None None 0 38 21 38 View
Exenatide Open-Label (Previous Exenatide) Participants who were in the Exenatide Arm during randomization who received open label: exenatide : 5mcg twice a day, increasing to 10mcg twice a day for 24 weeks metformin: continued at same dose participant entered study on. Lantus Insulin: titrated per protocol depending on blood sugar level None None 0 14 11 14 View
Exenatide Randomization Group After run-in participants were randomized to exenatide. exenatide : 5mcg twice a day, increasing to 10mcg twice a day for 24 weeks metformin: continued at same dose participant entered study on. Lantus Insulin: titrated per protocol depending on blood sugar levels None None 0 17 15 17 View
Placebo Randomization Period After run-in participants were randomized to placebo. placebo : 5mcg twice a day, increased to 10mcg twice a day for 24 weeks metformin: continued at same dose participant entered study on. Lantus Insulin: titrated per protocol depending on blood sugar levels None None 0 17 10 17 View
Exenatide Open-Label (Previous Placebo) Participants who were in the Placebo Arm during randomization who received open label: exenatide : 5mcg twice a day, increasing to 10mcg twice a day for 24 weeks metformin: continued at same dose participant entered study on. Lantus Insulin: titrated per protocol depending on blood sugar level None None 0 17 12 17 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea None Gastrointestinal disorders None View
Vomiting None Gastrointestinal disorders None View
Stomach ache, upset None Gastrointestinal disorders None View
Heartburn, reflux None Gastrointestinal disorders None View
diarrhea, loose stools None Gastrointestinal disorders None View
Upper Respiratory Infection None Infections and infestations None View
Headache None Nervous system disorders None View
Bloating None Gastrointestinal disorders None View
Abdominal Pain None Gastrointestinal disorders None View
Hiatal Hernia None Gastrointestinal disorders None View
Constipation None Gastrointestinal disorders None View
Sour Taste None Gastrointestinal disorders None View
Dental Work None Gastrointestinal disorders None View
Gastroenteritis, stomach flu None Gastrointestinal disorders None View
Diverticulitis None Gastrointestinal disorders None View
Hemorrhoids None Gastrointestinal disorders None View
Allergies None Immune system disorders None View
Sinusitis None Infections and infestations None View
Strep Throat None Infections and infestations None View
Bronchitis None Infections and infestations None View
Ear Infection None Infections and infestations None View
Left wrist sprain None Injury, poisoning and procedural complications None View
Left 5th toe fracture None Injury, poisoning and procedural complications None View
Fall with bruised arm, leg None Injury, poisoning and procedural complications None View
Right Ankle Pain None Musculoskeletal and connective tissue disorders None View
Right thumb pain None Musculoskeletal and connective tissue disorders None View
Left foot pain None Musculoskeletal and connective tissue disorders None View
Right and left shoulder pain None Musculoskeletal and connective tissue disorders None View
Leg cramps None Musculoskeletal and connective tissue disorders None View
Right ankle swelling None Musculoskeletal and connective tissue disorders None View
left toe swelling (gout) None Musculoskeletal and connective tissue disorders None View
Dizziness None Nervous system disorders None View
Syncope None Nervous system disorders None View
Peripheral Neuropathy None Nervous system disorders None View
Left wrist pain and numbness None Nervous system disorders None View
Depression None Psychiatric disorders None View
Urinary tract infection None Renal and urinary disorders None View
Elevated Creatinine None Renal and urinary disorders None View
Cough None Respiratory, thoracic and mediastinal disorders None View
Nasal Congestion None Respiratory, thoracic and mediastinal disorders None View
Lost voice None Respiratory, thoracic and mediastinal disorders None View
Injection site redness, itching None Skin and subcutaneous tissue disorders None View
Left wrist pigmentation None Skin and subcutaneous tissue disorders None View
Hypertension None Vascular disorders None View
Conjunctival hemorrhage None Eye disorders None View
Dry Eyes None Eye disorders None View
Toothache None Gastrointestinal disorders None View
Decreased energy None General disorders None View
Cold/flu None Infections and infestations None View
Sore Throat None Infections and infestations None View
Ear Infection None Infections and infestations None View
Lymph node enlargement, cervical None Infections and infestations None View
Paronychial infection, finger None Infections and infestations None View
Cold sore, lip None Infections and infestations None View
Ankle sprain None Injury, poisoning and procedural complications None View
Motor vehicle accident with facial laceration None Injury, poisoning and procedural complications None View
Hyperglycemia None Metabolism and nutrition disorders None View
Rib Pain None Musculoskeletal and connective tissue disorders None View
Knee Pain None Musculoskeletal and connective tissue disorders None View
Hip Pain None Musculoskeletal and connective tissue disorders None View
Foot Pain None Musculoskeletal and connective tissue disorders None View
Arthritis, leg None Musculoskeletal and connective tissue disorders None View
Aching elbows None Musculoskeletal and connective tissue disorders None View
Bell's Palsy None Nervous system disorders None View
Numbness, arms, hands None Nervous system disorders None View
Carpal Tunnel syndrome None Nervous system disorders None View
Ulnar neuropathy None Nervous system disorders None View
Hypoglycemia None Endocrine disorders None View
Fall with leg contusion None Injury, poisoning and procedural complications None View