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: 2025-12-26 @ 1:19 PM
Ignite Modification Date: 2025-12-26 @ 1:19 PM
NCT ID: NCT00675506
Description: None
Frequency Threshold: 5
Time Frame: Safety visits occurred at 2 weeks, 1, 3, 6 and 9 months at which time fasting glucose and IGF-1 were monitored.
Study: NCT00675506
Study Brief: Effectiveness of Growth Hormone Releasing Hormone in Reducing Abdominal Fat in People Who Are Obese
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
TH9507 Participants received treatment with growth hormone releasing hormone 1-44 (TH9507). Growth hormone releasing hormone (GHRH) 1-44 : 2-mg sub-cutaneous abdominal injections once daily for 12 months None None 0 31 28 31 View
Placebo Participants received treatment with placebo medication. Placebo: 2-mg sub-cutaneous abdominal injections once daily for 12 months None None 0 29 26 29 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Injection site bruising SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Injection-site bleeding SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Injection-site pain SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Tingling/ Paresthesia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Peripheral edema SYSTEMATIC_ASSESSMENT Vascular disorders None View
Injection site puritis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Injection site reaction SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Injection site erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Atypical chest pain SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Dermatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fatigue SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Fungal infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Gastroenteritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastroesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Mechanical injury SYSTEMATIC_ASSESSMENT General disorders None View
Musculoskeletal injury SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Tendonitis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Toothache SYSTEMATIC_ASSESSMENT General disorders None View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View