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 @ 1:35 PM
Ignite Modification Date: 2025-12-25 @ 12:35 PM
NCT ID: NCT00878995
Description: None
Frequency Threshold: 0
Time Frame: 7 weeks
Study: NCT00878995
Study Brief: Testosterone for Treating Cachexia in Patients With Squamous Cell Carcinoma
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Arm I: Standard of Care Therapy + Placebo Testosterone Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks. Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone 0 None 6 12 6 12 View
Arm II: Standard of Care Therapy + Testosterone Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks. Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate 0 None 6 12 3 12 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anemia Requiring Tranfusion None Blood and lymphatic system disorders None View
Duodenal Ulcer None Gastrointestinal disorders None View
Cerebrovascular Accident None Vascular disorders None View
Anaphylactic shock None General disorders None View
Pneumonia None Infections and infestations None View
Deep Vein Thrombosis None Vascular disorders None View
Sycope None General disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dysphagia None General disorders None View
Fever None Infections and infestations None View
Neutropenic Fever None Infections and infestations None View
Urinary Tract Infection None Renal and urinary disorders None View
Thrombocytosis None Blood and lymphatic system disorders None View
Altered Mental State None Psychiatric disorders None View
Hyponatremia None Blood and lymphatic system disorders None View
Vesicovaginal Fistula None Reproductive system and breast disorders None View
Metastatic Bowel Obstruction None Gastrointestinal disorders None View