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 @ 10:35 PM
Ignite Modification Date: 2025-12-25 @ 8:07 PM
NCT ID: NCT01972035
Description: None
Frequency Threshold: 2
Time Frame: 1 year following intervention
Study: NCT01972035
Study Brief: ValGanciclovir Versus ValAcyclovir for Viral Prophylaxis in Kidney Transplantation
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
ValAcyclovir Kidney recipients who give informed consent will be randomly assigned to receive ValA or ValG in a 1:1 ratio. Duration of therapy is 3-12 months depending on risk and age of recipient. Dosing is based on glomerular filtration rate. Valacyclovir: Experimental Arm 0 None 52 66 64 66 View
ValGanciclovir Kidney recipients who give informed consent will be randomly assigned to receive ValG or ValA in a 1:1 ratio. Duration of therapy is 3-12 months depending on risk and age of recipient. Dosing is based on glomerular filtration rate. Valganciclovir: Standard of care 0 None 50 71 70 71 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Acute Kidney Problems NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Ascites NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Bacterial Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Biopsy NON_SYSTEMATIC_ASSESSMENT Investigations None View
Blood sugar concerns NON_SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Breathing concerns NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dehydration NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Donor source antibodies NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
Elevated Creatinine NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Fever NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
G Tube Concerns NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Heart concerns NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hematuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Hyperkalemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyponatremia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Mental Concerns NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Severe Pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Thrombosis NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Upper Respiratory Infection NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
Urination Concerns NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urinary Tract Infection NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Other NON_SYSTEMATIC_ASSESSMENT General disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache NON_SYSTEMATIC_ASSESSMENT General disorders None View
Abdominal Pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Emesis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
Alopecia NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
Anemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Abnormal LFTs NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Thrombocytopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Peripheral neuropathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View