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 @ 7:33 PM
Ignite Modification Date: 2025-12-25 @ 5:15 PM
NCT ID: NCT01789203
Description: None
Frequency Threshold: 5
Time Frame: Adverse events were collected out through 4 months (3 months of study drug administration + 1 month post- administration). Patients were asked during clinic visits to report any potential ciprofloxacin adverse event from a list of common adverse effects. Additional AEs were collected if reported by clinician. Graft loss and patient death were additionally collected out through 1 year
Study: NCT01789203
Study Brief: Ciprofloxacin for Prevention of BK Infection
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 Matching placebo will be administered as two-capsules given once daily for 3 months post-transplant placebo 1 None 18 67 55 67 View
Ciprofloxacin Ciprofloxacin will be administered as two-250 mg capsules, administered once daily for 3 months post-transplant Ciprofloxacin: Patients will be randomized 2:1 active comparator to placebo comparator. 1 None 35 133 108 133 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Ascites SYSTEMATIC_ASSESSMENT General disorders None View
Clostridium difficile SYSTEMATIC_ASSESSMENT Infections and infestations None View
Chest pain SYSTEMATIC_ASSESSMENT General disorders None View
Cytomegalovirus SYSTEMATIC_ASSESSMENT Infections and infestations None View
Dehydration SYSTEMATIC_ASSESSMENT General disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dyspnea SYSTEMATIC_ASSESSMENT General disorders None View
Dysuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Epistaxis SYSTEMATIC_ASSESSMENT General disorders None View
Fever SYSTEMATIC_ASSESSMENT General disorders None View
GI bleed SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hematoma SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Hematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Hyperglycemia SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Hyperkalemia SYSTEMATIC_ASSESSMENT General disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
malignant hypertension SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nephrolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nonfunctinal nephrostomy tube SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Radial nerve palsy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Small bowel obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Urinary leak SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urinary retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Viral syndrome SYSTEMATIC_ASSESSMENT Infections and infestations None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
VTE SYSTEMATIC_ASSESSMENT Vascular disorders None View
Wound infection/complication SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Edema SYSTEMATIC_ASSESSMENT General disorders None View
Headache SYSTEMATIC_ASSESSMENT General disorders None View
Hematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Hypomagnesemia SYSTEMATIC_ASSESSMENT General disorders None View
Insomnia SYSTEMATIC_ASSESSMENT General disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Osteopenia/osteoperosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urinary tract infections SYSTEMATIC_ASSESSMENT Infections and infestations None View
Weight gain SYSTEMATIC_ASSESSMENT General disorders None View