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: 2025-12-25 @ 4:01 AM
Ignite Modification Date: 2025-12-26 @ 2:54 AM
NCT ID: NCT00752102
Description: None
Frequency Threshold: 5
Time Frame: Adverse events were collected during the time between scans (0-48 weeks)
Study: NCT00752102
Study Brief: Vitamin D and Coronary Calcification Study
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Calcitriol Calcitriol (Rocaltrol®): Subjects taking calcitriol will be started at 0.25 mcg 3x/week and titrated up during the next visit according to PTH levels. If at the 12 week visit, PTH is still not at goal, then calcitriol will be increased to 0.5 mcg 3x/week. 2 None 9 22 18 22 View
Paricalcitol Paricalcitol: Subjects taking paricalcitol will be started at 2 mcg 3x/week and titrated up during the next visit according to PTH levels. If at the 12 week visit, PTH is still not at goal, then paricalcitol will be increased to 4 mcg 3x/week. 1 None 8 22 20 22 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Broken Patella in trip and fall SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Prostate Cancer SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Chest pain due to cocaine use, Congestive Heart Failure and Shortness of breath SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Congestive Heart Failure Exacerbation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hemodialysis access surgery SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Hypercapnic/hypercarbic respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hypercarbic respiratory failure - diastolic dysfunction SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
ER visit for new CPAP mask SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Asthma Exascerbation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
ER visit: fall at home causing back and flank pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Hypercarbic respiratory failure, pulmonary edema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Shortness of Breath SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hospitalization - gastroesophagitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
TIA, confusion SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hypoglycemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Started hemodialysis SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Uncontrolled blood pressure atime of study - took her to ER SYSTEMATIC_ASSESSMENT Cardiac disorders None View
ER Visit - Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
hospitalization for congestive heart failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Dialysis Initiation SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Syncope SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hypotensive Episode SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Prostatectomy and Laparoscopic Lymph node Dissection SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Lower Urinary Tract Symptoms, bladder mass. low grade urothelial carcinoma of bladder, cystoscopy SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Hip dislocation SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Hip Replacement Surgery SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Psychiatric Hospitalizaton SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Congestive Heart Failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Gout flare SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypercalcemia; acute on chronic kideney failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
ED visit - 2nd right toe infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Viral Upper Respiratory Illness SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Muscle Weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Fatigue SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hip Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Hip Dislocation SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fistula Placement SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Broken Patella in trip and fall SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Acute Fever s/p biopsy SYSTEMATIC_ASSESSMENT General disorders None View
Visicoli placement surgery for prostate cancer treatment SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Hand and leg cramps SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Mild hyperkalemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Spontaneous right conjunctival bleed SYSTEMATIC_ASSESSMENT Eye disorders None View
Forgetful, "something wrong with head" SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Left eye cataract extraction SYSTEMATIC_ASSESSMENT Eye disorders None View
Nausea & vomiting, fatigued, shortness of breath SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pain in left leg SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Ankle sprain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Hyperkalemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Uremia Symptoms SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Headaches, fatigue SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hypotension SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Chest pain, possible muscle pull SYSTEMATIC_ASSESSMENT Cardiac disorders None View
gout flare SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Congestive heart failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Weakness, fatigue SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Cataract Surgery SYSTEMATIC_ASSESSMENT Eye disorders None View
Loose stool in AM SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Metal taste SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Kidney pain/ kidney stones SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Gastroparesis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
ER visit (depression exacerbation) SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Swollen Elbow SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Leg Cramps SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Diffuse low back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Edema SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Uremic symptoms SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
AVF placement SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Night Sweats SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Increased thirst SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hospitalization with UTI SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Replacement of nephrostomy tube SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Increased Edema SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Dizzy, diadiaphoretic, fall in anemia clinic SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Severe gout in left foot SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Azotemia, hyperkalemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Back pains SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Anorexia in AM SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Persistent edema SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Nausea, vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hypercalcemia SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Hyperphosphatemia SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Poison ivy SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Cataract extraction & lens implantation SYSTEMATIC_ASSESSMENT Eye disorders None View
knee pain due to fall on bus SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Indeterminate left renal mass SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Nausea & fatigue on passing a stone SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urinary tract infection SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Worsening flank pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Broken right foot SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Feels faint in morning SYSTEMATIC_ASSESSMENT Nervous system disorders None View
ED Visit - CHF, foot pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Problems going to the bathroom SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Chest Pain SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Little headache with unbalance SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Tingling in arms SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Fleeting dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Fistula placement SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Fall at phleobtomy suites SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
LE cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
TDC Cath placement SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Long QT SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Arthritis pain left knee SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Leg cramping and pains SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Broken toe SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Hematoma on knee SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Bronchitis SYSTEMATIC_ASSESSMENT Vascular disorders None View
Nocturnal Cramps SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Right eye cataract extension SYSTEMATIC_ASSESSMENT Eye disorders None View
Left Knee pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
2 episodes chest pain while lying down for bed SYSTEMATIC_ASSESSMENT Cardiac disorders None View
hyperphosphatemia SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Shortness of Breath, Fatigue SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Elevated BP and Edema SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Vomitting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Blunt head injury, hip pain following fall from chair SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Edema & generalized pain left foot SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Gout flare SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View