Study: NCT01744977

Adverse event: Cardiac Related Hospitalization or Visit
Serious: yes
Organ System: Cardiac disorders
Notes: Includes: chest pain, MI, heart failure, hospitalization including surgery
Frequency: 9 affected / 120 at risk

Adverse event: Hospitalization-Infection
Serious: yes
Organ System: Infections and infestations
Notes: Sepsis related to kidney failure
Frequency: 1 affected / 120 at risk

Adverse event: Hospitalization- Respiratory
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Includes: pneumonia, lung disease
Frequency: 1 affected / 120 at risk

Adverse event: Hospitalization-Stroke
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 120 at risk

Adverse event: Musculoskeletal Surgery
Serious: yes
Organ System: Surgical and medical procedures
Notes: Knee Arthroplasty Surgery
Frequency: 2 affected / 120 at risk

Adverse event: Death unrelated to study protocol
Serious: yes
Organ System: General disorders
Notes: Unrelated pt deaths (cancer, CHF complications, not specified)
Frequency: 2 affected / 120 at risk

Adverse event: Hospitalization-Gastrointestinal
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Events include: small bowel obstruction and diverticulitis
Frequency: 1 affected / 120 at risk

Adverse event: Hospitalization-General
Serious: yes
Organ System: General disorders
Notes: Events include: Re-occurring treatment for prior dx (spinal injury), Multi-factorial hospitalization causes, MVA events, \& Unspecified causes
Frequency: 2 affected / 120 at risk

Adverse event: Hospitalization-Infection
Serious: yes
Organ System: Infections and infestations
Notes: Events include: Fever during radiation treatment, Febrile Neutropenia, Cellulitis, Fainting, Food poisoning, UTI
Frequency: 3 affected / 120 at risk

Adverse event: Hospitalization-Musculoskeletal
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Events include: Assault, Spinal surgery rehab, Fractures,
Frequency: 2 affected / 120 at risk

Adverse event: Hospitalizations-Psychiatric
Serious: yes
Organ System: Psychiatric disorders
Notes: Events include: Psychiatric events (due to HIPAA can not collect/provide details)
Frequency: 3 affected / 120 at risk

Adverse event: Hospitalization- Renal
Serious: yes
Organ System: Renal and urinary disorders
Notes: Events include: Renal failure, hematuria, Acute kidney disease
Frequency: 3 affected / 120 at risk

Adverse event: Hospitaliztion- Respiratory
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Events include: Pneumonia, Lung Mass, Impaired gas exchange, pulmonary embolism
Frequency: 3 affected / 120 at risk

Adverse event: Surgery during Hospitaliztion
Serious: yes
Organ System: Surgical and medical procedures
Notes: Event include:renal biopsy, amputation (and revision), coronary angiograph, lesion, lung removal, spinal cord bx, spinal surgery, carotid endarterectomy, tendon repair, tumor, nephrectomy, back surgery, hip arthroplasty, cath, appendix, etc
Frequency: 11 affected / 120 at risk

Adverse event: Hospitalization- Vascular
Serious: yes
Organ System: Vascular disorders
Notes: Events include: Stroke, Blood clot
Frequency: 2 affected / 120 at risk

Adverse event: Renal blockage- ER Visit
Serious: yes
Organ System: Renal and urinary disorders
Notes: Events include: Blocked catheter,
Frequency: 1 affected / 120 at risk

Adverse event: Bronchitis/COPD- ER Visit
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Pt came to ER for SOB via EMS.
Frequency: 1 affected / 120 at risk

Adverse event: Scheduled Outpatient Surgery
Serious: yes
Organ System: General disorders
Notes: Events include: laryngoscopy with lesion removal, thyroid nodule
Frequency: 2 affected / 120 at risk

Adverse event: Scheduled Outpatient Surgery- Renal
Serious: yes
Organ System: Renal and urinary disorders
Notes: Events include: PCN placement for ureteral obstruction, bladder tumor resection,
Frequency: 1 affected / 120 at risk

Adverse event: Bee Sting- Emergency Room Visit
Serious: yes
Organ System: General disorders
Notes: Bee sting
Frequency: 1 affected / 120 at risk

Adverse event: Bleeding- Emergency Room Visit
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: Heavy bleeding accompanied by lightheadedness
Frequency: 1 affected / 120 at risk

Adverse event: Cardiac Related Hospitalization or Visit
Serious: yes
Organ System: Cardiac disorders
Notes: Includes: chest pain, MI, heart failure, hospitalization including surgery
Frequency: 5 affected / 120 at risk

Adverse event: Bowel Obstruction- Hospitalization
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Hospitalization
Frequency: 1 affected / 120 at risk

Adverse event: General Hospitalization
Serious: yes
Organ System: General disorders
Notes: chemotherapy complication
Frequency: 1 affected / 120 at risk

Adverse event: Hospitalization-Renal
Serious: yes
Organ System: Renal and urinary disorders
Notes: Increased Cr, acute renal failure
Frequency: 1 affected / 120 at risk

Adverse event: Hospitalization- Respiratory
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Includes: pneumonia, lung disease
Frequency: 2 affected / 120 at risk

Adverse event: Death unrelated to study protocol
Serious: yes
Organ System: General disorders
Notes: Unrelated pt deaths (cancer, CHF complications, not specified)
Frequency: 3 affected / 120 at risk

Adverse event: Hospitalization-Gastrointestinal
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Events include: small bowel obstruction and diverticulitis
Frequency: 1 affected / 120 at risk

Adverse event: Hospitalization-General
Serious: yes
Organ System: General disorders
Notes: Events include: Re-occurring treatment for prior dx (spinal injury), Multi-factorial hospitalization causes, MVA events, \& Unspecified causes
Frequency: 3 affected / 120 at risk

Adverse event: Hospitalization-Infection
Serious: yes
Organ System: Infections and infestations
Notes: Events include: Fever during radiation treatment, Febrile Neutropenia, Cellulitis, Fainting, Food poisoning, UTI
Frequency: 3 affected / 120 at risk

Adverse event: Hospitalization-Musculoskeletal
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Events include: Assault, Spinal surgery rehab, Fractures,
Frequency: 1 affected / 120 at risk

Adverse event: Hospitalization-Neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Events include: Lymphadenopathy sarcoma
Frequency: 1 affected / 120 at risk

Adverse event: Hospitaliztion- Nervous
Serious: yes
Organ System: Nervous system disorders
Notes: Events include: spinal cord injury biopsy
Frequency: 1 affected / 120 at risk

Adverse event: Hospitalizations-Psychiatric
Serious: yes
Organ System: Psychiatric disorders
Notes: Events include: Psychiatric events (due to HIPAA can not collect/provide details)
Frequency: 1 affected / 120 at risk

Adverse event: Hospitalization- Renal
Serious: yes
Organ System: Renal and urinary disorders
Notes: Events include: Renal failure, hematuria, Acute kidney disease
Frequency: 1 affected / 120 at risk

Adverse event: Surgery during Hospitaliztion
Serious: yes
Organ System: Surgical and medical procedures
Notes: Event include:renal biopsy, amputation (and revision), coronary angiograph, lesion, lung removal, spinal cord bx, spinal surgery, carotid endarterectomy, tendon repair, tumor, nephrectomy, back surgery, hip arthroplasty, cath, appendix, etc
Frequency: 9 affected / 120 at risk

Adverse event: Hospitalization- Vascular
Serious: yes
Organ System: Vascular disorders
Notes: Events include: Stroke, Blood clot
Frequency: 1 affected / 120 at risk

Adverse event: Scheduled Outpatient Surgery
Serious: yes
Organ System: General disorders
Notes: Events include: laryngoscopy with lesion removal, thyroid nodule
Frequency: 1 affected / 120 at risk

Adverse event: Planned outpatient surgery- Shoulder
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Rotator cuff repair
Frequency: 1 affected / 120 at risk