Study: NCT02042872

Adverse event: General Surgery
Serious: yes
Organ System: Surgical and medical procedures
Notes: During the inpatient stay, 1 participant had gallbladder surgery, 1 participant had a suprapubic catheter inserted, 1 participant had flap surgery for a decubitus ulcer, and 1 participant had an intrathecal baclofen pump inserted.
Frequency: 3 affected / 8 at risk

Adverse event: Bowel Impaction
Serious: yes
Organ System: Gastrointestinal disorders
Notes: One participant was admitted to an acute care facility for bowel impaction
Frequency: 1 affected / 8 at risk

Adverse event: Decubitus ulcer
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: One participant was admitted to an acute care facility for symptoms resulting from a stage IV decubitus ulcer and treatment with hyperbaric chamber therapy.
Frequency: 1 affected / 8 at risk

Adverse event: Spinal headache
Serious: yes
Organ System: Nervous system disorders
Notes: One participant was admitted to the hospital for severe migraine headaches. This was the result of leaking cerebral spinal fluid when spinal anesthesia punctured the dura mater during a Botulinum toxin procedure.
Frequency: 1 affected / 8 at risk

Adverse event: Deep Venous Thrombosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Patient was admitted to hospital for lower extremity pain that was diagnosed as a deep venous thrombosis.
Frequency: 1 affected / 8 at risk

Adverse event: Acute Febrile Reaction
Serious: no
Organ System: General disorders
Notes: In the zoledronic acid arm, 4 participants experienced low grade fevers while 2 participants experienced moderate to severe fevers.
Frequency: 6 affected / 8 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: All subjects in the zoledronic acid arm experienced mild to severe myalgia (muscle pain).
Frequency: 8 affected / 8 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Vomiting was noted in 6 of the 8 participants in the zoledronic acid arm.
Frequency: 6 affected / 8 at risk

Adverse event: Lethargy
Serious: no
Organ System: General disorders
Notes: All participants in the zoledronic acid arm experienced mild to severe lethargy (drowsiness).
Frequency: 8 affected / 8 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Hypocalcemia (low blood calcium) occurred in 1 participant and resolved within one week without any specific therapy instituted.
Frequency: 1 affected / 8 at risk

Adverse event: General Surgery
Serious: yes
Organ System: Surgical and medical procedures
Notes: During the inpatient stay, 1 participant had gallbladder surgery, 1 participant had a suprapubic catheter inserted, 1 participant had flap surgery for a decubitus ulcer, and 1 participant had an intrathecal baclofen pump inserted.
Frequency: 1 affected / 13 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Renal and urinary disorders
Notes: Two participants were admitted to an acute care facility for sever pain that after a complete work up was diagnosed as a urinary tract infection.
Frequency: 1 affected / 13 at risk

Adverse event: Deep Venous Thrombosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Patient was admitted to hospital for lower extremity pain that was diagnosed as a deep venous thrombosis.
Frequency: 1 affected / 13 at risk