Study: NCT00473265

Adverse event: Infection at bone biopsy site
Serious: yes
Organ System: Infections and infestations
Notes: secondary to participation in study but unrelated to study drug
Frequency: 1 affected / 63 at risk

Adverse event: Right Kidney mass
Serious: yes
Organ System: Renal and urinary disorders
Notes: unlikely to be related to study participation
Frequency: 1 affected / 68 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: categorized as an SAE because it involved hospitalization. unrelated to study participation
Frequency: 2 affected / 68 at risk

Adverse event: pancreatitis, accute
Serious: yes
Organ System: Gastrointestinal disorders
Notes: not related to study participation
Frequency: 1 affected / 68 at risk

Adverse event: ampullary mass
Serious: yes
Organ System: Hepatobiliary disorders
Notes: unrelated to study participation
Frequency: 1 affected / 68 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: categorized as a Serious Adverse Event because it involved hospitalization. unrelated to study participation
Frequency: 1 affected / 68 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Notes: categorized as an SAE because it involved hospitalization unlikely to be related to study participation
Frequency: 1 affected / 68 at risk

Adverse event: Concussion
Serious: yes
Organ System: Nervous system disorders
Notes: concussion secondary to car accident categorized as an SAE because it involved hospitalization unrelated to study participation
Frequency: 1 affected / 68 at risk

Adverse event: damage to surgical site of recent hernia repair
Serious: yes
Organ System: Surgical and medical procedures
Notes: patient fell and damaged the surgical site of a recent hernia repair categorized as an SAE because it involved hospitalization unrelated to study participation
Frequency: 1 affected / 68 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: patient hospitalized with dehydration unrelated to study participation
Frequency: 1 affected / 68 at risk

Adverse event: Cyst removal
Serious: yes
Organ System: Surgical and medical procedures
Notes: unrelated to study participation
Frequency: 1 affected / 68 at risk

Adverse event: symptomatic hypocalcemia
Serious: yes
Organ System: Endocrine disorders
Notes: though hypocalcemia is an anticipated syndrome of hypoparathyroidism, this event resulted in hospitalization

unrelated to study participation
Frequency: 4 affected / 68 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: categorized as a SAE because it involved hospitalization unrelated to study participation
Frequency: 2 affected / 68 at risk

Adverse event: Laryngospasm
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: categorized as an SAE because it involved hospitalization unrelated to study participation
Frequency: 1 affected / 68 at risk

Adverse event: Fainted
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Due to GERD
Frequency: 1 affected / 68 at risk

Adverse event: L Oophorectomy
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 68 at risk

Adverse event: Elective surgery
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 68 at risk

Adverse event: Anxiety/Irritabilty/Stress
Serious: no
Organ System: Psychiatric disorders
Frequency: 20 affected / 68 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 47 affected / 68 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Rash locations vary from patient to patient, areas reported were face and cheeks, arms and legs and coccyx areas.
Frequency: 5 affected / 68 at risk

Adverse event: Bruising at injection site
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 68 at risk

Adverse event: Chest pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 68 at risk

Adverse event: Cold/Flu Virus/Symptoms
Serious: no
Organ System: Infections and infestations
Notes: This adverse event refers to patients who had experienced either cold and flu virus's or symptoms
Frequency: 28 affected / 68 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 68 at risk

Adverse event: Decrease in Urination
Serious: no
Organ System: Renal and urinary disorders
Frequency: 7 affected / 68 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 11 affected / 68 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 68 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 21 affected / 68 at risk

Adverse event: Fatigue
Serious: no
Organ System: Endocrine disorders
Frequency: 23 affected / 68 at risk

Adverse event: Headache/Migraine
Serious: no
Organ System: Nervous system disorders
Frequency: 32 affected / 68 at risk

Adverse event: Temperature Sensitivity
Serious: no
Organ System: Endocrine disorders
Frequency: 10 affected / 68 at risk

Adverse event: Hypercalcaemia
Serious: no
Organ System: Endocrine disorders
Frequency: 5 affected / 68 at risk

Adverse event: Hypertension
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 68 at risk

Adverse event: Increased Urination
Serious: no
Organ System: Renal and urinary disorders
Frequency: 20 affected / 68 at risk

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 16 affected / 68 at risk

Adverse event: Musculoskeletal Irritability
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 41 affected / 68 at risk

Adverse event: Weight Fluctuations
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 14 affected / 68 at risk

Adverse event: Vomitting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 68 at risk

Adverse event: Thirst
Serious: no
Organ System: Renal and urinary disorders
Frequency: 14 affected / 68 at risk

Adverse event: Gastrointestinal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 68 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 34 affected / 68 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 10 affected / 68 at risk

Adverse event: Confusion\Disorientation
Serious: no
Organ System: Psychiatric disorders
Frequency: 11 affected / 68 at risk

Adverse event: Bone Fracture
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 68 at risk

Adverse event: Body Swelling
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 68 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 68 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 68 at risk

Adverse event: Arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 7 affected / 68 at risk

Adverse event: Cysts
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 10 affected / 68 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 68 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 29 affected / 68 at risk

Adverse event: Kidney Stone/Kidney Pain
Serious: no
Organ System: Renal and urinary disorders
Frequency: 8 affected / 68 at risk

Adverse event: Opthalmological Irritability/Visual Impairment
Serious: no
Organ System: Eye disorders
Frequency: 11 affected / 68 at risk

Adverse event: Hypocalcemic Symptoms
Serious: no
Organ System: Endocrine disorders
Frequency: 6 affected / 68 at risk