Study: NCT00702962

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Leukocytes (total WBC)
Frequency: 1 affected / 1 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Neutrophils/granulocytes (ANC/AGC)
Frequency: 1 affected / 1 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Platelets, low
Frequency: 1 affected / 1 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Notes: Decreased appetite
Frequency: 1 affected / 1 at risk

Adverse event: Thrombophlebitis
Serious: yes
Organ System: Vascular disorders
Notes: Phlebitis (including superficial thrombosis); Hospitalization for Thrombophlebitis
Frequency: 1 affected / 3 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Leukocytes (total WBC)
Frequency: 3 affected / 3 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Neutrophils/granulocytes (ANC/AGC)
Frequency: 3 affected / 3 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Platelets, low
Frequency: 2 affected / 3 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Nausea
Frequency: 3 affected / 3 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Fatigue (asthenia, lethargy, malaise)
Frequency: 3 affected / 3 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Hemoglobin, Low
Frequency: 3 affected / 3 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Glucose, serum-high (hyperglycemia)
Frequency: 1 affected / 3 at risk

Adverse event: Flushing
Serious: no
Organ System: General disorders
Notes: Flushing
Frequency: 1 affected / 3 at risk

Adverse event: Alkaline phosphatase, elevated
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Alkaline phosphatase
Frequency: 3 affected / 3 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Notes: Insomnia
Frequency: 2 affected / 3 at risk

Adverse event: Vulvovaginal candidiasis
Serious: no
Organ System: Infections and infestations
Notes: Infection with unknown ANC, vaginal
Frequency: 1 affected / 3 at risk

Adverse event: Alanine aminotransferase (ALT) elevation
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: ALT, SGPT (serum glutamic pyruvic transaminase)
Frequency: 1 affected / 3 at risk

Adverse event: Hyperbilirubinaemia
Serious: no
Organ System: Hepatobiliary disorders
Notes: Bilirubin (hyperbilirubinemia)
Frequency: 1 affected / 3 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Calcium, serum-low (hypocalcemia)
Frequency: 1 affected / 3 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Productive cough
Frequency: 1 affected / 3 at risk

Adverse event: Erythema, skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Erythema to lips and leg patch
Frequency: 2 affected / 3 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 3 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Notes: Dry mouth/salivary gland (xerostomia)
Frequency: 1 affected / 3 at risk

Adverse event: Fever without neutropenia
Serious: no
Organ System: General disorders
Notes: Fever (in the absence of neutropenia, where neutropenia is defined as ANC \<1.0 x 10e9/L)
Frequency: 1 affected / 3 at risk

Adverse event: Hiccoughs
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Hiccoughs (hiccups, singultus)
Frequency: 1 affected / 3 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infection with unknown ANC - Skin - cellulitis
Frequency: 1 affected / 3 at risk

Adverse event: Hypermagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Magnesium, serum-high (hypermagnesemia)
Frequency: 1 affected / 3 at risk

Adverse event: Restlessness with irritibility
Serious: no
Organ System: Nervous system disorders
Notes: Mood alteration - Agitation
Frequency: 1 affected / 3 at risk

Adverse event: Anxiety
Serious: no
Organ System: Nervous system disorders
Notes: Mood alteration - anxiety
Frequency: 1 affected / 3 at risk

Adverse event: Abnormal dreams
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 3 at risk

Adverse event: Back pain
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 3 at risk

Adverse event: Pain, extremity/limb
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 3 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 3 at risk

Adverse event: Pain - Throat/pharynx/larynx
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Potassium, serum-low (hypokalemia)
Frequency: 1 affected / 3 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Sodium, serum-low (hyponatremia)
Frequency: 1 affected / 3 at risk

Adverse event: Ulceration, vaginal
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Vaginal ulceration lesion
Frequency: 1 affected / 3 at risk