Study: NCT00717756

Adverse event: edema gr 3, lethargy gr 2, HGB gr 2, hypotension gr 2
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 40 at risk

Adverse event: vasovagal episode gr3
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 40 at risk

Adverse event: ascites gr3, Liver dysfunction gr 3, fatigue gr 3, dehydration gr 3, vomiting gr 2, constipation gr2
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 40 at risk

Adverse event: bilirubin gr4, ascites gr 3, hyponatremia gr 3, hyperk gr 3
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 40 at risk

Adverse event: non-blistering rash gr 3
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 40 at risk

Adverse event: increased confusion
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 40 at risk

Adverse event: muscle weakness gr3, myelosuppresion gr 3
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 40 at risk

Adverse event: bilirubin gr 3, right upper quad pain gr 2
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 40 at risk

Adverse event: n gr1, v gr1, d gr1, pain abd gr2, pain chest gr2, gastro viral gr2
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 40 at risk

Adverse event: fracture gr 2
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 40 at risk

Adverse event: syncope gr3
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 40 at risk

Adverse event: syncope gr3, enceph gr 5, liver failure gr 5, GI bleed gr 3, death gr 5
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 40 at risk

Adverse event: hepatic enceph gr 3, mood alteration gr 2, mental status change gr 3
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 40 at risk

Adverse event: lower chest pressure
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 40 at risk

Adverse event: dizziness gr 3, dyspnea gr2, tumor pain gr 3, dehydration gr 3, confusion gr 1
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 40 at risk

Adverse event: bronchitis, pleural effusion, dyspnea, lower extrem edema, rash
Serious: yes
Organ System: Investigations
Notes: Labs AEs with SAE: anemia, ammonia, AST, alk phos, sodium, K, chloride, mg, co2, anion gap, albumin, BNP, ca, PLT
Frequency: 1 affected / 40 at risk

Adverse event: fever gr 2, chills gr 2, bilary obstruction gr2, sepsis gr 2
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 40 at risk

Adverse event: expired secondary to disease
Serious: yes
Organ System: Investigations
Frequency: 11 affected / 40 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Investigations
Frequency: 4 affected / 40 at risk

Adverse event: Alopecia
Serious: no
Organ System: Investigations
Frequency: 3 affected / 40 at risk

Adverse event: ALT /AST
Serious: no
Organ System: Investigations
Frequency: 7 affected / 40 at risk

Adverse event: ANC
Serious: no
Organ System: Investigations
Frequency: 6 affected / 40 at risk

Adverse event: Anaemia
Serious: no
Organ System: Investigations
Frequency: 6 affected / 40 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Investigations
Frequency: 4 affected / 40 at risk

Adverse event: Ascites
Serious: no
Organ System: Investigations
Frequency: 2 affected / 40 at risk

Adverse event: Blood calcium
Serious: no
Organ System: Investigations
Frequency: 3 affected / 40 at risk

Adverse event: Constipation
Serious: no
Organ System: Investigations
Frequency: 8 affected / 40 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Investigations
Frequency: 5 affected / 40 at risk

Adverse event: Diverticulitis
Serious: no
Organ System: Investigations
Frequency: 2 affected / 40 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Investigations
Frequency: 3 affected / 40 at risk

Adverse event: Oedema
Serious: no
Organ System: Investigations
Frequency: 4 affected / 40 at risk

Adverse event: Oesophageal stenosis
Serious: no
Organ System: Investigations
Frequency: 2 affected / 40 at risk

Adverse event: Fatigue
Serious: no
Organ System: Investigations
Frequency: 13 affected / 40 at risk

Adverse event: Gastritis
Serious: no
Organ System: Investigations
Frequency: 2 affected / 40 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Investigations
Frequency: 4 affected / 40 at risk

Adverse event: HCT
Serious: no
Organ System: Investigations
Frequency: 4 affected / 40 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Investigations
Frequency: 2 affected / 40 at risk

Adverse event: Hyperbili
Serious: no
Organ System: Investigations
Frequency: 6 affected / 40 at risk

Adverse event: hyperalbumin
Serious: no
Organ System: Investigations
Frequency: 2 affected / 40 at risk

Adverse event: Hypoalbumin
Serious: no
Organ System: Investigations
Frequency: 5 affected / 40 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Investigations
Frequency: 3 affected / 40 at risk

Adverse event: Hypomagnesium
Serious: no
Organ System: Investigations
Frequency: 3 affected / 40 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Investigations
Frequency: 7 affected / 40 at risk

Adverse event: infection-abdomen
Serious: no
Organ System: Investigations
Frequency: 2 affected / 40 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Investigations
Frequency: 3 affected / 40 at risk

Adverse event: Nausea
Serious: no
Organ System: Investigations
Frequency: 5 affected / 40 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Investigations
Frequency: 4 affected / 40 at risk

Adverse event: pain-abdomen
Serious: no
Organ System: Investigations
Frequency: 5 affected / 40 at risk

Adverse event: pain-extremeties
Serious: no
Organ System: Investigations
Frequency: 4 affected / 40 at risk

Adverse event: Pain-general/tumor
Serious: no
Organ System: Investigations
Frequency: 8 affected / 40 at risk

Adverse event: puritis
Serious: no
Organ System: Investigations
Frequency: 5 affected / 40 at risk

Adverse event: Rash
Serious: no
Organ System: Investigations
Frequency: 11 affected / 40 at risk

Adverse event: thrmbocytopenia
Serious: no
Organ System: Investigations
Frequency: 12 affected / 40 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Investigations
Frequency: 3 affected / 40 at risk

Adverse event: White blood cell count
Serious: no
Organ System: Investigations
Frequency: 8 affected / 40 at risk