Study: NCT01744340

Adverse event: S b(4), pleural effusion(4), Dyspnea(4), asp(4), lung inf (4), resp acidosis(4)
Serious: yes
Organ System: Investigations
Notes: Shortness of breath (4), left pleural effusion (4) , Dyspnea (4), aspiration (4), lung infection (4), resp acidosis(4)
Frequency: 1 affected / 8 at risk

Adverse event: Acute respiratory failure (5)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 8 at risk

Adverse event: Dyspnea(2), K(3) , MG(2) , ANC(3), Nausea(2), Vomitting(2)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 8 at risk

Adverse event: Edema(3), dysphyagia(3), hemolytic Anemia(3), PLT(4), calcium(1),WBC(1) , lymph(3)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 8 at risk

Adverse event: Hemorragic shock(5), HGB/Anemia(3), Chloride(1) , CO2(1) , AST(2), ALT(2) , PT(1)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 8 at risk

Adverse event: COPDdyspnea(2),neutr(3),sepsis(4),anemia(2),Leuk(3),Lymph (3), Hypergly(2),Hypoca(2), Hypokal(1)
Serious: yes
Organ System: Investigations
Notes: COPD exasp dyspnea (2), neutropenia(3), sepsis(4), anemia (2), Leukopenia(3),Lymphocyte decrease(3), Hyperglycemia(2),Hypocalemia(2), Hypokalemia(1)
Frequency: 1 affected / 8 at risk

Adverse event: Dyspnea(1), Sepsis(4), Anemia(2), Lymphocyte decrease (3), Hypocalcemia(2)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 8 at risk

Adverse event: Feb neut(3), neut(4),anemia(3), leuk(3),hypona(3), lymph(3) , CR(1), Ca(2), K(1), Gluc(1), MG(2)
Serious: yes
Organ System: Investigations
Notes: Febrile neutropenia(3), neutropenia (4),anemia(3), leukopenia(3),hyponatremia(3) , lymphocyte count(3) , CR(1), Calcium(2), K (1), Gluc(1), MG(2)
Frequency: 1 affected / 8 at risk

Adverse event: Feb Neut(res).Neut(0),An(1),Leuk(0),Hypona(1),Lymph(1),CR(0),Ca(1),K(0),Gluc(0),MG(1),URI(2)O Muc(3)
Serious: yes
Organ System: Investigations
Notes: Febrile Neutropenia (resolved). Neutropenia(0), Anemia(1), Leukopenia(0), Hyponatremia(1), Lymphocyte count(1), CR(0), Calcium(1), K(0), Gluc(0), MG(1),URI(2) , Oral Mucositis(3)
Frequency: 1 affected / 8 at risk

Adverse event: Respiratory Infection (5)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 8 at risk

Adverse event: Dyspnea(2), Febrile Neutropenia(3)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 8 at risk

Adverse event: Dyspnea(2), Productive cough(2), Wheezing(3)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 8 at risk

Adverse event: Dys(1),PrCo(0),Whez(0),Resp(4),An(3),HGB(3),Leuk(1),Lymph(3),ALB(2),CA(2),K(3),MG(2),PHOS(4),GLU(2)
Serious: yes
Organ System: Investigations
Notes: Dyspnea (1), Productive Cough (0), Wheezing (0), Respiratory failure (4), Anorexia (3), HGB(3), Leukopenia(1), Lymph(3), HypoALB(2), CA(2), K(3), MG(2), PHOS(4), GLU(2)
Frequency: 1 affected / 8 at risk

Adverse event: Blood albumin
Serious: no
Organ System: Investigations
Frequency: 7 affected / 8 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Investigations
Frequency: 1 affected / 8 at risk

Adverse event: Alanine aminotransferase
Serious: no
Organ System: Investigations
Frequency: 2 affected / 8 at risk

Adverse event: Alopecia
Serious: no
Organ System: Investigations
Frequency: 2 affected / 8 at risk

Adverse event: Absolute Neutrafil Count
Serious: no
Organ System: Investigations
Frequency: 1 affected / 8 at risk

Adverse event: anemia/HGB/Hemolytic anemia
Serious: no
Organ System: Investigations
Frequency: 5 affected / 8 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Investigations
Frequency: 3 affected / 8 at risk

Adverse event: Aspartate aminotransferase
Serious: no
Organ System: Investigations
Frequency: 2 affected / 8 at risk

Adverse event: arterial blood gas
Serious: no
Organ System: Investigations
Frequency: 1 affected / 8 at risk

Adverse event: bleed-urination
Serious: no
Organ System: Investigations
Frequency: 1 affected / 8 at risk

Adverse event: Blood calcium
Serious: no
Organ System: Investigations
Frequency: 2 affected / 8 at risk

Adverse event: Chills
Serious: no
Organ System: Investigations
Frequency: 2 affected / 8 at risk

Adverse event: Cough/Productive cough
Serious: no
Organ System: Investigations
Frequency: 2 affected / 8 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Investigations
Frequency: 1 affected / 8 at risk

Adverse event: Carbon dioxide
Serious: no
Organ System: Investigations
Frequency: 1 affected / 8 at risk

Adverse event: Blood chloride
Serious: no
Organ System: Investigations
Frequency: 1 affected / 8 at risk

Adverse event: Dehydration
Serious: no
Organ System: Investigations
Frequency: 2 affected / 8 at risk

Adverse event: Depression
Serious: no
Organ System: Investigations
Frequency: 1 affected / 8 at risk

Adverse event: Dizziness
Serious: no
Organ System: Investigations
Frequency: 3 affected / 8 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Investigations
Frequency: 2 affected / 8 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 8 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Investigations
Frequency: 2 affected / 8 at risk

Adverse event: EGFR
Serious: no
Organ System: Investigations
Frequency: 1 affected / 8 at risk

Adverse event: erythema (periorbital, ear,facial flushing)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 8 at risk

Adverse event: Fatigue
Serious: no
Organ System: Investigations
Frequency: 7 affected / 8 at risk

Adverse event: Pyrexia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 8 at risk

Adverse event: Blood glucose
Serious: no
Organ System: Investigations
Frequency: 2 affected / 8 at risk

Adverse event: H/A
Serious: no
Organ System: Investigations
Frequency: 2 affected / 8 at risk

Adverse event: Haemoptysis
Serious: no
Organ System: Investigations
Frequency: 1 affected / 8 at risk

Adverse event: Hypotension
Serious: no
Organ System: Investigations
Frequency: 2 affected / 8 at risk

Adverse event: Infection
Serious: no
Organ System: Investigations
Notes: (eye, lung, mucosal, skin, parasitic, cellulitis g-tube, sepsis, Upper respiratory, thrush )
Frequency: 1 affected / 8 at risk

Adverse event: Insomnia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 8 at risk

Adverse event: Blood potassium
Serious: no
Organ System: Investigations
Frequency: 5 affected / 8 at risk

Adverse event: Lymphopenia/Lymphocytes
Serious: no
Organ System: Investigations
Frequency: 3 affected / 8 at risk

Adverse event: m/a (myalgia), weakness
Serious: no
Organ System: Investigations
Frequency: 4 affected / 8 at risk

Adverse event: Blood magnesium
Serious: no
Organ System: Investigations
Frequency: 3 affected / 8 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Investigations
Frequency: 1 affected / 8 at risk

Adverse event: Mucositis, tongue and general
Serious: no
Organ System: Investigations
Frequency: 4 affected / 8 at risk

Adverse event: Blood sodium
Serious: no
Organ System: Investigations
Frequency: 7 affected / 8 at risk

Adverse event: Nausea
Serious: no
Organ System: Investigations
Frequency: 3 affected / 8 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Investigations
Frequency: 3 affected / 8 at risk

Adverse event: pain (general, abd,back,rib, chest, jaw, mouth,throat, hand, neck, head)
Serious: no
Organ System: Investigations
Frequency: 5 affected / 8 at risk

Adverse event: Pericardial effusion
Serious: no
Organ System: Investigations
Frequency: 1 affected / 8 at risk

Adverse event: PT lab
Serious: no
Organ System: Investigations
Frequency: 1 affected / 8 at risk

Adverse event: Rash, acneform, pistula
Serious: no
Organ System: Investigations
Frequency: 5 affected / 8 at risk

Adverse event: Trismus
Serious: no
Organ System: Investigations
Frequency: 1 affected / 8 at risk

Adverse event: Troponin
Serious: no
Organ System: Investigations
Frequency: 1 affected / 8 at risk

Adverse event: vomitting
Serious: no
Organ System: Investigations
Frequency: 3 affected / 8 at risk

Adverse event: White Blood Cells/leukopenia
Serious: no
Organ System: Investigations
Frequency: 3 affected / 8 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 8 at risk

Adverse event: Blood phosphorus
Serious: no
Organ System: Investigations
Frequency: 3 affected / 8 at risk

Adverse event: Sleep disorder
Serious: no
Organ System: Investigations
Frequency: 1 affected / 8 at risk

Adverse event: Chest discomfort
Serious: no
Organ System: Investigations
Frequency: 1 affected / 8 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 8 at risk

Adverse event: Delirium
Serious: no
Organ System: Investigations
Frequency: 1 affected / 8 at risk

Adverse event: Blindness
Serious: no
Organ System: Investigations
Frequency: 1 affected / 8 at risk

Adverse event: Na(3), confusion(1), Fatigue(3), constipation(2), anorexia(3)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 15 at risk

Adverse event: Blood albumin
Serious: no
Organ System: Investigations
Frequency: 7 affected / 15 at risk

Adverse event: ALK
Serious: no
Organ System: Investigations
Frequency: 2 affected / 15 at risk

Adverse event: Alanine aminotransferase
Serious: no
Organ System: Investigations
Frequency: 5 affected / 15 at risk

Adverse event: Alopecia
Serious: no
Organ System: Investigations
Frequency: 2 affected / 15 at risk

Adverse event: Absolute Neutrafil Count
Serious: no
Organ System: Investigations
Frequency: 6 affected / 15 at risk

Adverse event: anemia/HGB/Hemolytic anemia
Serious: no
Organ System: Investigations
Frequency: 7 affected / 15 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Investigations
Frequency: 2 affected / 15 at risk

Adverse event: Anxiety
Serious: no
Organ System: Investigations
Frequency: 1 affected / 15 at risk

Adverse event: Aspartate aminotransferase
Serious: no
Organ System: Investigations
Frequency: 4 affected / 15 at risk

Adverse event: Blood bilirubin
Serious: no
Organ System: Investigations
Frequency: 2 affected / 15 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Investigations
Frequency: 1 affected / 15 at risk

Adverse event: bloat/dyspepsia
Serious: no
Organ System: Investigations
Frequency: 2 affected / 15 at risk

Adverse event: Blood calcium
Serious: no
Organ System: Investigations
Frequency: 1 affected / 15 at risk

Adverse event: Chills
Serious: no
Organ System: Investigations
Frequency: 1 affected / 15 at risk

Adverse event: Constipation
Serious: no
Organ System: Investigations
Frequency: 3 affected / 15 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Investigations
Frequency: 1 affected / 15 at risk

Adverse event: Dehydration
Serious: no
Organ System: Investigations
Frequency: 1 affected / 15 at risk

Adverse event: Depression
Serious: no
Organ System: Investigations
Frequency: 1 affected / 15 at risk

Adverse event: Dizziness
Serious: no
Organ System: Investigations
Frequency: 1 affected / 15 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Investigations
Frequency: 2 affected / 15 at risk

Adverse event: dry skin/pruritis/itching
Serious: no
Organ System: Investigations
Frequency: 3 affected / 15 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 15 at risk

Adverse event: erythema (periorbital, ear,facial flushing)
Serious: no
Organ System: Investigations
Frequency: 2 affected / 15 at risk

Adverse event: Fatigue
Serious: no
Organ System: Investigations
Frequency: 9 affected / 15 at risk

Adverse event: Pyrexia
Serious: no
Organ System: Investigations
Frequency: 2 affected / 15 at risk

Adverse event: H/A
Serious: no
Organ System: Investigations
Frequency: 4 affected / 15 at risk

Adverse event: hypersensitivity rxn
Serious: no
Organ System: Investigations
Frequency: 2 affected / 15 at risk

Adverse event: Hypotension
Serious: no
Organ System: Investigations
Frequency: 1 affected / 15 at risk

Adverse event: Infection
Serious: no
Organ System: Investigations
Notes: (eye, lung, mucosal, skin, parasitic, cellulitis g-tube, sepsis, Upper respiratory, thrush )
Frequency: 4 affected / 15 at risk

Adverse event: Irritability
Serious: no
Organ System: Investigations
Frequency: 1 affected / 15 at risk

Adverse event: Insomnia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 15 at risk

Adverse event: Blood potassium
Serious: no
Organ System: Investigations
Frequency: 7 affected / 15 at risk

Adverse event: Lymphopenia/Lymphocytes
Serious: no
Organ System: Investigations
Frequency: 4 affected / 15 at risk

Adverse event: Blood magnesium
Serious: no
Organ System: Investigations
Frequency: 1 affected / 15 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Investigations
Frequency: 1 affected / 15 at risk

Adverse event: Mucositis, tongue and general
Serious: no
Organ System: Investigations
Frequency: 2 affected / 15 at risk

Adverse event: Blood sodium
Serious: no
Organ System: Investigations
Frequency: 3 affected / 15 at risk

Adverse event: Nausea
Serious: no
Organ System: Investigations
Frequency: 4 affected / 15 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Investigations
Frequency: 3 affected / 15 at risk

Adverse event: sores mouth/lips
Serious: no
Organ System: Investigations
Frequency: 1 affected / 15 at risk

Adverse event: pain (general, abd,back,rib, chest, jaw, mouth,throat, hand, neck, head)
Serious: no
Organ System: Investigations
Frequency: 4 affected / 15 at risk

Adverse event: Rash, acneform, pistula
Serious: no
Organ System: Investigations
Frequency: 7 affected / 15 at risk

Adverse event: rectal bleed/GI hemorrhage
Serious: no
Organ System: Investigations
Frequency: 2 affected / 15 at risk

Adverse event: Shortness Of Breath/dyspnea
Serious: no
Organ System: Investigations
Frequency: 1 affected / 15 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 15 at risk

Adverse event: vomitting
Serious: no
Organ System: Investigations
Frequency: 2 affected / 15 at risk

Adverse event: watery eyes
Serious: no
Organ System: Investigations
Frequency: 1 affected / 15 at risk

Adverse event: White Blood Cells/leukopenia
Serious: no
Organ System: Investigations
Frequency: 9 affected / 15 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 15 at risk

Adverse event: Deep vein thrombosis
Serious: no
Organ System: Investigations
Frequency: 1 affected / 15 at risk