Study: NCT00723125

Adverse event: gr 3 Nausea, gr 3 vomiting
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 28 at risk

Adverse event: gr 3 nausea, gr 2 infection with noraml ANC, gr 2 HGB, gr 1 glucose
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 28 at risk

Adverse event: gr 2 non-cardiac chest pain, gr 2 anemia
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 28 at risk

Adverse event: gr 3 infection (normal ANC) (cellulitis & pain in buttock - RT infection), gr 1 epistaxis
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 28 at risk

Adverse event: K gr 4,mental status gr 4, ventricular arrythmia gr 4, pneumonia gr 3
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 28 at risk

Adverse event: gr 2 Pleural effusion
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 28 at risk

Adverse event: cr 2, dehydration2, anemia2, weight loss2, fatigue-1, dysgeusia-2, gastritis-2, anorexia-2
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 28 at risk

Adverse event: White blood cell count
Serious: no
Organ System: Investigations
Frequency: 23 affected / 28 at risk

Adverse event: ANC
Serious: no
Organ System: Investigations
Frequency: 24 affected / 28 at risk

Adverse event: PLT
Serious: no
Organ System: Investigations
Frequency: 25 affected / 28 at risk

Adverse event: HGB
Serious: no
Organ System: Investigations
Frequency: 27 affected / 28 at risk

Adverse event: Infection
Serious: no
Organ System: Investigations
Frequency: 5 affected / 28 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Investigations
Frequency: 4 affected / 28 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 28 at risk

Adverse event: Fatigue
Serious: no
Organ System: Investigations
Frequency: 20 affected / 28 at risk

Adverse event: Rash
Serious: no
Organ System: Investigations
Frequency: 2 affected / 28 at risk

Adverse event: Nausea
Serious: no
Organ System: Investigations
Frequency: 12 affected / 28 at risk

Adverse event: Vomiting
Serious: no
Organ System: Investigations
Frequency: 6 affected / 28 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: Investigations
Frequency: 6 affected / 28 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Investigations
Frequency: 5 affected / 28 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Investigations
Frequency: 9 affected / 28 at risk

Adverse event: Liver function test
Serious: no
Organ System: Investigations
Frequency: 10 affected / 28 at risk

Adverse event: Neurosensory
Serious: no
Organ System: Investigations
Frequency: 3 affected / 28 at risk

Adverse event: Neuromuscular
Serious: no
Organ System: Investigations
Frequency: 4 affected / 28 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Investigations
Frequency: 4 affected / 28 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Investigations
Frequency: 5 affected / 28 at risk

Adverse event: Hypomagnesmia
Serious: no
Organ System: Investigations
Frequency: 12 affected / 28 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Investigations
Frequency: 5 affected / 28 at risk

Adverse event: Alk-Phos abnormality
Serious: no
Organ System: Investigations
Frequency: 4 affected / 28 at risk

Adverse event: epistaxis or bleeding
Serious: no
Organ System: Investigations
Frequency: 13 affected / 28 at risk

Adverse event: HTN
Serious: no
Organ System: Investigations
Frequency: 3 affected / 28 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Investigations
Frequency: 3 affected / 28 at risk

Adverse event: Mucositis gr 3, fever gr 1, fatigue gr 1
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 27 at risk

Adverse event: Acute Kidney Injury gr 2
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 27 at risk

Adverse event: gr 4 GI Bleed (lesion in colon- villious adenoma)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 27 at risk

Adverse event: FN-gr 1 fever, gr 3 ANC (gr 3 infection)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 27 at risk

Adverse event: FN (fever gr1, ANC 3, infection3)- however during hospitalization ANC rose to grade 4
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 27 at risk

Adverse event: gr 4 ANC, gr 2 bleeding hemorrhoid, gr 2 rectal pain, dizziness gr 2
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 27 at risk

Adverse event: left groin abcess- gr 2 1/14/14**amended to grade 3**
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 27 at risk

Adverse event: dehydration gr 3, worsening anemia gr 3, diarrhea gr2, anorexia gr 2, ANC 3
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 27 at risk

Adverse event: White blood cell count
Serious: no
Organ System: Investigations
Frequency: 27 affected / 27 at risk

Adverse event: ANC
Serious: no
Organ System: Investigations
Frequency: 22 affected / 27 at risk

Adverse event: PLT
Serious: no
Organ System: Investigations
Frequency: 20 affected / 27 at risk

Adverse event: HGB
Serious: no
Organ System: Investigations
Frequency: 24 affected / 27 at risk

Adverse event: Infection
Serious: no
Organ System: Investigations
Frequency: 6 affected / 27 at risk

Adverse event: Myalgias
Serious: no
Organ System: Investigations
Frequency: 11 affected / 27 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Investigations
Frequency: 3 affected / 27 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Investigations
Frequency: 22 affected / 27 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 27 at risk

Adverse event: Fatigue
Serious: no
Organ System: Investigations
Frequency: 26 affected / 27 at risk

Adverse event: Nausea
Serious: no
Organ System: Investigations
Frequency: 22 affected / 27 at risk

Adverse event: Vomiting
Serious: no
Organ System: Investigations
Frequency: 9 affected / 27 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: Investigations
Frequency: 16 affected / 27 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Investigations
Frequency: 16 affected / 27 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Investigations
Frequency: 14 affected / 27 at risk

Adverse event: Liver function test
Serious: no
Organ System: Investigations
Frequency: 12 affected / 27 at risk

Adverse event: Neurosensory
Serious: no
Organ System: Investigations
Frequency: 17 affected / 27 at risk

Adverse event: Neuromuscular
Serious: no
Organ System: Investigations
Frequency: 6 affected / 27 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Investigations
Frequency: 5 affected / 27 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Investigations
Frequency: 7 affected / 27 at risk

Adverse event: Hypomagnesmia
Serious: no
Organ System: Investigations
Frequency: 4 affected / 27 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Investigations
Frequency: 12 affected / 27 at risk

Adverse event: Alk-Phos abnormality
Serious: no
Organ System: Investigations
Frequency: 5 affected / 27 at risk

Adverse event: Cough
Serious: no
Organ System: Investigations
Frequency: 7 affected / 27 at risk

Adverse event: epistaxis or bleeding
Serious: no
Organ System: Investigations
Frequency: 24 affected / 27 at risk

Adverse event: Chest Pain/Bradycardia
Serious: no
Organ System: Investigations
Frequency: 2 affected / 27 at risk

Adverse event: HTN
Serious: no
Organ System: Investigations
Frequency: 3 affected / 27 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Investigations
Frequency: 3 affected / 27 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Investigations
Frequency: 3 affected / 27 at risk

Adverse event: Ocular
Serious: no
Organ System: Investigations
Frequency: 13 affected / 27 at risk

Adverse event: gr 3 FN (gr 3 infection, gr 3 ANC), gr 3 mucositis, gr 2 Diarrhea, Gr 2 pain rectal
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 27 at risk

Adverse event: gr 3 periorbital cellulitis associated with chalazia, gr 2 anemia
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 27 at risk

Adverse event: gr 4 ANC
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 27 at risk

Adverse event: anemia 2
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 27 at risk

Adverse event: gr 2 dehydration, gr 2 wt loss, gr 2 anorexia, gr 3 esophagitis, gr 2 mucositis, gr 3 ANC, Gr 4 PLT
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 27 at risk

Adverse event: gr3 FN, gr3 HGB, Gr2 fatigue, gr2 nausea, gr2 anorexia, gr2 dehydration, gr1 fever, gr1 epistaxis
Serious: yes
Organ System: Investigations
Notes: FN-(infection and ANC)
Frequency: 1 affected / 27 at risk

Adverse event: ANC 4, HGB 3, PLT 3
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 27 at risk

Adverse event: weakness gr 4
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 27 at risk

Adverse event: FN gr 3, ANC 3, anemia gr 2, thrombocytopenia gr 3
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 27 at risk

Adverse event: FN gr3, bradycardia gr1, infection gr3, pancytopenia gr3, sore throat gr1, body aches gr1,rigors gr1
Serious: yes
Organ System: Investigations
Notes: with grade 4 HGB and PLT FN (fever gr 3 and ANC 4)
Frequency: 1 affected / 27 at risk

Adverse event: dehydration2, k3, nausea2, anemia2, cpain2, SOB1, FN, vomiting2, PLT 4, mucositis2, fatigue2
Serious: yes
Organ System: Investigations
Notes: FN - febrile neutropenia :(fever (3) and ANC(4))
Frequency: 1 affected / 27 at risk

Adverse event: White blood cell count
Serious: no
Organ System: Investigations
Frequency: 5 affected / 27 at risk

Adverse event: ANC
Serious: no
Organ System: Investigations
Frequency: 4 affected / 27 at risk

Adverse event: PLT
Serious: no
Organ System: Investigations
Frequency: 13 affected / 27 at risk

Adverse event: HGB
Serious: no
Organ System: Investigations
Frequency: 21 affected / 27 at risk

Adverse event: Myalgias
Serious: no
Organ System: Investigations
Frequency: 5 affected / 27 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Investigations
Frequency: 2 affected / 27 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Investigations
Frequency: 5 affected / 27 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 27 at risk

Adverse event: Fatigue
Serious: no
Organ System: Investigations
Frequency: 17 affected / 27 at risk

Adverse event: Nausea
Serious: no
Organ System: Investigations
Frequency: 11 affected / 27 at risk

Adverse event: Vomiting
Serious: no
Organ System: Investigations
Frequency: 3 affected / 27 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Investigations
Frequency: 2 affected / 27 at risk

Adverse event: Liver function test
Serious: no
Organ System: Investigations
Frequency: 7 affected / 27 at risk

Adverse event: Neuromuscular
Serious: no
Organ System: Investigations
Frequency: 2 affected / 27 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Investigations
Frequency: 4 affected / 27 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Investigations
Frequency: 5 affected / 27 at risk

Adverse event: Hypomagnesmia
Serious: no
Organ System: Investigations
Frequency: 10 affected / 27 at risk

Adverse event: Alk-Phos abnormality
Serious: no
Organ System: Investigations
Frequency: 3 affected / 27 at risk

Adverse event: epistaxis or bleeding
Serious: no
Organ System: Investigations
Frequency: 5 affected / 27 at risk

Adverse event: Chest Pain/Bradycardia
Serious: no
Organ System: Investigations
Frequency: 2 affected / 27 at risk

Adverse event: HTN
Serious: no
Organ System: Investigations
Frequency: 3 affected / 27 at risk

Adverse event: FN (fever gr1, ANC 3, infection3)- however during hospitalization ANC rose to grade 4
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 24 at risk

Adverse event: gr 2 odynophagia, gr 2 allergic rxn, gr 2 oral thrush, gr 4 ANC
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 24 at risk

Adverse event: Post Op and Pre-drug- gr 1 fever,gr 2 erythema, gr 2 chills
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 24 at risk

Adverse event: Post op- wound infection gr 2 on DIEP flap
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 24 at risk

Adverse event: FN gr 4 (fever gr 1, ANC 4), cough 2, nasal congestion 2
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 24 at risk

Adverse event: FN (fever gr 1, ANC 4) Anemia 2
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 24 at risk

Adverse event: bleeding from JP drain grade 1
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 24 at risk

Adverse event: FN- fever gr 1, ANC 4
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 24 at risk

Adverse event: FN gr 3 (fever gr 1, ANC gr 3)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 24 at risk

Adverse event: White blood cell count
Serious: no
Organ System: Investigations
Frequency: 8 affected / 24 at risk

Adverse event: ANC
Serious: no
Organ System: Investigations
Frequency: 4 affected / 24 at risk

Adverse event: PLT
Serious: no
Organ System: Investigations
Frequency: 2 affected / 24 at risk

Adverse event: epistaxis or bleeding
Serious: no
Organ System: Investigations
Frequency: 12 affected / 24 at risk

Adverse event: Chest Pain/Bradycardia
Serious: no
Organ System: Investigations
Frequency: 3 affected / 24 at risk

Adverse event: Post surgery: gr 3 infection
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 15 at risk

Adverse event: gr 4 skin breakdown
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 15 at risk

Adverse event: gr 2 pleural effusion
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 15 at risk

Adverse event: grade 1 fever, gr 3 malignant pleural effusion
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 15 at risk

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

Adverse event: epistaxis or bleeding
Serious: no
Organ System: Investigations
Frequency: 2 affected / 15 at risk

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

Adverse event: breast cellulitis gr 3, acute renal injury gr 2, diarrhea gr 1, hemmorrhage GI gr 3
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 21 at risk

Adverse event: Post Reconstruction Surgery- infection left breast gr 3
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 21 at risk

Adverse event: post radiation- gr 3 wound complication would dehiscence
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 21 at risk

Adverse event: gr 2 right arm weakness- motor neuropthay, right shoulder pain- r/o TIA
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 21 at risk

Adverse event: secondary malignancy: bladder cancer potentially related to DDAC
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 21 at risk

Adverse event: Left breast pain gr 2
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 21 at risk

Adverse event: PE gr 4, fever gr 2
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 21 at risk

Adverse event: post op comp breast cellulitis gr3, migraine gr2
Serious: yes
Organ System: Investigations
Notes: Plus:hypocalcemia gr2, hypokalemia gr1, hypomag gr1, anemia gr1, hypophos gr2
Frequency: 1 affected / 21 at risk

Adverse event: related to reconstruction: infection with normal ANC- post complication healing issue (3)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 21 at risk

Adverse event: White blood cell count
Serious: no
Organ System: Investigations
Frequency: 3 affected / 21 at risk

Adverse event: ANC
Serious: no
Organ System: Investigations
Frequency: 2 affected / 21 at risk

Adverse event: Myalgias
Serious: no
Organ System: Investigations
Frequency: 2 affected / 21 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Investigations
Frequency: 1 affected / 21 at risk

Adverse event: Fatigue
Serious: no
Organ System: Investigations
Frequency: 4 affected / 21 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: Investigations
Frequency: 1 affected / 21 at risk

Adverse event: Liver function test
Serious: no
Organ System: Investigations
Frequency: 3 affected / 21 at risk

Adverse event: Hypomagnesmia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 21 at risk

Adverse event: epistaxis or bleeding
Serious: no
Organ System: Investigations
Frequency: 7 affected / 21 at risk

Adverse event: HTN
Serious: no
Organ System: Investigations
Frequency: 7 affected / 21 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Investigations
Frequency: 3 affected / 21 at risk

Adverse event: Hyperbili
Serious: no
Organ System: Investigations
Frequency: 1 affected / 21 at risk