Study: NCT01671488

Adverse event: fever (1), hypotension(2)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 10 at risk

Adverse event: fever (1), hypotension(2) Hypokalemia (3)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 10 at risk

Adverse event: weakness (3), decreased appetite (2), GI bleed(3). Anemia(3)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 10 at risk

Adverse event: Nausea (3), dehydration (3), anal mucositis (3), enterocolitis (2)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 10 at risk

Adverse event: Nausea(3),dehydration(3),anal mucositis(3),
Serious: yes
Organ System: Investigations
Notes: enterocolitis(2),colitis(2),perianal pain(3), diarrhea(2),weakness(2),Anemia(2)
Frequency: 1 affected / 10 at risk

Adverse event: Expired unknown reason (5)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 10 at risk

Adverse event: seizure (3), catastrophic pulmonary or cardiac event or massive CVA (5)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 10 at risk

Adverse event: PLT(4), diarrhea (2), ANC (3), fever (1)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 10 at risk

Adverse event: Diarrhea (3), dehydration(3), wt loss (2), back pain (2), fatigue (2),
Serious: yes
Organ System: Investigations
Notes: hypokalemia (3), HGB(3), PLT (2), Glucose (1), Hyponatremia (1), albumin(1), hypocalcemia (1), WBC (2), Lymph (4)
Frequency: 1 affected / 10 at risk

Adverse event: Diarrhea (2), wt loss (2) , back pain (1), fatigue (2),
Serious: yes
Organ System: Investigations
Notes: HGB(2), PLT (3), Glucose-hyperglycemia (1), , albumin(2), hypocalcemia (2), WBC (2), Lymph (2), fever (2)
Frequency: 1 affected / 10 at risk

Adverse event: fever (1) headache (1)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 10 at risk

Adverse event: Fever(1*)febrile neutropenia(3*)ANC(3*)WBC (4*), PLT (4*)
Serious: yes
Organ System: Investigations
Notes: Anemia (3\*)cellulitis (2\*)acute kidney injury(2\*)creatinine(2\*)mucositis(1\*)Lymph(4\*)
Frequency: 1 affected / 10 at risk

Adverse event: ANC (4*)WBC(4*)PLT(3*)Anemia (3*)cellulitis (2*),mucositis (1*)Lymph (4*),
Serious: yes
Organ System: Investigations
Notes: thromboembolic event(2\*),left lower leg edema(1\*)
Frequency: 1 affected / 10 at risk

Adverse event: chest pain (1*), shortness of breath (3*), lightheadedness (1*)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 10 at risk

Adverse event: Rectal bleeding (3*), Anemia (2*) , ANC(3*) , PLT(4*) , Fever (1*)
Serious: yes
Organ System: Investigations
Notes: Dermatitis radiation (3\*) , pain rectal (2\*)
Frequency: 1 affected / 10 at risk

Adverse event: Rectal bleeding (3*)Anemia (3*)ANC(4*)PLT(4*)Fever (1*)
Serious: yes
Organ System: Investigations
Notes: Dermatitis radiation (3\*)pain rectal (2\*)
Frequency: 1 affected / 10 at risk

Adverse event: allergies
Serious: no
Organ System: Investigations
Frequency: 2 affected / 10 at risk

Adverse event: Alanine aminotransferase
Serious: no
Organ System: Investigations
Frequency: 2 affected / 10 at risk

Adverse event: Anal inflammation
Serious: no
Organ System: Investigations
Frequency: 1 affected / 10 at risk

Adverse event: ANC
Serious: no
Organ System: Investigations
Frequency: 2 affected / 10 at risk

Adverse event: Anaemia
Serious: no
Organ System: Investigations
Frequency: 3 affected / 10 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Investigations
Frequency: 2 affected / 10 at risk

Adverse event: Anxiety
Serious: no
Organ System: Investigations
Frequency: 1 affected / 10 at risk

Adverse event: Activated partial thromboplastin time
Serious: no
Organ System: Investigations
Frequency: 1 affected / 10 at risk

Adverse event: Aspartate aminotransferase
Serious: no
Organ System: Investigations
Frequency: 2 affected / 10 at risk

Adverse event: chills/rigors
Serious: no
Organ System: Investigations
Frequency: 8 affected / 10 at risk

Adverse event: Constipation
Serious: no
Organ System: Investigations
Frequency: 2 affected / 10 at risk

Adverse event: Confusional state
Serious: no
Organ System: Investigations
Frequency: 1 affected / 10 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Investigations
Frequency: 1 affected / 10 at risk

Adverse event: Dehydration
Serious: no
Organ System: Investigations
Frequency: 2 affected / 10 at risk

Adverse event: Depression
Serious: no
Organ System: Investigations
Frequency: 2 affected / 10 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Investigations
Frequency: 5 affected / 10 at risk

Adverse event: Frequent stools (non-diarrhea)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 10 at risk

Adverse event: Anal incontinence
Serious: no
Organ System: Investigations
Frequency: 2 affected / 10 at risk

Adverse event: Dizziness
Serious: no
Organ System: Investigations
Frequency: 3 affected / 10 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 10 at risk

Adverse event: Dyspnea/SOB
Serious: no
Organ System: Investigations
Frequency: 3 affected / 10 at risk

Adverse event: Oedema
Serious: no
Organ System: Investigations
Frequency: 2 affected / 10 at risk

Adverse event: erythoderma/erythema
Serious: no
Organ System: Investigations
Frequency: 1 affected / 10 at risk

Adverse event: Dry skin
Serious: no
Organ System: Investigations
Frequency: 1 affected / 10 at risk

Adverse event: ejaculatory dysfunction
Serious: no
Organ System: Investigations
Frequency: 1 affected / 10 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Investigations
Frequency: 1 affected / 10 at risk

Adverse event: Fatigue
Serious: no
Organ System: Investigations
Frequency: 6 affected / 10 at risk

Adverse event: Pyrexia
Serious: no
Organ System: Investigations
Frequency: 3 affected / 10 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: Investigations
Frequency: 1 affected / 10 at risk

Adverse event: Gastritis
Serious: no
Organ System: Investigations
Frequency: 1 affected / 10 at risk

Adverse event: GI bleed/bloody diarrhea/rectal bleed
Serious: no
Organ System: Investigations
Frequency: 1 affected / 10 at risk

Adverse event: H/A
Serious: no
Organ System: Investigations
Frequency: 5 affected / 10 at risk

Adverse event: Haematuria
Serious: no
Organ System: Investigations
Frequency: 2 affected / 10 at risk

Adverse event: Hot flush
Serious: no
Organ System: Investigations
Frequency: 3 affected / 10 at risk

Adverse event: Hyperpigmentation
Serious: no
Organ System: Investigations
Frequency: 2 affected / 10 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 10 at risk

Adverse event: Hypoalbumin
Serious: no
Organ System: Investigations
Frequency: 4 affected / 10 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Investigations
Frequency: 2 affected / 10 at risk

Adverse event: hypohydrosis
Serious: no
Organ System: Investigations
Frequency: 1 affected / 10 at risk

Adverse event: HypoK
Serious: no
Organ System: Investigations
Frequency: 5 affected / 10 at risk

Adverse event: HypoMG
Serious: no
Organ System: Investigations
Frequency: 2 affected / 10 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Investigations
Frequency: 8 affected / 10 at risk

Adverse event: Hypotension
Serious: no
Organ System: Investigations
Frequency: 1 affected / 10 at risk

Adverse event: Hypertension
Serious: no
Organ System: Investigations
Frequency: 5 affected / 10 at risk

Adverse event: International normalised ratio
Serious: no
Organ System: Investigations
Frequency: 1 affected / 10 at risk

Adverse event: Dizziness
Serious: no
Organ System: Investigations
Frequency: 1 affected / 10 at risk

Adverse event: lymphocyte decrease
Serious: no
Organ System: Investigations
Frequency: 7 affected / 10 at risk

Adverse event: Migraine
Serious: no
Organ System: Investigations
Frequency: 1 affected / 10 at risk

Adverse event: mucositis/mouth sores
Serious: no
Organ System: Investigations
Frequency: 8 affected / 10 at risk

Adverse event: Myalgia
Serious: no
Organ System: Investigations
Frequency: 2 affected / 10 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Investigations
Frequency: 2 affected / 10 at risk

Adverse event: Nausea
Serious: no
Organ System: Investigations
Frequency: 7 affected / 10 at risk

Adverse event: pain-abdomen
Serious: no
Organ System: Investigations
Frequency: 4 affected / 10 at risk

Adverse event: pain/back and neck
Serious: no
Organ System: Investigations
Frequency: 3 affected / 10 at risk

Adverse event: pain secondary to abcess/infection
Serious: no
Organ System: Investigations
Frequency: 1 affected / 10 at risk

Adverse event: pain-epigastric
Serious: no
Organ System: Investigations
Frequency: 1 affected / 10 at risk

Adverse event: pain-general
Serious: no
Organ System: Investigations
Frequency: 1 affected / 10 at risk

Adverse event: pain-joints
Serious: no
Organ System: Investigations
Frequency: 1 affected / 10 at risk

Adverse event: pain-leg
Serious: no
Organ System: Investigations
Frequency: 2 affected / 10 at risk

Adverse event: rectal pain/perianal pain
Serious: no
Organ System: Investigations
Frequency: 5 affected / 10 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Investigations
Frequency: 2 affected / 10 at risk

Adverse event: PLT
Serious: no
Organ System: Investigations
Frequency: 5 affected / 10 at risk

Adverse event: Radiation Dermatitis
Serious: no
Organ System: Investigations
Frequency: 4 affected / 10 at risk

Adverse event: Rash
Serious: no
Organ System: Investigations
Frequency: 1 affected / 10 at risk

Adverse event: skin ulceration/Groin sore
Serious: no
Organ System: Investigations
Frequency: 3 affected / 10 at risk

Adverse event: infection (cellulitis/small intestine, abscess, UTI, vaginal)
Serious: no
Organ System: Investigations
Frequency: 3 affected / 10 at risk

Adverse event: social circumstances
Serious: no
Organ System: Investigations
Frequency: 1 affected / 10 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Investigations
Frequency: 1 affected / 10 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 10 at risk

Adverse event: Tooth infection
Serious: no
Organ System: Investigations
Frequency: 1 affected / 10 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Investigations
Frequency: 1 affected / 10 at risk

Adverse event: urinary pain/dysuria
Serious: no
Organ System: Investigations
Frequency: 3 affected / 10 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Investigations
Frequency: 1 affected / 10 at risk

Adverse event: vomitng
Serious: no
Organ System: Investigations
Frequency: 3 affected / 10 at risk

Adverse event: White blood cell count
Serious: no
Organ System: Investigations
Frequency: 6 affected / 10 at risk

Adverse event: Asthenia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 10 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 10 at risk