Study: NCT00040365

Adverse event: Proctitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: abdominal pain/cramping
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Common Toxicity Criteria (CTC) v2.0 Adverse Event (AE)
Frequency: 4 affected / 30 at risk

Adverse event: allergic reaction/hypersensitivity
Serious: no
Organ System: Immune system disorders
Notes: CTCv2.0 AE
Frequency: 1 affected / 30 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: CTCv2.0 AE
Frequency: 1 affected / 30 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: CTCv2.0 AE
Frequency: 5 affected / 30 at risk

Adverse event: bladder
Serious: no
Organ System: Renal and urinary disorders
Notes: CTCv2.0 AE
Frequency: 1 affected / 30 at risk

Adverse event: cardiac-ischemia/infarction
Serious: no
Organ System: Cardiac disorders
Notes: CTCv2.0 AE
Frequency: 1 affected / 30 at risk

Adverse event: Chest pain
Serious: no
Organ System: Nervous system disorders
Notes: CTCv2.0 AE
Frequency: 1 affected / 30 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Notes: CTCv2.0 AE
Frequency: 1 affected / 30 at risk

Adverse event: CN. VI
Serious: no
Organ System: Nervous system disorders
Notes: CTCv2.0 AE
Frequency: 1 affected / 30 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: CTCv2.0 AE
Frequency: 1 affected / 30 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: CTCv2.0 AE
Frequency: 2 affected / 30 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: CTCv2.0 AE
Frequency: 25 affected / 30 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Notes: CTCv2.0 AE
Frequency: 1 affected / 30 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: CTCv2.0 AE
Frequency: 1 affected / 30 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: CTCv2.0 AE
Frequency: 4 affected / 30 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Notes: CTCv2.0 AE
Frequency: 16 affected / 30 at risk

Adverse event: Erectile dysfunction
Serious: no
Organ System: Reproductive system and breast disorders
Notes: CTCv2.0 AE
Frequency: 3 affected / 30 at risk

Adverse event: erectile impotence
Serious: no
Organ System: Reproductive system and breast disorders
Notes: CTCv2.0 AE
Frequency: 18 affected / 30 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: CTCv2.0 AE
Frequency: 3 affected / 30 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: CTCv2.0 AE
Frequency: 27 affected / 30 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Notes: CTCv2.0 AE
Frequency: 9 affected / 30 at risk

Adverse event: Genitourinary
Serious: no
Organ System: Renal and urinary disorders
Notes: CTCv2.0 AE
Frequency: 1 affected / 30 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: CTCv2.0 AE
Frequency: 1 affected / 30 at risk

Adverse event: Haematochezia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: CTCv2.0 AE
Frequency: 6 affected / 30 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Notes: CTCv2.0 AE
Frequency: 4 affected / 30 at risk

Adverse event: Hip Pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: CTCv2.0 AE
Frequency: 1 affected / 30 at risk

Adverse event: Hot flush
Serious: no
Organ System: Endocrine disorders
Notes: CTCv2.0 AE
Frequency: 1 affected / 30 at risk

Adverse event: hot flashes/flushes
Serious: no
Organ System: Endocrine disorders
Notes: CTCv2.0 AE
Frequency: 5 affected / 30 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Notes: CTCv2.0 AE
Frequency: 1 affected / 30 at risk

Adverse event: Incontinence
Serious: no
Organ System: Renal and urinary disorders
Notes: CTCv2.0 AE
Frequency: 23 affected / 30 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: CTCv2.0 AE
Frequency: 1 affected / 30 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Notes: CTCv2.0 AE
Frequency: 2 affected / 30 at risk

Adverse event: Knee
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: CTCv2.0 AE
Frequency: 1 affected / 30 at risk

Adverse event: libido
Serious: no
Organ System: Reproductive system and breast disorders
Notes: CTCv2.0 AE
Frequency: 6 affected / 30 at risk

Adverse event: mood alteration- depression
Serious: no
Organ System: Nervous system disorders
Notes: CTCv2.0 AE
Frequency: 22 affected / 30 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: Gastrointestinal disorders
Notes: CTCv2.0 AE
Frequency: 20 affected / 30 at risk

Adverse event: mucous membrane
Serious: no
Organ System: Gastrointestinal disorders
Notes: CTCv2.0 AE
Frequency: 19 affected / 30 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: CTCv2.0 AE
Frequency: 3 affected / 30 at risk

Adverse event: neck/shoulder
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: CTCv2.0 AE
Frequency: 1 affected / 30 at risk

Adverse event: neuropathy-sensory
Serious: no
Organ System: Nervous system disorders
Notes: CTCv2.0 AE
Frequency: 3 affected / 30 at risk

Adverse event: orgasmic dysfunction
Serious: no
Organ System: Reproductive system and breast disorders
Notes: CTCv2.0 AE
Frequency: 1 affected / 30 at risk

Adverse event: other-weak stream (ibuprofen)
Serious: no
Organ System: Renal and urinary disorders
Notes: CTCv2.0 AE
Frequency: 20 affected / 30 at risk

Adverse event: other- back (d/t bulge disc (L1-L2P)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: CTCv2.0 AE
Frequency: 2 affected / 30 at risk

Adverse event: other-body hair loss
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: CTCv2.0 AE
Frequency: 1 affected / 30 at risk

Adverse event: other-breast tenderness
Serious: no
Organ System: Reproductive system and breast disorders
Notes: CTCv2.0 AE
Frequency: 3 affected / 30 at risk

Adverse event: other-burning (burning with urination; burning in penis; Cipro)
Serious: no
Organ System: Renal and urinary disorders
Notes: CTCv2.0 AE
Frequency: 1 affected / 30 at risk

Adverse event: other-edema (mucosal edema; redness)
Serious: no
Organ System: Gastrointestinal disorders
Notes: CTCv2.0 AE
Frequency: 1 affected / 30 at risk

Adverse event: other-ejaculate (Cipro)
Serious: no
Organ System: Reproductive system and breast disorders
Notes: CTCv2.0 AE
Frequency: 3 affected / 30 at risk

Adverse event: other-knee injury (orthopedic evaluation)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: CTCv2.0 AE
Frequency: 1 affected / 30 at risk

Adverse event: other-L arm
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: CTCv2.0 AE
Frequency: 1 affected / 30 at risk

Adverse event: other-L side
Serious: no
Organ System: Nervous system disorders
Notes: CTCv2.0 AE
Frequency: 1 affected / 30 at risk

Adverse event: other-local swelling (r/t IL-2 injection)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: CTCv2.0 AE
Frequency: 1 affected / 30 at risk

Adverse event: other-low back (d/t osteophytes (MRI); Celebrex; Advil)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: CTCv2.0 AE
Frequency: 1 affected / 30 at risk

Adverse event: other-mucositis (erythema)
Serious: no
Organ System: Gastrointestinal disorders
Notes: CTCv2.0 AE
Frequency: 2 affected / 30 at risk

Adverse event: other-pressure (incr pressure urinary stream)
Serious: no
Organ System: Renal and urinary disorders
Notes: CTCv2.0 AE
Frequency: 1 affected / 30 at risk

Adverse event: other-rectal spasm
Serious: no
Organ System: Gastrointestinal disorders
Notes: CTCv2.0 AE
Frequency: 1 affected / 30 at risk

Adverse event: other-tenesmus
Serious: no
Organ System: Gastrointestinal disorders
Notes: CTCv2.0 AE
Frequency: 2 affected / 30 at risk

Adverse event: other-tubular adenoma (colonoscopy/bx 12/19/05)
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: CTCv2.0 AE
Frequency: 1 affected / 30 at risk

Adverse event: Pain: Headaches
Serious: no
Organ System: Nervous system disorders
Notes: CTCv2.0 AE
Frequency: 1 affected / 30 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Notes: CTCv2.0 AE
Frequency: 1 affected / 30 at risk

Adverse event: Proctitis
Serious: no
Organ System: Gastrointestinal disorders
Notes: CTCv2.0 AE
Frequency: 29 affected / 30 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: CTCv2.0 AE
Frequency: 8 affected / 30 at risk

Adverse event: radiation dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: CTCv2.0 AE
Frequency: 1 affected / 30 at risk

Adverse event: sm/ lg bowel
Serious: no
Organ System: Gastrointestinal disorders
Notes: CTCv2.0 AE
Frequency: 28 affected / 30 at risk

Adverse event: Syncope
Serious: no
Organ System: Nervous system disorders
Notes: CTCv2.0 AE
Frequency: 1 affected / 30 at risk

Adverse event: Taste disorder
Serious: no
Organ System: Gastrointestinal disorders
Notes: CTCv2.0 AE
Frequency: 1 affected / 30 at risk

Adverse event: thrombosis/embolism
Serious: no
Organ System: Vascular disorders
Notes: CTCv2.0 AE
Frequency: 1 affected / 30 at risk

Adverse event: Tremor-arms
Serious: no
Organ System: Nervous system disorders
Notes: CTCv2.0 AE
Frequency: 1 affected / 30 at risk

Adverse event: urinary frequency/urgency
Serious: no
Organ System: Renal and urinary disorders
Notes: CTCv2.0 AE
Frequency: 27 affected / 30 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Notes: CTCv2.0 AE
Frequency: 21 affected / 30 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: CTCv2.0 AE
Frequency: 1 affected / 30 at risk

Adverse event: Weight increased
Serious: no
Organ System: General disorders
Notes: CTCv2.0 AE
Frequency: 13 affected / 30 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Notes: CTCv2.0 AE
Frequency: 11 affected / 30 at risk

Adverse event: Bladder
Serious: no
Organ System: Renal and urinary disorders
Notes: Radiation Therapy Oncology Group (RTOG) Adverse Event (AE)
Frequency: 1 affected / 30 at risk

Adverse event: Mucous membrane
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: RTOG AE
Frequency: 19 affected / 30 at risk

Adverse event: Small/large bowel
Serious: no
Organ System: Gastrointestinal disorders
Notes: RTOG AE
Frequency: 28 affected / 30 at risk