Study: NCT00061048

Adverse event: CARDIOVASCULAR (GENERAL):: Hypotension
Serious: yes
Organ System: Vascular disorders
Notes: cardiovascular; orthostatic hypotension
Frequency: 1 affected / 29 at risk

Adverse event: CONSTITUTIONAL SYMPTOMS:: Constitutional Symptoms-Other (death)
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 29 at risk

Adverse event: CONSTITUTIONAL SYMPTOMS:: Fatigue (lethargy, malaise, asthenia)
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 29 at risk

Adverse event: CONSTITUTIONAL SYMPTOMS:: Rigors, chills
Serious: yes
Organ System: General disorders
Notes: Infusional reaction
Frequency: 1 affected / 29 at risk

Adverse event: ENDOCRINE:: Endocrine-Other (Endocrine:hyperthyroidism graves disease)
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 29 at risk

Adverse event: GASTROINTESTINAL:: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Infusional reaction
Frequency: 1 affected / 29 at risk

Adverse event: INFECTION/FEBRILE NEUTROPENIA:: Infection without neutropenia
Serious: yes
Organ System: Infections and infestations
Notes: Infection: strongyloidosis
Frequency: 1 affected / 29 at risk

Adverse event: METABOLIC/LABORATORY:: Hypercalcemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 29 at risk

Adverse event: NEUROLOGY:: Neurology-Other (Unresponsiveness)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 29 at risk

Adverse event: OCULAR/VISUAL:: Vision-blurred vision
Serious: yes
Organ System: Eye disorders
Notes: Blurred vision due to uveitis
Frequency: 1 affected / 29 at risk

Adverse event: PULMONARY:: Apnea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 29 at risk

Adverse event: PULMONARY:: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 29 at risk

Adverse event: ALLERGY/IMMUNOLOGY:: Allergic reaction/hypersensitivity (including drug fever)
Serious: no
Organ System: Immune system disorders
Notes: Allergy: infusional reaction
Frequency: 2 affected / 29 at risk

Adverse event: ALLERGY/IMMUNOLOGY:: Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 29 at risk

Adverse event: BLOOD/BONE MARROW:: Hemoglobin
Serious: no
Organ System: Investigations
Notes: Anemia Hemoglobin
Frequency: 20 affected / 29 at risk

Adverse event: BLOOD/BONE MARROW:: Leukocytes (total WBC)
Serious: no
Organ System: Investigations
Notes: Decrease WBC
Frequency: 15 affected / 29 at risk

Adverse event: BLOOD/BONE MARROW:: Lymphopenia
Serious: no
Organ System: Investigations
Notes: Lymphopenia Low lymphocytes
Frequency: 18 affected / 29 at risk

Adverse event: BLOOD/BONE MARROW:: Neutrophils/granulocytes (ANC/AGC)
Serious: no
Organ System: Investigations
Notes: ANC
Frequency: 11 affected / 29 at risk

Adverse event: BLOOD/BONE MARROW:: Platelets
Serious: no
Organ System: Investigations
Notes: Platelets
Frequency: 16 affected / 29 at risk

Adverse event: CARDIOVASCULAR (ARRHYTHMIA):: Cardiovascular/Arrhythmia-Other (irregular heartbeat))
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 29 at risk

Adverse event: CARDIOVASCULAR (ARRHYTHMIA):: Sinus bradycardia
Serious: no
Organ System: Cardiac disorders
Notes: Sinus bradycardia
Frequency: 1 affected / 29 at risk

Adverse event: CARDIOVASCULAR (ARRHYTHMIA):: Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Notes: Sinus tachycardia
Frequency: 5 affected / 29 at risk

Adverse event: CARDIOVASCULAR (ARRHYTHMIA):: Vasovagal episode
Serious: no
Organ System: Cardiac disorders
Notes: Vasovagal episode, Fall
Frequency: 3 affected / 29 at risk

Adverse event: CARDIOVASCULAR (GENERAL):: Edema
Serious: no
Organ System: Cardiac disorders
Notes: Bilat foot, legs, ankle edema Edema: face, forearm, hands, legs Facial swelling Ankles to knees edema Pitting
Frequency: 5 affected / 29 at risk

Adverse event: CARDIOVASCULAR (GENERAL):: Hypertension
Serious: no
Organ System: Vascular disorders
Notes: Hypertension
Frequency: 2 affected / 29 at risk

Adverse event: CARDIOVASCULAR (GENERAL):: Hypotension
Serious: no
Organ System: Vascular disorders
Notes: Hypotension Orthostatic hypotension only after Campath infusions
Frequency: 11 affected / 29 at risk

Adverse event: CARDIOVASCULAR (GENERAL):: Phlebitis (superficial)
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 29 at risk

Adverse event: COAGULATION:: Partial thromboplastin time (PTT)
Serious: no
Organ System: Investigations
Frequency: 4 affected / 29 at risk

Adverse event: COAGULATION:: Prothrombin time (PT)
Serious: no
Organ System: Investigations
Frequency: 2 affected / 29 at risk

Adverse event: CONSTITUTIONAL SYMPTOMS:: Fatigue (lethargy, malaise, asthenia)
Serious: no
Organ System: General disorders
Notes: Fatigue Fatigue (lethargy, malaise, asthenia) Fever
Frequency: 5 affected / 29 at risk

Adverse event: CONSTITUTIONAL SYMPTOMS:: Fever (in the absence of neutropenia, where neutropenia is defined as AGC<
Serious: no
Organ System: General disorders
Notes: Fever Infusional reaction
Frequency: 22 affected / 29 at risk

Adverse event: CONSTITUTIONAL SYMPTOMS:: Rigors, chills
Serious: no
Organ System: General disorders
Notes: Chills Infusional reaction Mild chills Rigors Rigors, chills Chills with Campath Infusional reaction occurred overnight
Frequency: 25 affected / 29 at risk

Adverse event: CONSTITUTIONAL SYMPTOMS:: Sweating (diaphoresis)
Serious: no
Organ System: General disorders
Notes: Sweating (diaphoresis)
Frequency: 1 affected / 29 at risk

Adverse event: CONSTITUTIONAL SYMPTOMS:: Weight gain
Serious: no
Organ System: General disorders
Notes: Ankle edema (increase wt)
Frequency: 1 affected / 29 at risk

Adverse event: CONSTITUTIONAL SYMPTOMS:: Weight loss
Serious: no
Organ System: General disorders
Notes: Weight loss
Frequency: 3 affected / 29 at risk

Adverse event: DERMATOLOGY/SKIN:: Bruising (in absence of grade 3 or 4 thrombocytopenia)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Abdominal bruising, ecchymosis
Frequency: 1 affected / 29 at risk

Adverse event: DERMATOLOGY/SKIN:: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 29 at risk

Adverse event: DERMATOLOGY/SKIN:: Injection site reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Derm: swelling in right arm injection site reaction
Frequency: 1 affected / 29 at risk

Adverse event: DERMATOLOGY/SKIN:: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Itching
Frequency: 8 affected / 29 at risk

Adverse event: DERMATOLOGY/SKIN:: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Skin rash papules (on breast, chest)
Frequency: 8 affected / 29 at risk

Adverse event: DERMATOLOGY/SKIN:: Urticaria (hives, welts, wheals)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Derm: hives, infusion reaction 20 min post Campath On thighs and stomach
Frequency: 11 affected / 29 at risk

Adverse event: ENDOCRINE:: Hypothyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 29 at risk

Adverse event: GASTROINTESTINAL:: Anorexia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 29 at risk

Adverse event: GASTROINTESTINAL:: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 29 at risk

Adverse event: GASTROINTESTINAL:: Diarrhea patients without colostomy
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 29 at risk

Adverse event: GASTROINTESTINAL:: Dyspepsia/heartburn
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 29 at risk

Adverse event: GASTROINTESTINAL:: Dysphagia, esophagitis, odynophagia (painful swallowing)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 29 at risk

Adverse event: GASTROINTESTINAL:: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 29 at risk

Adverse event: GASTROINTESTINAL:: Gastrointestinal-Other (Abdominal distention)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 29 at risk

Adverse event: GASTROINTESTINAL:: Mouth dryness
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 29 at risk

Adverse event: GASTROINTESTINAL:: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Infusional reaction
Frequency: 11 affected / 29 at risk

Adverse event: GASTROINTESTINAL:: Stomatitis/pharyngitis (oral/pharyngeal mucositis)
Serious: no
Organ System: Gastrointestinal disorders
Notes: Tongue and oral mucosa stomatitis
Frequency: 3 affected / 29 at risk

Adverse event: GASTROINTESTINAL:: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Infusional reaction
Frequency: 10 affected / 29 at risk

Adverse event: HEMORRHAGE:: Epistaxis
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Dry due to membrane inflammation
Frequency: 7 affected / 29 at risk

Adverse event: HEMORRHAGE:: Vaginal bleeding
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Spotting
Frequency: 1 affected / 29 at risk

Adverse event: HEPATIC:: Alkaline phosphatase
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 8 affected / 29 at risk

Adverse event: HEPATIC:: Bilirubin
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 5 affected / 29 at risk

Adverse event: HEPATIC:: GGT (Gamma-Glutamyl transpeptidase)
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 29 at risk

Adverse event: HEPATIC:: Hypoalbuminemia
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 14 affected / 29 at risk

Adverse event: HEPATIC:: SGOT (AST) (serum glutamic oxaloacetic transaminase)
Serious: no
Organ System: Hepatobiliary disorders
Notes: Aspartate aminotransferase
Frequency: 12 affected / 29 at risk

Adverse event: HEPATIC:: SGPT (ALT) (serum glutamic pyruvic transaminase)
Serious: no
Organ System: Hepatobiliary disorders
Notes: Alanine aminotransferase
Frequency: 9 affected / 29 at risk

Adverse event: INFECTION/FEBRILE NEUTROPENIA:: Catheter-related infection
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 29 at risk

Adverse event: INFECTION/FEBRILE NEUTROPENIA:: Febrile neutropenia (fever of unknown origin without clinically or m
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Fever
Frequency: 1 affected / 29 at risk

Adverse event: INFECTION/FEBRILE NEUTROPENIA:: Infection (documented clinically or microbiologically) with grade 3
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 29 at risk

Adverse event: INFECTION/FEBRILE NEUTROPENIA:: Infection without neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: CMV CMV(+) Methicillin staphyloccocus aureus (+) Nares (-) Sinus infection (staph aureus) Infection without neutropenia streptococcus Infection: strongyloidosis Left inguinal cellulitis-redness
Frequency: 9 affected / 29 at risk

Adverse event: INFECTION/FEBRILE NEUTROPENIA:: Infection/Febrile Neutropenia-Other (CMV antigenemia)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 29 at risk

Adverse event: LYMPHATICS:: Lymphatics
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Left inguinal swelling
Frequency: 1 affected / 29 at risk

Adverse event: LYMPHATICS:: Lymphatics-Other (Lymphocytes)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 29 at risk

Adverse event: METABOLIC/LABORATORY:: Amylase
Serious: no
Organ System: Investigations
Notes: Amylase
Frequency: 2 affected / 29 at risk

Adverse event: METABOLIC/LABORATORY:: Bicarbonate
Serious: no
Organ System: Investigations
Notes: Bicarbonate
Frequency: 2 affected / 29 at risk

Adverse event: METABOLIC/LABORATORY:: CPK (creatine phosphokinase)
Serious: no
Organ System: Investigations
Frequency: 2 affected / 29 at risk

Adverse event: METABOLIC/LABORATORY:: Hypercalcemia
Serious: no
Organ System: Investigations
Notes: Hypercalcemia
Frequency: 5 affected / 29 at risk

Adverse event: METABOLIC/LABORATORY:: Hypercholesterolemia
Serious: no
Organ System: Investigations
Notes: Hypercholesterolemia
Frequency: 1 affected / 29 at risk

Adverse event: METABOLIC/LABORATORY:: Hyperglycemia
Serious: no
Organ System: Investigations
Notes: Hyperglycemia
Frequency: 13 affected / 29 at risk

Adverse event: METABOLIC/LABORATORY:: Hyperkalemia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 29 at risk

Adverse event: METABOLIC/LABORATORY:: Hypermagnesemia
Serious: no
Organ System: Investigations
Notes: Hypermagnesemia
Frequency: 7 affected / 29 at risk

Adverse event: METABOLIC/LABORATORY:: Hypernatremia
Serious: no
Organ System: Investigations
Notes: Hypernatremia
Frequency: 1 affected / 29 at risk

Adverse event: METABOLIC/LABORATORY:: Hyperuricemia
Serious: no
Organ System: Investigations
Notes: Hyperuricemia
Frequency: 6 affected / 29 at risk

Adverse event: METABOLIC/LABORATORY:: Hypocalcemia
Serious: no
Organ System: Investigations
Notes: Hypocalcemia
Frequency: 5 affected / 29 at risk

Adverse event: METABOLIC/LABORATORY:: Hypoglycemia
Serious: no
Organ System: Investigations
Notes: Hypoglycemia
Frequency: 4 affected / 29 at risk

Adverse event: METABOLIC/LABORATORY:: Hypokalemia
Serious: no
Organ System: Investigations
Notes: Hypokalemia
Frequency: 9 affected / 29 at risk

Adverse event: METABOLIC/LABORATORY:: Hypomagnesemia
Serious: no
Organ System: Investigations
Notes: Hypomagnesemia
Frequency: 9 affected / 29 at risk

Adverse event: METABOLIC/LABORATORY:: Hyponatremia
Serious: no
Organ System: Investigations
Notes: Hyponatremia
Frequency: 10 affected / 29 at risk

Adverse event: METABOLIC/LABORATORY:: Hypophosphatemia
Serious: no
Organ System: Investigations
Notes: Hypophosphatemia
Frequency: 6 affected / 29 at risk

Adverse event: METABOLIC/LABORATORY:: Lipase
Serious: no
Organ System: Investigations
Frequency: 1 affected / 29 at risk

Adverse event: METABOLIC/LABORATORY:: Metabolic/Laboratory-Other (Lactate)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 29 at risk

Adverse event: NEUROLOGY:: Dizziness/lightheadedness
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 29 at risk

Adverse event: NEUROLOGY:: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 29 at risk

Adverse event: NEUROLOGY:: Mood alteration-anxiety, agitation
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 29 at risk

Adverse event: NEUROLOGY:: Mood alteration-depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 29 at risk

Adverse event: NEUROLOGY:: Neuropathy - cranial
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 29 at risk

Adverse event: NEUROLOGY:: Neuropathy - motor
Serious: no
Organ System: Nervous system disorders
Notes: Tremor
Frequency: 3 affected / 29 at risk

Adverse event: OCULAR/VISUAL:: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 29 at risk

Adverse event: OCULAR/VISUAL:: Ocular/Visual-Other (Ocular other: uveitis)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 29 at risk

Adverse event: OCULAR/VISUAL:: Tearing (watery eyes)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 29 at risk

Adverse event: OCULAR/VISUAL:: Vision-blurred vision
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 29 at risk

Adverse event: OCULAR/VISUAL:: Vision-double vision (diplopia)
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 29 at risk

Adverse event: OCULAR/VISUAL:: Vision-photophobia
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 29 at risk

Adverse event: PAIN:: Abdominal pain or cramping
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 29 at risk

Adverse event: PAIN:: Arthralgia (joint pain)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 29 at risk

Adverse event: PAIN:: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: During infusion, probable bone marrow involvement with disease
Frequency: 2 affected / 29 at risk

Adverse event: PAIN:: Chest pain (non-cardiac and non-pleuritic)
Serious: no
Organ System: General disorders
Frequency: 4 affected / 29 at risk

Adverse event: PAIN:: Earache (otalgia)
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 29 at risk

Adverse event: PAIN:: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 29 at risk

Adverse event: PAIN:: Myalgia (muscle pain)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Back pain Generalized achiness/pain Low back pain Low back, hip pain Right thoracic pain muscular Tendonitis right shoulder Back abdominal pain
Frequency: 7 affected / 29 at risk

Adverse event: PAIN:: Pain-Other (Dental-anterior pillars tender;Foot, sharp and intermittent;Right eye ache)
Serious: no
Organ System: Nervous system disorders
Notes: Peripherally inserted central catheter site pain Pain other: pain in eyes Pain: in right finger Pain: in right shoulder
Frequency: 6 affected / 29 at risk

Adverse event: PAIN:: Pelvic pain
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Left inguinal pain
Frequency: 1 affected / 29 at risk

Adverse event: PAIN:: Tumor pain (onset or exacerbation of tumor pain due to treatment)
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Pain: right inguinal, (new lymph node)
Frequency: 1 affected / 29 at risk

Adverse event: PULMONARY:: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 29 at risk

Adverse event: PULMONARY:: Dyspnea (shortness of breath)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 29 at risk

Adverse event: PULMONARY:: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Infusional reaction Infusional reaction, occurred overnight
Frequency: 2 affected / 29 at risk

Adverse event: PULMONARY:: Pneumonitis/pulmonary infiltrates
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 29 at risk

Adverse event: PULMONARY:: Pneumothorax
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 29 at risk

Adverse event: RENAL/GENITOURINARY:: Creatinine
Serious: no
Organ System: Renal and urinary disorders
Notes: Creatinine
Frequency: 3 affected / 29 at risk

Adverse event: RENAL/GENITOURINARY:: Hemoglobinuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 29 at risk

Adverse event: RENAL/GENITOURINARY:: Proteinuria
Serious: no
Organ System: Renal and urinary disorders
Notes: Proteinuria
Frequency: 3 affected / 29 at risk

Adverse event: RENAL/GENITOURINARY:: Renal/Genitourinary-Other (Urine positive for white blood cells)
Serious: no
Organ System: Renal and urinary disorders
Notes: UTI
Frequency: 2 affected / 29 at risk

Adverse event: DERMATOLOGY/SKIN::Dermatology/Skin-Other(Thumb swelling)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 29 at risk