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Review Campath Safety Reports submitted to FDA

Total Campath reports: 300.
Campath FDA safety alerts: No.
Reported deaths: 118    Reported hospitalizations: 173.
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FDA Reported Campath Side Effects: renal failure acute, pancytopenia, diarrhoea, autoimmune disorder, death, pyrexia, bacteraemia, confusional state, febrile neutropenia, hypoxia, malignant neoplasm progression.
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Campath Side Effects Report #5745276-3
Physician from MALAYSIA reported CAMPATH problem on May 15, 2008. Male patient, 52 years of age, weighting 156.5 lb, was diagnosed with anaplastic large cell lymphoma t- and null-cell types and was treated with CAMPATH. After drug was administered, patient experienced the following problems/side effects: neutropenic sepsis. CAMPATH dosage: unknown. During the same period patient was treated with CYCLOPHOSPHAMIDE, VINCRISTINE. Patient died on 04/16/2008.

Campath Side Effects Report #5746189-3
CAMPATH problem was reported by a Consumer or non-health professional from UNITED KINGDOM on May 07, 2008. Female patient was diagnosed with b-cell lymphoma, prophylaxis against graft versus host disease and was treated with CAMPATH. After drug was administered, patient experienced the following problems/side effects: adenovirus infection, aspergillosis, bacterial sepsis, bk virus infection, cytomegalovirus infection, cytomegalovirus syndrome, herpes zoster, multi-organ failure, parainfluenzae virus infection. CAMPATH dosage: AS USED: 10 MG. During the same period patient was treated with CARMUSTINE, CYTARABINE, ETOPOSIDE, MELPHALAN, CYCLOSPORINE. Patient died.

Campath Side Effects Report #5747417-0
Health Professional from UNITED STATES reported CAMPATH problem on May 19, 2008. Female patient, 60 years of age, was diagnosed with bone marrow conditioning regimen and was treated with CAMPATH. After drug was administered, patient experienced the following problems/side effects: abdominal pain, acute pulmonary oedema, dyspnoea, hypervolaemia, hypotension. CAMPATH dosage: unknown. During the same period patient was treated with CLOFARABINE, MELPHALAN. Patient was hospitalized. Patient died on 05/16/2008.

Campath Side Effects Report #5747418-2
CAMPATH problem was reported by a Health Professional from UNITED STATES on May 20, 2008. Male patient, 75 years of age, weighting 235.9 lb, was diagnosed with chronic lymphocytic leukaemia and was treated with CAMPATH. After drug was administered, patient experienced the following problems/side effects: abdominal distension, abdominal pain, cytomegalovirus infection, diarrhoea, dyspnoea, graft versus host disease, hypotension, liver function test abnormal, multi-organ failure. CAMPATH dosage: unknown. During the same period patient was treated with FLUDARABINE PHOSPHATE, RITUXIMAB. Patient was hospitalized. Patient died on 11/17/2007.

Campath Side Effects Report #5749033-3
Consumer or non-health professional from UNITED STATES reported CAMPATH problem on May 20, 2008. Male patient, 63 years of age, weighting 269.0 lb, was diagnosed with chronic lymphocytic leukaemia, infection prophylaxis and was treated with CAMPATH. After drug was administered, patient experienced the following problems/side effects: brain herniation, convulsion, hypertension, meningitis viral, somnolence. CAMPATH dosage: unknown. During the same period patient was treated with FLUDARA, RITUXAN, BENADRYL, ACETAMINOPHEN, COTRIM, ACYCLOVIR, TRICOR, CYCLOBENZAPRINE. Patient was hospitalized. Patient died on 06/16/2006.

Campath Side Effects Report #5750348-3
CAMPATH problem was reported by a Health Professional from UNITED STATES on May 19, 2008. Female patient, 60 years of age, was diagnosed with bone marrow conditioning regimen and was treated with CAMPATH. After drug was administered, patient experienced the following problems/side effects: abdominal pain, acute pulmonary oedema, dyspnoea, hypervolaemia, hypotension. CAMPATH dosage: unknown. During the same period patient was treated with CLOFARABINE, MELPHALAN. Patient was hospitalized. Patient died on 05/16/2008.

Campath Side Effects Report #5751860-3
Physician from SWEDEN reported CAMPATH problem on May 14, 2008. Female patient, 61 years of age, was diagnosed with chronic lymphocytic leukaemia and was treated with CAMPATH. After drug was administered, patient experienced the following problems/side effects: hypotension, pyrexia. CAMPATH dosage: unknown. During the same period patient was treated with FLUDARA, BACTRIM, ACYCLOVIR, ACETAMINOPHEN, TAVEGYL, PETIDIN. Patient was hospitalized. Patient recovered.

Campath Side Effects Report #5751879-2
CAMPATH problem was reported by a Consumer or non-health professional from UNITED STATES on May 19, 2008. Male patient was diagnosed with malignant histiocytosis and was treated with CAMPATH. After drug was administered, patient experienced the following problems/side effects: chills, convulsion, hypertension. CAMPATH dosage: UNIT DOSE: 30 MG/ML. During the same period patient was treated with METHOTREXATE, CYCLOSPORINE, DEXAMETHASONE, BACTRIM, FLUCONAZOLE. Patient was hospitalized. Patient recovered.

Campath Side Effects Report #5751883-4
Health Professional from UNITED STATES reported CAMPATH problem on May 20, 2008. Male patient, 66 years of age, weighting 198.4 lb, was diagnosed with chronic lymphocytic leukaemia, infection prophylaxis and was treated with CAMPATH. After drug was administered, patient experienced the following problems/side effects: abdominal distension, acute respiratory distress syndrome, alanine aminotransferase increased, ascites, aspartate aminotransferase increased, atrial fibrillation, atrial flutter, blood bilirubin increased, blood creatinine increased. CAMPATH dosage: unknown. During the same period patient was treated with FLUDARA, RITUXIMAB, DIPHENHYDRAMINE, ACETAMINOPHEN, COTRIM, ASPIRIN, PLAVIX, COLACE. Patient was hospitalized. Patient died on 04/19/2007.

Campath Side Effects Report #5751912-8
CAMPATH problem was reported by a Physician from UNITED STATES on May 20, 2008. Female patient, 53 years of age, was diagnosed with chronic lymphocytic leukaemia and was treated with CAMPATH. After drug was administered, patient experienced the following problems/side effects: acute respiratory distress syndrome, anaemia haemolytic autoimmune, arthritis bacterial, clostridium difficile colitis, cytomegalovirus test positive, deep vein thrombosis, dizziness, glomerulonephropathy, granulocytes abnormal. CAMPATH dosage: unknown. During the same period patient was treated with FLUDARA, RITUXAN. Patient was hospitalized. Patient died on 07/05/2007.

Campath Side Effects Report #5694370-4
Physician from UNITED STATES reported CAMPATH problem on Mar 26, 2008. Female patient, 60 years of age, was diagnosed with chronic lymphocytic leukaemia, infection prophylaxis and was treated with CAMPATH. After drug was administered, patient experienced the following problems/side effects: bone marrow failure. CAMPATH dosage: TOTAL DAILY DOSE: 30 MG. During the same period patient was treated with BENADRYL, TYLENOL, BACTRIM, GANCICLOVIR. Patient recovered.

Campath Side Effects Report #5694788-X
CAMPATH problem was reported by a Physician from UNITED STATES on Mar 20, 2008. Female patient, 40 years of age, was diagnosed with multiple sclerosis and was treated with CAMPATH. After drug was administered, patient experienced the following problems/side effects: asthma, chest pain, depression, dyspepsia, dyspnoea, gastritis, headache, hemiparesis, hypoaesthesia. CAMPATH dosage: TOTAL DAILY DOSE: 24 MG. During the same period patient was treated with CYMBALTA, PRAVASTATIN, CLONAZEPAM, GABAPENTIN, TEMAZEPAM, HYDROCODONE BITARTRATE, VERAPAMIL, PROTONIX. Patient was hospitalized. Patient recovered.

Campath Side Effects Report #5697335-1
Consumer or non-health professional from UNITED KINGDOM reported CAMPATH problem on Mar 26, 2008. Male patient, 40 years of age, was diagnosed with chronic myeloid leukaemia and was treated with CAMPATH. After drug was administered, patient experienced the following problems/side effects: chronic graft versus host disease, hyperthyroidism, hypothyroidism. CAMPATH dosage: unknown. During the same period patient was treated with CYCLOPHOSPHAMIDE. Patient recovered.

Campath Side Effects Report #5697348-X
CAMPATH problem was reported by a Consumer or non-health professional from UNITED KINGDOM on Mar 26, 2008. Female patient, 20 years of age, was diagnosed with chronic myeloid leukaemia and was treated with CAMPATH. After drug was administered, patient experienced the following problems/side effects: anaemia haemolytic autoimmune, chronic graft versus host disease, hyperthyroidism. CAMPATH dosage: unknown. During the same period patient was treated with CYCLOPHOSPHAMIDE, CYCLOSPORINE. Patient recovered.

Campath Side Effects Report #5697349-1
Consumer or non-health professional from UNITED KINGDOM reported CAMPATH problem on Mar 26, 2008. Female patient, 17 years of age, was diagnosed with chronic myeloid leukaemia and was treated with CAMPATH. After drug was administered, patient experienced the following problems/side effects: chronic graft versus host disease, hyperthyroidism, hypothyroidism, inflammation, thyroiditis. CAMPATH dosage: unknown. During the same period patient was treated with CYCLOPHOSPHAMIDE. Patient recovered.

Campath Side Effects Report #5697352-1
CAMPATH problem was reported by a Physician from UNITED STATES on Mar 20, 2008. Female patient, 40 years of age, was diagnosed with multiple sclerosis and was treated with CAMPATH. After drug was administered, patient experienced the following problems/side effects: asthma, chest pain, depression, dyspepsia, dyspnoea, gastritis, headache, hemiparesis, hypoaesthesia. CAMPATH dosage: TOTAL DAILY DOSE: 24 MG. During the same period patient was treated with CYMBALTA, PRAVASTATIN, CLONAZEPAM, GABAPENTIN, TEMAZEPAM, HYDROCODONE BITARTRATE, VERAPAMIL, PROTONIX. Patient was hospitalized. Patient recovered.

Campath Side Effects Report #5697926-8
Physician from UNITED STATES reported CAMPATH problem on Apr 04, 2008. Female patient, 55 years of age, weighting 154.3 lb, was diagnosed with adult t-cell lymphoma/leukaemia and was treated with CAMPATH. After drug was administered, patient experienced the following problems/side effects: adult t-cell lymphoma/leukaemia, atrial fibrillation, blood amylase increased, blood triglycerides increased, bone marrow failure, febrile neutropenia, malignant neoplasm progression, nonspecific reaction, pancytopenia. CAMPATH dosage: 30MG THREE TIMES A WEEK IV DRIP. Patient recovered.

Campath Side Effects Report #5702839-9
CAMPATH problem was reported by a Consumer or non-health professional from UNITED STATES on Apr 10, 2008. Male patient, weighting 145.7 lb, was treated with CAMPATH. After drug was administered, patient experienced the following problems/side effects: platelet count decreased. CAMPATH dosage: 43 MG. During the same period patient was treated with CYCLOPHOSPHAMIDE, PENTOSTATIN, RITUXIMAB. Patient recovered.

Campath Side Effects Report #5703904-2
Physician from SWEDEN reported CAMPATH problem on Apr 03, 2008. Male patient, 66 years of age, was diagnosed with chronic lymphocytic leukaemia, pruritus, osteoporosis, prophylaxis and was treated with CAMPATH. After drug was administered, patient experienced the following problems/side effects: anaemia haemolytic autoimmune, autoimmune neutropenia, leukopenia. CAMPATH dosage: UNIT DOSE: 3 MG. During the same period patient was treated with FLUDARA, CLEMASTINE FUMARATE, CALCIUM CARBONATE, RISEDRONIC ACID, TRIMETHOPRIM. Patient was hospitalized. Patient recovered.

Campath Side Effects Report #5707896-1
CAMPATH problem was reported by a Consumer or non-health professional from UNITED STATES on Mar 17, 2008. Male patient, 55 years of age, weighting 295.4 lb, was diagnosed with chronic lymphocytic leukaemia and was treated with CAMPATH. After drug was administered, patient experienced the following problems/side effects: injection site erythema, injection site pruritus, injection site swelling. CAMPATH dosage: unknown. During the same period patient was treated with BENADRYL, TYLENOL, FAMVIR, BACTRIM DS, METFORMIN, PROTONIX, ALLOPURINOL, NASACORT. Patient recovered.

Campath Side Effects Report #5707949-8
Health Professional from UNITED STATES reported CAMPATH problem on Apr 04, 2008. Female patient, 56 years of age, weighting 271.2 lb, was diagnosed with liver transplant, prophylaxis against transplant rejection and was treated with CAMPATH. After drug was administered, patient experienced the following problems/side effects: liver function test abnormal. CAMPATH dosage: TOTAL DAILY DOSE: 30 MG. During the same period patient was treated with TACROLIMUS, MUPIROCIN, HYDROCORTISONE, CACO, LASIX, NORVASC. Patient recovered.

Campath Side Effects Report #5711067-2
CAMPATH problem was reported by a Physician from UNITED STATES on Apr 10, 2008. Female patient, 41 years of age, weighting 136.7 lb, was diagnosed with liver transplant and was treated with CAMPATH. After drug was administered, patient experienced the following problems/side effects: liver transplant rejection. CAMPATH dosage: UNIT DOSE: 30 MG. During the same period patient was treated with TACROLIMUS, PROTONIX, SEPTRA, VALCYTE, NORVASC. Patient was hospitalized. Patient recovered.

Campath Side Effects Report #5711080-5
Health Professional from UNITED STATES reported CAMPATH problem on Apr 14, 2008. Female patient, 42 years of age, weighting 174.2 lb, was diagnosed with relapsing-remitting multiple sclerosis and was treated with CAMPATH. After drug was administered, patient experienced the following problems/side effects: hypothyroidic goitre, ovarian epithelial cancer, papillary thyroid cancer, thyroidectomy. CAMPATH dosage: UNIT DOSE: 24 MG. During the same period patient was treated with SYNTHROID, PROVIGIL, MIDRIN, INDERAL LA, LORAZEPAM, PRILOSEC. Patient was hospitalized. Patient recovered.

Campath Side Effects Report #5715730-9
CAMPATH problem was reported by a Physician from FRANCE on Apr 14, 2008. Male patient, 79 years of age, weighting 143.3 lb, was diagnosed with chronic lymphocytic leukaemia and was treated with CAMPATH. After drug was administered, patient experienced the following problems/side effects: skin cancer. CAMPATH dosage: unknown. Patient recovered.

Campath Side Effects Report #5718098-7
Health Professional from UNITED STATES reported CAMPATH problem on Apr 17, 2008. Female patient, 53 years of age, weighting 271.2 lb, was diagnosed with liver transplant, prophylaxis against transplant rejection and was treated with CAMPATH. After drug was administered, patient experienced the following problems/side effects: liver function test abnormal, pyrexia. CAMPATH dosage: TOTAL DAILY DOSE: 30 MG. During the same period patient was treated with TACROLIMUS, MUPIROCIN, HYDROCORTISONE, CACO, LASIX, NORVASC. Patient was hospitalized. Patient recovered.

Campath Side Effects Report #5346413-5
CAMPATH problem was reported by a Physician from GERMANY on May 21, 2007. Male patient, weighting 187.4 lb, was treated with CAMPATH. After drug was administered, patient experienced the following problems/side effects: infection. CAMPATH dosage: 30 MG, UNK. Patient was hospitalized. Patient died on 07/25/2003.

Campath Side Effects Report #5346414-7
Physician from GERMANY reported CAMPATH problem on May 21, 2007. Male patient, weighting 176.4 lb, was treated with CAMPATH. After drug was administered, patient experienced the following problems/side effects: renal failure, tumour lysis syndrome. CAMPATH dosage: 30 MG/D, UNK. During the same period patient was treated with ACETAMINOPHEN, TAVEGIL. Patient was hospitalized. Patient died on 10/29/2004.

Campath Side Effects Report #5346415-9
CAMPATH problem was reported by a Physician from GERMANY on May 21, 2007. Male patient, 74 years of age, weighting 169.8 lb, was diagnosed with chronic lymphocytic leukaemia, prophylaxis and was treated with CAMPATH. After drug was administered, patient experienced the following problems/side effects: supraventricular tachycardia. CAMPATH dosage: 10 MG, UNK. During the same period patient was treated with COTRIM DS, PEGFILGRASTIM, FAMVIR, MERONEM, DIFLUCAN, PANTOZOL. Patient was hospitalized. Patient died on 01/19/2006.

Campath Side Effects Report #5349974-5
Pharmacist from UNITED KINGDOM reported CAMPATH problem on June 01, 2007. Male patient was treated with CAMPATH. CAMPATH dosage: 30 MG 3XWEEKLY. Patient died.

Campath Side Effects Report #5352614-2
CAMPATH problem was reported by a Physician from JAPAN on May 29, 2007. Male patient, 58 years of age, was treated with CAMPATH. After drug was administered, patient experienced the following problems/side effects: cerebral haemorrhage, dyspnoea, hypertension, pyrexia, tremor. CAMPATH dosage: 7.8 MG, AFTER 3 DAYS. During the same period patient was treated with DEXAMETHASONE, IFOSFAMIDE, ELSPAR, METHOTREXATE, LEUCOVORIN CALCIUM. Patient died.

Campath Side Effects Report #5352723-8
Consumer or non-health professional from ITALY reported CAMPATH problem on June 07, 2007. Female patient, 36 years of age, was diagnosed with transplant rejection and was treated with CAMPATH. After drug was administered, patient experienced the following problems/side effects: dermatitis bullous, necrosis, pain, rash. CAMPATH dosage: 18 MG, 1 DOSE. During the same period patient was treated with DARILIN, DISSENTEN, LANSOX, LASIX, NORVASK, PROGRAF, RAPAMUNE, ROCALTROL. Patient was hospitalized. Patient recovered.

Campath Side Effects Report #5356077-2
CAMPATH problem was reported by a Physician from GERMANY on June 07, 2007. Male patient, weighting 235.9 lb, was treated with CAMPATH. After drug was administered, patient experienced the following problems/side effects: disturbance in attention, tumour lysis syndrome. CAMPATH dosage: 3 MG, 1 DOSE. During the same period patient was treated with RAMIPRIL, METOPROLOL SUCCINATE, ACETAMINOPHEN, VALTREX, TAVEGIL. Patient died on 07/11/2004.

Campath Side Effects Report #5357650-8
Health Professional from UNITED STATES reported CAMPATH problem on June 01, 2007. Male patient, 67 years of age, weighting 153.0 lb, was diagnosed with chronic lymphocytic leukaemia, hypertension, diabetes mellitus and was treated with CAMPATH. After drug was administered, patient experienced the following problems/side effects: mental status changes, renal failure acute, renal tubular necrosis, sepsis syndrome, syncope. CAMPATH dosage: 30 MG/DAY, D1-5 EVERY 28 DAYS. During the same period patient was treated with FLUDARA, DIOVAN HCT, AVANDIA, FAMVIR, BACTRIM DS, NOVOLOG. Patient was hospitalized. Patient recovered.

Campath Side Effects Report #5360827-9
CAMPATH problem was reported by a Physician from GERMANY on June 18, 2007. Male patient, weighting 176.4 lb, was treated with CAMPATH. After drug was administered, patient experienced the following problems/side effects: renal failure, tumour lysis syndrome. CAMPATH dosage: 30 MG/D, UNK. During the same period patient was treated with ACETAMINOPHEN, TAVEGIL. Patient was hospitalized. Patient died on 10/29/2004.

Campath Side Effects Report #5360831-0
Physician from GERMANY reported CAMPATH problem on June 18, 2007. Male patient, weighting 154.3 lb, was treated with CAMPATH. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, blood lactate dehydrogenase increased, c-reactive protein increased, diarrhoea. CAMPATH dosage: 30 MG, UNK. Patient died on 03/06/2006.

Campath Side Effects Report #5360832-2
CAMPATH problem was reported by a Physician from GERMANY on June 07, 2007. Male patient, 74 years of age, weighting 169.8 lb, was diagnosed with chronic lymphocytic leukaemia, prophylaxis and was treated with CAMPATH. After drug was administered, patient experienced the following problems/side effects: supraventricular tachycardia. CAMPATH dosage: 10 MG, UNK. During the same period patient was treated with COTRIM DS, PEGFILGRASTIM, FAMVIR, MERONEM, DIFLUCAN, PANTOZOL. Patient was hospitalized. Patient recovered.

Campath Side Effects Report #5360834-6
Physician from GERMANY reported CAMPATH problem on June 18, 2007. Male patient, weighting 235.9 lb, was treated with CAMPATH. After drug was administered, patient experienced the following problems/side effects: disturbance in attention, tumour lysis syndrome. CAMPATH dosage: 3 MG, 1 DOSE. During the same period patient was treated with RAMIPRIL, BELOC ZOK, ACETAMINOPHEN, VALTREX, TAVEGIL. Patient died on 07/11/2004.

Campath Side Effects Report #5360843-7
CAMPATH problem was reported by a Pharmacist from UNITED STATES on June 04, 2007. Male patient, 70 years of age, was treated with CAMPATH. After drug was administered, patient experienced the following problems/side effects: hospitalisation. CAMPATH dosage: 3 MG, 1 DOSE. Patient was hospitalized. Patient recovered.

Campath Side Effects Report #5360856-5
Pharmacist from UNITED KINGDOM reported CAMPATH problem on June 12, 2007. Male patient was treated with CAMPATH. After drug was administered, patient experienced the following problems/side effects: malignant neoplasm progression. CAMPATH dosage: 30 MG X3D PRIOR TO ICE TX. During the same period patient was treated with IFOSFAMIDE, CARBOPLATIN, ETOPOSIDE. Patient died.

Campath Side Effects Report #5362493-5
CAMPATH problem was reported by a Health Professional from UNITED STATES on June 04, 2007. Male patient, 65 years of age, was diagnosed with osteoporosis, prophylaxis and was treated with CAMPATH. After drug was administered, patient experienced the following problems/side effects: anaemia haemolytic autoimmune, autoimmune neutropenia, leukopenia. CAMPATH dosage: 3 MG, 1 DOSE. During the same period patient was treated with FLUDARA, CLEMASTINE FUMARATE, CALCIUM CARBONATE, RISEDRONIC ACID, SULFAMETHOXAZOLE W. Patient was hospitalized. Patient recovered.

Campath Side Effects Report #5365803-8
Physician from UNITED STATES reported CAMPATH problem on June 19, 2007. Female patient, 45 years of age, was diagnosed with bone marrow conditioning regimen and was treated with CAMPATH. After drug was administered, patient experienced the following problems/side effects: anaemia haemolytic autoimmune, autoimmune neutropenia, neutropenic sepsis. CAMPATH dosage: 60 MG, UNK. During the same period patient was treated with FILGRASTIM, ANTIINFECTIVES, CYCLOPHOSPHAMIDE. Patient recovered.

Campath Side Effects Report #5367778-4
CAMPATH problem was reported by a Physician from UNITED STATES on June 11, 2007. Female patient was diagnosed with infection prophylaxis and was treated with CAMPATH. After drug was administered, patient experienced the following problems/side effects: brain herniation, encephalitic infection, meningitis viral. CAMPATH dosage: 3/10/30 MG TIWX6 WEEKS. During the same period patient was treated with FLUDARA, RITUXAN, BENADRYL, ACETAMINOPHEN, COTRIM. Patient died on 06/01/2006.

Campath Side Effects Report #5369734-9
Physician from UNITED STATES reported CAMPATH problem on June 19, 2007. Female patient was diagnosed with stem cell transplant and was treated with CAMPATH. After drug was administered, patient experienced the following problems/side effects: autoimmune disorder, pancytopenia. CAMPATH dosage: unknown. During the same period patient was treated with CYCLOPHOSPHAMIDE. Patient recovered.

Campath Side Effects Report #5369735-0
CAMPATH problem was reported by a Physician from UNITED STATES on June 19, 2007. Female patient was diagnosed with stem cell transplant and was treated with CAMPATH. After drug was administered, patient experienced the following problems/side effects: autoimmune disorder, pancytopenia. CAMPATH dosage: unknown. During the same period patient was treated with CYCLOPHOSPHAMIDE. Patient recovered.

Campath Side Effects Report #5369738-6
Physician from UNITED STATES reported CAMPATH problem on June 19, 2007. Female patient was diagnosed with stem cell transplant and was treated with CAMPATH. After drug was administered, patient experienced the following problems/side effects: autoimmune disorder, pancytopenia. CAMPATH dosage: unknown. During the same period patient was treated with CYCLOPHOSPHAMIDE. Patient recovered.

Campath Side Effects Report #5372279-3
CAMPATH problem was reported by a Physician from UNITED STATES on June 19, 2007. Female patient was diagnosed with stem cell transplant and was treated with CAMPATH. After drug was administered, patient experienced the following problems/side effects: autoimmune disorder, pancytopenia. CAMPATH dosage: unknown. During the same period patient was treated with CYCLOPHOSPHAMIDE. Patient recovered.

Campath Side Effects Report #5372280-X
Physician from UNITED STATES reported CAMPATH problem on June 19, 2007. Female patient was diagnosed with stem cell transplant and was treated with CAMPATH. After drug was administered, patient experienced the following problems/side effects: autoimmune disorder, pancytopenia. CAMPATH dosage: unknown. During the same period patient was treated with CYCLOPHOSPHAMIDE. Patient recovered.

Campath Side Effects Report #5372288-4
CAMPATH problem was reported by a Physician from UNITED STATES on June 19, 2007. Female patient was diagnosed with stem cell transplant and was treated with CAMPATH. After drug was administered, patient experienced the following problems/side effects: autoimmune disorder, pancytopenia. CAMPATH dosage: unknown. During the same period patient was treated with CYCLOPHOSPHAMIDE. Patient recovered.

Campath Side Effects Report #5373455-6
Physician from GERMANY reported CAMPATH problem on June 18, 2007. Male patient, weighting 154.3 lb, was treated with CAMPATH. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, blood lactate dehydrogenase increased, c-reactive protein increased, diarrhoea. CAMPATH dosage: 30 MG, UNK. Patient died on 03/06/2006.

Campath Side Effects Report #5373457-X
CAMPATH problem was reported by a Physician from GERMANY on June 18, 2007. Male patient, weighting 176.4 lb, was treated with CAMPATH. After drug was administered, patient experienced the following problems/side effects: renal failure, tumour lysis syndrome. CAMPATH dosage: 30 MG/D, UNK. During the same period patient was treated with ACETAMINOPHEN, TAVEGIL. Patient was hospitalized. Patient died on 10/29/2004.

Campath Side Effects Report #5373468-4
Physician from GERMANY reported CAMPATH problem on June 18, 2007. Male patient, weighting 235.9 lb, was treated with CAMPATH. After drug was administered, patient experienced the following problems/side effects: disturbance in attention, tumour lysis syndrome. CAMPATH dosage: 3 MG, 1 DOSE. During the same period patient was treated with RAMIPRIL, BELOC ZOK, ACETAMINOPHEN, VALTREX, TAVEGIL. Patient died on 07/11/2004.

Campath Side Effects Report #5374401-1
CAMPATH problem was reported by a Physician from UNITED STATES on June 22, 2007. Female patient, 64 years of age, weighting 142.0 lb, was diagnosed with wolff-parkinson-white syndrome, infection prophylaxis and was treated with CAMPATH. After drug was administered, patient experienced the following problems/side effects: diarrhoea, injection site infection, malignant neoplasm progression, mycobacterium chelonei infection. CAMPATH dosage: unknown. During the same period patient was treated with PREVACID, TENORMIN, ACYCLOVIR, BACTRIM, PYRIDIUM. Patient died on 01/01/2007.

Campath Side Effects Report #5314874-3
Health Professional from UNITED KINGDOM reported CAMPATH problem on Apr 23, 2007. Male patient, 61 years of age, weighting 173.7 lb, was diagnosed with prophylaxis against transplant rejection and was treated with CAMPATH. After drug was administered, patient experienced the following problems/side effects: lymphoproliferative disorder. CAMPATH dosage: 30 MG, UNK. During the same period patient was treated with METHYLPREDNISOLONE, TACROLIMUS, MYCOPHENOLATE MOFETIL, SIROLIMUS, NYSTATIN, ASPIRIN, OMEPRAZOLE. Patient was hospitalized. Patient recovered.

Campath Side Effects Report #5314875-5
CAMPATH problem was reported by a Health Professional from UNITED KINGDOM on Apr 19, 2007. Male patient, 64 years of age, weighting 188.5 lb, was diagnosed with renal transplant, prophylaxis against transplant rejection, hypertension, sleep disorder and was treated with CAMPATH. After drug was administered, patient experienced the following problems/side effects: lymphoproliferative disorder. CAMPATH dosage: 30 MG DAY 0 AND DAY +1(2DOSES). During the same period patient was treated with TACROLIMUS, MYCOPHENOLATE MOFETIL, AZATHIOPRINE, NIFEDIPINE, OMEPRAZOLE, ASPIRIN, ARANESP, CLONAZEPAM. Patient recovered.

Campath Side Effects Report #5316177-X
Health Professional from UNITED KINGDOM reported CAMPATH problem on Apr 23, 2007. Male patient, 68 years of age, was diagnosed with infection prophylaxis and was treated with CAMPATH. After drug was administered, patient experienced the following problems/side effects: lymphoproliferative disorder, sepsis. CAMPATH dosage: 30 MG, DAY 0 + DAY +1(2DOSES). During the same period patient was treated with METHYLPREDNISOLONE, TACROLIMUS, RAPAMYCIN, MYCOPHENOLATE MOFETIL, SEPTRIN, OMEPRAZOLE. Patient died on 08/11/2005.

Campath Side Effects Report #5320743-5
CAMPATH problem was reported by a Health Professional from AUSTRIA on Apr 28, 2007. Male patient, 67 years of age, was diagnosed with infection prophylaxis and was treated with CAMPATH. After drug was administered, patient experienced the following problems/side effects: basal cell carcinoma, malignant melanoma, malignant melanoma in situ, metastases to lymph nodes, metastases to soft tissue. CAMPATH dosage: 3 MG, 1 DOSE. During the same period patient was treated with VALACYCLOVIR, SULFAMETHOXAZOLE W. Patient recovered.

Campath Side Effects Report #5320745-9
Consumer or non-health professional from AUSTRIA reported CAMPATH problem on Apr 28, 2007. Male patient, 87 years of age, was treated with CAMPATH. After drug was administered, patient experienced the following problems/side effects: myelodysplastic syndrome. CAMPATH dosage: unknown. Patient died on 03/21/2006.

Campath Side Effects Report #5320746-0
CAMPATH problem was reported by a Consumer or non-health professional from AUSTRIA on Apr 28, 2007. Male patient, 72 years of age, was treated with CAMPATH. After drug was administered, patient experienced the following problems/side effects: malignant neoplasm progression, multiple myeloma, paraproteinaemia. CAMPATH dosage: unknown. Patient died on 09/30/2006.

Campath Side Effects Report #5321701-7
Health Professional from UNITED STATES reported CAMPATH problem on May 04, 2007. Male patient, 58 years of age, weighting 268.1 lb, was treated with CAMPATH. After drug was administered, patient experienced the following problems/side effects: bacteraemia, catheter related infection, catheter site haemorrhage, cerebral atrophy, cholelithiasis, coagulopathy, dialysis, disseminated intravascular coagulation, enterococcal infection. CAMPATH dosage: 30 MG, D1-5 EVERY 28 DAYS. During the same period patient was treated with FLUDARA. Patient was hospitalized. Patient died on 11/28/2006.

Campath Side Effects Report #5321705-4
CAMPATH problem was reported by a Physician from UNITED STATES on Apr 25, 2007. Female patient, 62 years of age, was treated with CAMPATH. After drug was administered, patient experienced the following problems/side effects: neuropathy. CAMPATH dosage: unknown. During the same period patient was treated with FLUDARABINE PHOSPHATE. Patient was hospitalized. Patient recovered.

Campath Side Effects Report #5324262-1
Health Professional from UNITED STATES reported CAMPATH problem on Apr 30, 2007. Female patient, 65 years of age, was diagnosed with osteoporosis, prophylaxis and was treated with CAMPATH. After drug was administered, patient experienced the following problems/side effects: anaemia haemolytic autoimmune, autoimmune neutropenia, leukopenia. CAMPATH dosage: 3 MG, 1 DOSE. During the same period patient was treated with FLUDARA, CLEMASTINE FUMARATE, CALCIUM CARBONATE, RISEDRONIC ACID, SULFAMETHOXAZOLE W. Patient was hospitalized. Patient recovered.

Campath Side Effects Report #5324278-5
CAMPATH problem was reported by a Health Professional from AUSTRIA on May 02, 2007. Female patient, 79 years of age, was diagnosed with chronic lymphocytic leukaemia, infection prophylaxis and was treated with CAMPATH. After drug was administered, patient experienced the following problems/side effects: keratoacanthoma, pulmonary embolism. CAMPATH dosage: 3 MG, 1 DOSE. During the same period patient was treated with VALACYCLOVIR, SULFAMETHOXAZOLE W. Patient died on 04/11/2005.

Campath Side Effects Report #5324279-7
Physician from UNITED STATES reported CAMPATH problem on May 03, 2007. Female patient was diagnosed with infection prophylaxis and was treated with CAMPATH. CAMPATH dosage: unknown. During the same period patient was treated with FLUCONAZOLE, VALACYCLOVIR. Patient died.

Campath Side Effects Report #5325076-9
CAMPATH problem was reported by a Pharmacist from UNITED STATES on May 11, 2007. Male patient, 68 years of age, was treated with CAMPATH. After drug was administered, patient experienced the following problems/side effects: anaemia. CAMPATH dosage: 30MG INJECTION 4 DOSES IN 14D. During the same period patient was treated with DOXORUBICIN, ACETAMINOPHEN, SINEMET, BENADRYL, LASIX, LISINOPRIL, MRITAZAPINE. Patient was hospitalized. Patient recovered.

Campath Side Effects Report #5326699-3
Physician from UNITED STATES reported CAMPATH problem on May 04, 2007. Female patient, 62 years of age, was treated with CAMPATH. After drug was administered, patient experienced the following problems/side effects: neuropathy. CAMPATH dosage: unknown. During the same period patient was treated with FLUDARABINE PHOSPHATE. Patient was hospitalized. Patient recovered.

Campath Side Effects Report #5328008-2
CAMPATH problem was reported by a Physician from UNITED STATES on May 03, 2007. Female patient was diagnosed with stem cell transplant and was treated with CAMPATH. After drug was administered, patient experienced the following problems/side effects: autoimmune disorder, pancytopenia. CAMPATH dosage: unknown. During the same period patient was treated with CYCLOPHOSPHAMIDE. Patient recovered.

Campath Side Effects Report #5328009-4
Physician from UNITED STATES reported CAMPATH problem on May 03, 2007. Female patient was diagnosed with stem cell transplant and was treated with CAMPATH. After drug was administered, patient experienced the following problems/side effects: autoimmune disorder, pancytopenia. CAMPATH dosage: unknown. During the same period patient was treated with CYCLOPHOSPHAMIDE. Patient recovered.

Campath Side Effects Report #5328010-0
CAMPATH problem was reported by a Physician from UNITED STATES on May 03, 2007. Female patient was diagnosed with stem cell transplant and was treated with CAMPATH. After drug was administered, patient experienced the following problems/side effects: autoimmune disorder, pancytopenia. CAMPATH dosage: unknown. During the same period patient was treated with CYCLOPHOSPHAMIDE. Patient recovered.

Campath Side Effects Report #5328364-5
Health Professional from UNITED STATES reported CAMPATH problem on May 15, 2007. Male patient was treated with CAMPATH. After drug was administered, patient experienced the following problems/side effects: blood creatinine increased, blood potassium increased, blood urea increased, gallbladder disorder, haematocrit decreased, haemoglobin decreased, nausea, platelet count decreased, pyrexia. CAMPATH dosage: unknown. During the same period patient was treated with BUSULFAN. Patient died on 05/11/2007.

Campath Side Effects Report #5329037-5
CAMPATH problem was reported by a Consumer or non-health professional from ITALY on May 11, 2007. Female patient, 55 years of age, weighting 110.2 lb, was diagnosed with haematological malignancy and was treated with CAMPATH. After drug was administered, patient experienced the following problems/side effects: blood lactate dehydrogenase increased, hypercalcaemia, hypertension, pyrexia, renal failure acute. CAMPATH dosage: CUMULATIVE DOSE GIVEN: 223MG. During the same period patient was treated with ACYCLOVIR, AMOXICILLIN W, BACTRIM, CIPROFLOXACIN, EUTIROX, PARIET, FLUDARA. Patient was hospitalized. Patient recovered.

Campath Side Effects Report #5331563-X
Physician from SPAIN reported CAMPATH problem on May 18, 2007. Male patient, 55 years of age, was diagnosed with infection and was treated with CAMPATH. After drug was administered, patient experienced the following problems/side effects: multi-organ failure. CAMPATH dosage: unknown. During the same period patient was treated with FOSCARNET, MEROPENEM, FUROSEMIDE, METHYLPREDNISOLONE, CASPOFUNGIN, MYCOPHENOLATE. Patient died on 05/09/2007.

Campath Side Effects Report #5332578-8
CAMPATH problem was reported by a Consumer or non-health professional from ITALY on May 11, 2007. Female patient, 55 years of age, weighting 110.2 lb, was diagnosed with haematological malignancy and was treated with CAMPATH. After drug was administered, patient experienced the following problems/side effects: hypercalcaemia, renal failure acute. CAMPATH dosage: CUMULATIVE DOSE GIVEN: 223MG. During the same period patient was treated with ACYCLOVIR, AMOXICILLIN W, BACTRIM, CIPROFLOXACIN, EUTIROX, PARIET, FLUDARA. Patient was hospitalized. Patient recovered.

Campath Side Effects Report #5340757-9
Health Professional from UNITED KINGDOM reported CAMPATH problem on May 30, 2007. Male patient was treated with CAMPATH. After drug was administered, patient experienced the following problems/side effects: alveolitis allergic, lower respiratory tract infection. CAMPATH dosage: unknown. During the same period patient was treated with FLUDARABINE PHOSPHATE, CYCLOPHOSPHAMIDE. Patient was hospitalized. Patient recovered.

Campath Side Effects Report #5287903-3
CAMPATH problem was reported by a Health Professional from UNITED STATES on Mar 29, 2007. Male patient, 58 years of age, weighting 268.1 lb, was treated with CAMPATH. After drug was administered, patient experienced the following problems/side effects: bacteraemia, coagulopathy, haemorrhage, hepatic failure, hypotension, hypoxia, intestinal ischaemia, multi-organ failure, pancytopenia. CAMPATH dosage: 30 MG, D1-5 EVERY 28 DAYS. During the same period patient was treated with FLUDARA. Patient was hospitalized. Patient died on 11/28/2006.

Campath Side Effects Report #5291205-9
Physician from UNITED STATES reported CAMPATH problem on Mar 28, 2007. Female patient, 52 years of age, was diagnosed with infection prophylaxis and was treated with CAMPATH. After drug was administered, patient experienced the following problems/side effects: hepatitis toxic. CAMPATH dosage: 30 MG/D, 1X/DAY. During the same period patient was treated with FLUDARABINE PHOSPHATE, ACYCLOVIR, ARGININE. Patient was hospitalized. Patient recovered.

Campath Side Effects Report #5293694-2
CAMPATH problem was reported by a Physician from UNITED STATES on Apr 04, 2007. Female patient, 40 years of age, was diagnosed with infection prophylaxis and was treated with CAMPATH. After drug was administered, patient experienced the following problems/side effects: psychotic disorder. CAMPATH dosage: 3 MG, 1 DOSE. During the same period patient was treated with BENADRYL, DECADRON, FAMVIR. Patient was hospitalized. Patient recovered.

Campath Side Effects Report #5294376-3
Consumer or non-health professional from UNITED STATES reported CAMPATH problem on Apr 09, 2007. Male patient was diagnosed with mycosis fungoides and was treated with CAMPATH. After drug was administered, patient experienced the following problems/side effects: abdominal pain, acute respiratory failure, aspiration, blood bicarbonate decreased, diarrhoea, hypovolaemia, mental status changes, no therapeutic response, pneumonia cytomegaloviral. CAMPATH dosage: 30MG. During the same period patient was treated with LIDA MANTEL CREAM, PRAMOSONE, COMBIVENT, ALLOPURINOL, CALCIUM ACETATE, EUCERIN, EMOLLIENTS, NEXIUM. Patient was hospitalized. Patient recovered.

Campath Side Effects Report #5294377-5
CAMPATH problem was reported by a Consumer or non-health professional from UNITED STATES on Apr 09, 2007. Male patient, 61 years of age, was diagnosed with mycosis fungoides and was treated with CAMPATH. After drug was administered, patient experienced the following problems/side effects: acute prerenal failure, anuria, diarrhoea, haemodialysis, hyperkalaemia, hyperphosphataemia, hypovolaemia, metabolic acidosis, oedema. CAMPATH dosage: 30MG. During the same period patient was treated with ALLOPURINOL, CALCIUM ACETATE, RENAGAL, FLUCONAZOLE, VANCOMYCIN, ACETAMINOPHEN, DIPHENHYDRAMINE, VALGANCICLOVIR. Patient was hospitalized. Patient recovered.

Campath Side Effects Report #5294378-7
Consumer or non-health professional from UNITED STATES reported CAMPATH problem on Apr 09, 2007. Male patient was diagnosed with mycosis fungoides and was treated with CAMPATH. After drug was administered, patient experienced the following problems/side effects: cytomegalovirus viraemia, enterococcal infection, renal failure, respiratory failure, tumour lysis syndrome. CAMPATH dosage: 30MG. Patient was hospitalized. Patient recovered.

Campath Side Effects Report #5294463-X
CAMPATH problem was reported by a Consumer or non-health professional from UNITED STATES on Apr 09, 2007. Male patient, weighting 242.5 lb, was treated with CAMPATH. After drug was administered, patient experienced the following problems/side effects: agitation, confusional state, delirium, diarrhoea, hypotension, hypoxia, mental status changes, nausea, oral intake reduced. CAMPATH dosage: 90 MG. Patient was hospitalized. Patient recovered.

Campath Side Effects Report #5306245-0
Health Professional from UNITED KINGDOM reported CAMPATH problem on Apr 19, 2007. Female patient, 61 years of age, was diagnosed with prophylaxis against transplant rejection and was treated with CAMPATH. After drug was administered, patient experienced the following problems/side effects: lymphoproliferative disorder. CAMPATH dosage: 30 MG DAY 0 AND DAY +1. During the same period patient was treated with METHYLPREDNISOLONE, TACROLIMUS, MYCOPHENOLATE MOFETIL, SIROLIMUS. Patient recovered.

Campath Side Effects Report #5306247-4
CAMPATH problem was reported by a Health Professional from UNITED KINGDOM on Apr 19, 2007. Female patient, 68 years of age, was treated with CAMPATH. After drug was administered, patient experienced the following problems/side effects: lymphoproliferative disorder. CAMPATH dosage: 30 MG, DAY 0 AND DAY +1. During the same period patient was treated with METHYLPREDNISOLONE, TACROLIMUS, RAPAMYCIN, MYCOPHENOLATE MOFETIL. Patient died.

Campath Side Effects Report #5307429-8
Physician from UNITED STATES reported CAMPATH problem on Apr 10, 2007. Female patient, 62 years of age, was treated with CAMPATH. After drug was administered, patient experienced the following problems/side effects: neuropathy. CAMPATH dosage: unknown. During the same period patient was treated with FLUDARABINE PHOSPHATE. Patient was hospitalized. Patient recovered.

Campath Side Effects Report #5310265-X
CAMPATH problem was reported by a Physician from UNITED STATES on Apr 20, 2007. Female patient, 58 years of age, was diagnosed with bone marrow conditioning regimen, prophylaxis against graft versus host disease and was treated with CAMPATH. After drug was administered, patient experienced the following problems/side effects: encephalitis herpes. CAMPATH dosage: unknown. During the same period patient was treated with TACROLIMUS, METHYLPREDNISOLONE, FLUDARABINE, MELPHALAN. Patient died.

Campath Side Effects Report #5315644-2
Consumer or non-health professional from UNITED STATES reported CAMPATH problem on Apr 30, 2007. Male patient, weighting 220.0 lb, was treated with CAMPATH. After drug was administered, patient experienced the following problems/side effects: febrile neutropenia, pancytopenia. CAMPATH dosage: 1483 MG. During the same period patient was treated with BACTRIM DS, DIFLUCAN, PRILOSEC, ACYCLOVIR, NEULASTA. Patient was hospitalized. Patient recovered.

Campath Side Effects Report #5253457-0
CAMPATH problem was reported by a Health Professional from UNITED STATES on Feb 15, 2007. Female patient, 65 years of age, was diagnosed with osteoporosis, prophylaxis and was treated with CAMPATH. After drug was administered, patient experienced the following problems/side effects: anaemia haemolytic autoimmune, autoimmune neutropenia, leukopenia. CAMPATH dosage: 3 MG, 1 DOSE. During the same period patient was treated with FLUDARA, CLEMASTINE FUMARATE, CALCIUM CARBONATE, RISEDRONIC ACID, SULFAMETHOXAZOLE W. Patient was hospitalized. Patient recovered.

Campath Side Effects Report #5255527-X
Health Professional from FRANCE reported CAMPATH problem on Feb 26, 2007. Male patient, 70 years of age, weighting 176.4 lb, was treated with CAMPATH. After drug was administered, patient experienced the following problems/side effects: chills, injection site inflammation, injection site mass, muscle spasms, tremor. CAMPATH dosage: unknown. Patient was hospitalized. Patient recovered.

Campath Side Effects Report #5262941-5
CAMPATH problem was reported by a Health Professional from UNITED STATES on Feb 27, 2007. Female patient, 65 years of age, was diagnosed with osteoporosis, prophylaxis and was treated with CAMPATH. After drug was administered, patient experienced the following problems/side effects: anaemia haemolytic autoimmune, autoimmune neutropenia, leukopenia. CAMPATH dosage: 3 MG, 1 DOSE. During the same period patient was treated with FLUDARA, CLEMASTINE FUMARATE, CALCIUM CARBONATE, RISEDRONIC ACID, SULFAMETHOXAZOLE W. Patient was hospitalized. Patient recovered.

Campath Side Effects Report #5269176-0
Physician from UNITED STATES reported CAMPATH problem on Mar 13, 2007. Male patient, 58 years of age, weighting 196.0 lb, was treated with CAMPATH. After drug was administered, patient experienced the following problems/side effects: adenovirus infection, bronchopneumonia, chronic lymphocytic leukaemia transformation, hypoxic encephalopathy, renal failure. CAMPATH dosage: unknown. During the same period patient was treated with FLUDARA, ADRIAMYCIN PFS, RITUXAN, ADRIAMYCIN PFS, VINCRISTINE, NEULASTA. Patient was hospitalized. Patient died on 11/27/2006.

Campath Side Effects Report #5269188-7
CAMPATH problem was reported by a Physician from UNITED KINGDOM on Mar 05, 2007. Male patient, 68 years of age, weighting 154.3 lb, was diagnosed with chronic lymphocytic leukaemia recurrent, prophylaxis and was treated with CAMPATH. After drug was administered, patient experienced the following problems/side effects: erythema multiforme, thrombocytopenia. CAMPATH dosage: 30 MG, UNK. During the same period patient was treated with VALCYTE. Patient recovered.

Campath Side Effects Report #5270205-9
Physician from UNITED STATES reported CAMPATH problem on Mar 08, 2007. Female patient, 62 years of age, was diagnosed with prophylaxis and was treated with CAMPATH. After drug was administered, patient experienced the following problems/side effects: hepatitis cholestatic. CAMPATH dosage: 30 MG, 3X/WEEK. During the same period patient was treated with FLUDARABINE PHOSPHATE, ACYCLOVIR. Patient was hospitalized. Patient recovered.

Campath Side Effects Report #5271464-9
CAMPATH problem was reported by a Health Professional from BELGIUM on Mar 15, 2007. Male patient, 26 years of age, was diagnosed with t-cell lymphoma and was treated with CAMPATH. After drug was administered, patient experienced the following problems/side effects: acute respiratory distress syndrome, multi-organ failure, tumour lysis syndrome. CAMPATH dosage: 3 MG, 1 DOSE. During the same period patient was treated with CYCLOPHOSPHAMIDE W, DOXORUBICIN, ALLOPURI