TRASTUZUMAB Side Effects

7020448-9 | Cardiovascular Disorder
on Jun 15, 2010 Female patient from GERMANY , weighting 176.4 lb, was diagnosed with breast cancer (What is breast cancer?) and was treated with Trastuzumab (View Usage). Patient experienced the following unwanted or unexpected effects: cardiovascular disorder. Trastuzumab dosage: Form: Infusion, Frequency Not Reported, Last Dose Prior To Sae: 10 Jun 2010, Cycle 1.. During the same period patient was treated with EPIRUBICIN (Form: Infusion, Frequency Not Reported, Last Dose Prior To Sae: 10 Jun 2010, Cycle 1) (View Epirubicin Review and Epirubicin Label ), CYCLOPHOSPHAMIDE (Form: Infusion, Frequency Not Reported, Last Dose Prior To Sae: 10 Jun 2010, Cycle 1) (View Cyclophosphamide Review and Cyclophosphamide Label ), IVEMEND (View Ivemend Review and Ivemend Label ), FORTECORTIN (View Fortecortin Review and Fortecortin Label ), KEVATRIL (View Kevatril Review and Kevatril Label ). Patient was hospitalized.

7018128-9 | Hypokalaemia, Neutropenia
Patient was taking Trastuzumab (View Usage). Patient had the following side effects: hypokalaemia, neutropenia on Sep 20, 2010 from UNITED KINGDOM Additional patient health information: Female patient , 57 years of age, was diagnosed with breast cancer (What is breast cancer?) and. Trastuzumab dosage: On Day 1, Week 1 Only. During the same period patient was treated with CARBOPLATIN (View Carboplatin Review and Carboplatin Label ), DOCETAXEL (View Docetaxel Review and Docetaxel Label ), LAPATINIB (View Lapatinib Review and Lapatinib Label ), PEGFILGRASTIM (View Pegfilgrastim Review and Pegfilgrastim Label ).

7016715-5 | Abscess, Wound Complication
Adverse event was reported on Sep 14, 2010 by a Female patient taking Trastuzumab (View Usage) (Dosage: Form Reported As Vials. ^total Dose Reported As 443 Mg^. Temporarily Stopped.) . Location: UNITED STATES , weighting 159.2 lb, After Trastuzumab was administered, patient had the following side effects: abscess (What is abscess?), wound complication. During the same period patient was treated with DOCETAXEL (Form Reported As Vials. ^total Dose Reported As 134 Mg^. Last Dose Prior To Sae On 08 June 2009) (View Docetaxel Review and Docetaxel Label ), CARBOPLATIN (Form Reported As Vials. Dosing Amount Reported As 6 Auc.) (View Carboplatin Review and Carboplatin Label ), CEFAZOLIN (View Cefazolin Review and Cefazolin Label ), LOVENOX (View Lovenox Review and Lovenox Label ), TORADOL (View Toradol Review and Toradol Label ), ATIVAN (View Ativan Review and Ativan Label ), TYLENOL (View Tylenol Review and Tylenol Label ). Patient was hospitalized.

7014623-7 | Hypokalaemia, Nausea, Neutrophil Count, White Blood Cell Count
on Sep 21, 2010 Female patient from UNITED STATES , weighting 176.4 lb, was diagnosed with breast cancer (What is breast cancer?) and was treated with Trastuzumab (View Usage). Patient experienced the following unwanted or unexpected effects: hypokalaemia, nausea (What is nausea?), neutrophil count, white blood cell count. Trastuzumab dosage: Loading Dose: 8 Mg/kg, Total Dose: 656 Mg, Form: Vials, Last Dose Prior To Sae: 14 July 2010.. During the same period patient was treated with DOCETAXEL (Form: Vials, Total Dose: 136 Mg, Last Dose Prior To Sae: 14 July 2010.) (View Docetaxel Review and Docetaxel Label ), CARBOPLATIN (Dose Level: 6, Units: Auc, Form: Vials, Last Dose Prior To Sae: 14 July 2010.) (View Carboplatin Review and Carboplatin Label ), LOVASTATIN (View Lovastatin Review and Lovastatin Label ), ASPIRIN (View Aspirin Review and Aspirin Label ), AMLODIPINE (View Amlodipine Review and Amlodipine Label ). Patient was hospitalized.


7012686-6 | Myocardial Ischaemia
on Sep 16, 2010 Female patient from AUSTRALIA , weighting 149.9 lb, was treated with Trastuzumab (View Usage). Patient had the following side effects: myocardial ischaemia. Trastuzumab dosage: Loading Dose. Form: Vial. During the same period patient was treated with CARBOPLATIN (Form: Vial, Last Dose Prior To Sae: 22 April 2010. Dose Level: 6 Auc) (View Carboplatin Review and Carboplatin Label ), DOCETAXEL (Form: Vial, Dose Level: 75 Mg/m2, Date Of Last Dose Prior To Sae: 22 April 2010.) (View Docetaxel Review and Docetaxel Label ), PANADOL (Frequency: Prn) (View Panadol Review and Panadol Label ), IBUPROFEN TABLETS (View Ibuprofen Tablets Review and Ibuprofen Tablets Label ), NOLVADEX (View Nolvadex Review and Nolvadex Label ). Patient was hospitalized.

7012616-7 | Pancytopenia, Thrombocytopenia
Patient was taking Trastuzumab (View Usage). After Trastuzumab was administered, patient had the following side effects: pancytopenia, thrombocytopenia on Sep 20, 2010 from AUSTRIA Additional patient health information: Female patient , weighting 114.6 lb, was diagnosed with breast cancer (What is breast cancer?) and. Trastuzumab dosage: Loading Dose.. During the same period patient was treated with DOCETAXEL (Form: Vial, Last Dose Prior To Sae: 02 October 2009 (dose Level : 60g/m2), Permanently Discontinued.) (View Docetaxel Review and Docetaxel Label ), CARBOPLATIN (Form: Vial, Last Dose Prior To Sae: 02 October 2009, Dose Level: 5 Auc, Permanently Discontinued.) (View Carboplatin Review and Carboplatin Label ), PANTOLOC (View Pantoloc Review and Pantoloc Label ), FEMARA (View Femara Review and Femara Label ). Patient was hospitalized.

7012612-X | Cow's Milk Intolerance, Milia, Nasal Congestion, Respiratory Syncytial Virus Infection, Respiratory Tract Infection, Rhinorrhoea, Ventricular Septal Defect
Adverse event was reported on Sep 13, 2010 by a Male patient taking Trastuzumab (View Usage) (Dosage: ) was diagnosed with breast cancer (What is breast cancer?), rash (What is rash?), nasal congestion, respiratory syncytial virus infection (What is respiratory syncytial virus infection?) and. Location: UNITED STATES , weighting 16.31 lb, Patient experienced the following unwanted or unexpected effects: cow's milk intolerance, milia, nasal congestion, respiratory syncytial virus infection (What is respiratory syncytial virus infection?), respiratory tract infection, rhinorrhoea, ventricular septal defect. During the same period patient was treated with NYSTATIN (Unk) (View Nystatin Review and Nystatin Label ), BACTROBAN (Unk) (View Bactroban Review and Bactroban Label ), ZITHROMAX (Unk) (View Zithromax Review and Zithromax Label ), CHLORPHENIRAMINE/DEXTROMETHORPHAN/GUAIACOL/METHOXYPHENAMINE (Unk) (View Chlorpheniramine/dextromethorphan/guaiacol/methoxyphenamine Review and Chlorpheniramine/dextromethorphan/guaiacol/methoxyphenamine Label ), ALBUTEROL (Unk) (View Albuterol Review and Albuterol Label ).

7007806-3 | Gastritis
on Sep 09, 2010 Female patient from GERMANY , weighting 112.4 lb, was diagnosed with breast cancer (What is breast cancer?) and was treated with Trastuzumab (View Usage). Patient had the following side effects: gastritis. Trastuzumab dosage: Dose Form: Vials, Last Dose Prior To Sae 25 August 2010, Dose Level: 6 Mg/kg. During the same period patient was treated with BEVACIZUMAB (Dose Level: 15 Mg/kg, Form: Vials, Last Dose Prior To Sae: 25 Aug 2010) (View Bevacizumab Review and Bevacizumab Label ), DOCETAXEL (Form: Vials, Dose Level: 75 Mg/m2, Last Dose Prior To Sae 25 Aug 2010,) (View Docetaxel Review and Docetaxel Label ), CARBOPLATIN (Form: Vials, Dose Level: 06 Mg/ml/min (auc), Last Dose Prior To Sae: 25 Aug 2010) (View Carboplatin Review and Carboplatin Label ), CITALOPRAM HYDROBROMIDE (View Citalopram Hydrobromide Review and Citalopram Hydrobromide Label ). Patient was hospitalized.

7007784-7 | Diarrhoea, Syncope
on Sep 15, 2010 Female patient from POLAND , weighting 145.5 lb, was treated with Trastuzumab (View Usage). After Trastuzumab was administered, patient had the following side effects: diarrhoea, syncope. Trastuzumab dosage: Form: Vial, Loading Dose. During the same period patient was treated with BEVACIZUMAB (Form: Vials, Dose: 15 Mg/kg. Last Dose Prior To Sae: 26 Jul 2010) (View Bevacizumab Review and Bevacizumab Label ), DOCETAXEL (Form: Vial, Dose: 75 Mg/m2) (View Docetaxel Review and Docetaxel Label ), CARBOPLATIN (Form: Vial, Dose: 6 Auc) (View Carboplatin Review and Carboplatin Label ), AXTIL (View Axtil Review and Axtil Label ), ZYRTEC (View Zyrtec Review and Zyrtec Label ). Patient was hospitalized.

6992522-4 | Dehydration, Neutropenic Infection, Skin Infection
Patient was taking Trastuzumab (View Usage). Patient experienced the following unwanted or unexpected effects: dehydration, neutropenic infection, skin infection on Sep 09, 2010 from UNITED STATES Additional patient health information: Female patient , weighting 174.2 lb, . Trastuzumab dosage: Dose Level: 6 Mg/kg, Dosage Form : Vials Last Dose Prior To Sae: 16 October 2009.. During the same period patient was treated with BEVACIZUMAB (Dose Level: 15mg/kg, Dosage Form : Vials. Permanently Discontinued.) (View Bevacizumab Review and Bevacizumab Label ), CARBOPLATIN (Dose Level : 6 Auc, Dosage Form : Vials) (View Carboplatin Review and Carboplatin Label ), DOCETAXEL (Dose Level : 75 Mg/m2; Form: Vial) (View Docetaxel Review and Docetaxel Label ), MOBIC (View Mobic Review and Mobic Label ), ALOXI (View Aloxi Review and Aloxi Label ), DECADRON (View Decadron Review and Decadron Label ). Patient was hospitalized.

6980274-3 | Constipation, Decreased Appetite, Dehydration, Diarrhoea, Hypokalaemia, Nausea, Neutropenia, Neutrophil Count, Urinary Tract Infection
Adverse event was reported on Sep 09, 2010 by a Female patient taking Trastuzumab (View Usage) (Dosage: Loading Dose: 8 Mg/kg, Total Dose: 656 Mg, Form: Vials, Last Dose Prior To Sae: 14 July 2010.) was diagnosed with breast cancer (What is breast cancer?) and. Location: UNITED STATES , weighting 176.4 lb, Patient had the following side effects: constipation (What is constipation?), decreased appetite, dehydration, diarrhoea, hypokalaemia, nausea (What is nausea?), neutropenia, neutrophil count, urinary tract infection (What is urinary tract infection?). During the same period patient was treated with DOCETAXEL (Form: Vials, Total Dose: 136 Mg, Last Dose Prior To Sae: 14 July 2010.) (View Docetaxel Review and Docetaxel Label ), CARBOPLATIN (Dose Level: 6, Units: Auc, Form: Vials, Last Dose Prior To Sae: 14 July 2010.) (View Carboplatin Review and Carboplatin Label ), LOVASTATIN (View Lovastatin Review and Lovastatin Label ), ASPIRIN (View Aspirin Review and Aspirin Label ), AMLODIPINE (View Amlodipine Review and Amlodipine Label ). Patient was hospitalized.

6976987-X | Abscess, Appendicitis Perforated, Febrile Neutropenia
on Sep 02, 2010 Female patient from UNITED STATES , weighting 346.1 lb, was diagnosed with pain (What is pain?), diarrhoea and was treated with Trastuzumab (View Usage). After Trastuzumab was administered, patient had the following side effects: abscess (What is abscess?), appendicitis perforated, febrile neutropenia. Trastuzumab dosage: Form: Bolus Last Dose Prior To Sae: 16 June 2010. During the same period patient was treated with BEVACIZUMAB (Route: Iv Bolus, Last Dose Prior Sae: 16 August 2010) (View Bevacizumab Review and Bevacizumab Label ), VINORELBINE (Route: Iv Push, Last Dose Prior Sae: 16 August 2010) (View Vinorelbine Review and Vinorelbine Label ), IBUPROFEN (Frequency: Q6h Prn) (View Ibuprofen Review and Ibuprofen Label ), METOPROLOL TARTRATE (Frequency: Q12h) (View Metoprolol Tartrate Review and Metoprolol Tartrate Label ), VALIUM (Frequency: Qid Prn) (View Valium Review and Valium Label ), XELODA (Other Indication: Fatigue) (View Xeloda Review and Xeloda Label ). Patient was hospitalized.

6976955-8 | Chest Pain, Febrile Neutropenia
on Sep 03, 2010 Female patient from UNITED STATES , weighting 188.5 lb, was diagnosed with breast cancer (What is breast cancer?), pain (What is pain?) and was treated with Trastuzumab (View Usage). Patient experienced the following unwanted or unexpected effects: chest pain (What is chest pain?), febrile neutropenia. Trastuzumab dosage: Loading Dose, Form: Vials. During the same period patient was treated with BEVACIZUMAB (Form: Vials, Total Dose: 1275 Mg, Date Of Last Dose Prior To Sae: 07 July 2010) (View Bevacizumab Review and Bevacizumab Label ), CARBOPLATIN (Form: Vials, Dose Level: 6 Auc, Date Of Last Dose Prior To Sae: 07 July 2010) (View Carboplatin Review and Carboplatin Label ), DOCETAXEL (Form: Vials, Total Dose:140 Mg, Date Of Last Dose Prior To Sae: 07 July 2010) (View Docetaxel Review and Docetaxel Label ), OXYCODONE (View Oxycodone Review and Oxycodone Label ), DECADRON (View Decadron Review and Decadron Label ). Patient was hospitalized.

6968319-8 | Chest Pain
Patient was taking Trastuzumab (View Usage). Patient had the following side effects: chest pain (What is chest pain?) on Aug 27, 2010 from UNITED STATES Additional patient health information: Female patient , weighting 274.9 lb, was diagnosed with breast cancer (What is breast cancer?) and. Trastuzumab dosage: Loading Dose.. During the same period patient was treated with IXABEPILONE (View Ixabepilone Review and Ixabepilone Label ), CARBOPLATIN (View Carboplatin Review and Carboplatin Label ), COUMADIN (Daily) (View Coumadin Review and Coumadin Label ), LASIX (Daily, As Necesary) (View Lasix Review and Lasix Label ), NEURONTIN (Frequency: Qid) (View Neurontin Review and Neurontin Label ), OMEPRAZOLE (Daily) (View Omeprazole Review and Omeprazole Label ), OXYCODONE HCL AND ACETAMINOPHEN (Dose: 10/325, Frequency: Q6hrpm) (View Oxycodone Hcl And Acetaminophen Review and Oxycodone Hcl And Acetaminophen Label ). Patient was hospitalized.

6965677-5 | Pancytopenia
Adverse event was reported on Sep 02, 2010 by a Female patient taking Trastuzumab (View Usage) (Dosage: Form: Vials, Total Dose: 402 Mg, Last Dose Prior To Sae: 3 August 2010.) . Location: GERMANY , weighting 147.7 lb, After Trastuzumab was administered, patient had the following side effects: pancytopenia. During the same period patient was treated with BEVACIZUMAB (Form: Vials, Total Dose Was Reported As 1005 Mg. Date Of Last Dose Prior To Sae: 03 August 2010) (View Bevacizumab Review and Bevacizumab Label ), CARBOPLATIN (Dose Reported As 6 Auc And Total Dose As 810 Mg. Form: Vials, Last Dose Prior To Sae:3 August 2010) (View Carboplatin Review and Carboplatin Label ), DOCETAXEL (Form: Vials, Total Dose: 1237 Mg.) (View Docetaxel Review and Docetaxel Label ), METODURA (View Metodura Review and Metodura Label ). Patient was hospitalized.

6965600-3 | Infection
on Aug 26, 2010 Female patient from GERMANY , weighting 127.9 lb, was diagnosed with breast cancer (What is breast cancer?) and was treated with Trastuzumab (View Usage). Patient experienced the following unwanted or unexpected effects: infection (What is infection?). Trastuzumab dosage: Form: Infusion Per Protocol. During the same period patient was treated with EPIRUBICIN (Dose: 90 Mg/ml) (View Epirubicin Review and Epirubicin Label ), CYCLOPHOSPHAMIDE (Form: Infusion Per Protocol) (View Cyclophosphamide Review and Cyclophosphamide Label ), RANITIC (View Ranitic Review and Ranitic Label ), FENISTIL (View Fenistil Review and Fenistil Label ), DEXAMETHASONE TAB (View Dexamethasone Tab Review and Dexamethasone Tab Label ), KEVATRIL (View Kevatril Review and Kevatril Label ). Patient was hospitalized.

6963770-4 | Abscess, Appendicitis Perforated, Febrile Neutropenia
on Aug 25, 2010 Female patient from UNITED STATES , weighting 346.1 lb, was diagnosed with pain (What is pain?) and was treated with Trastuzumab (View Usage). Patient had the following side effects: abscess (What is abscess?), appendicitis perforated, febrile neutropenia. Trastuzumab dosage: . During the same period patient was treated with BEVACIZUMAB (Route: Iv Bolus, Last Dose Prior Sae: 16 August 2010) (View Bevacizumab Review and Bevacizumab Label ), VINORELBINE (Route: Iv Push, Last Dose Prior Sae: 16 August 2010) (View Vinorelbine Review and Vinorelbine Label ), IBUPROFEN (Frequency: Q6ii Prn) (View Ibuprofen Review and Ibuprofen Label ), METOPROLOL TARTRATE (Frequency: Q12h) (View Metoprolol Tartrate Review and Metoprolol Tartrate Label ), VALIUM (Frequency: Qid Prn) (View Valium Review and Valium Label ). Patient was hospitalized.

6962962-8 | Hypokalaemia, Nausea, Neutrophil Count, White Blood Cell Count
Patient was taking Trastuzumab (View Usage). After Trastuzumab was administered, patient had the following side effects: hypokalaemia, nausea (What is nausea?), neutrophil count, white blood cell count on Aug 25, 2010 from UNITED STATES Additional patient health information: Female patient , weighting 176.4 lb, was diagnosed with breast cancer (What is breast cancer?) and. Trastuzumab dosage: Loading Dose: 8 Mg/kg, Total Dose: 656 Mg, Form: Vials, Last Dose Prior To Sae: 14 July 2010.. During the same period patient was treated with DOCETAXEL (Form: Vials, Total Dose: 136 Mg, Last Dose Prior To Sae: 14 July 2010.) (View Docetaxel Review and Docetaxel Label ), CARBOPLATIN (Dose Level: 6, Units: Auc, Form: Vials, Last Dose Prior To Sae: 14 July 2010.) (View Carboplatin Review and Carboplatin Label ), LOVASTATIN (View Lovastatin Review and Lovastatin Label ), ASPIRIN (View Aspirin Review and Aspirin Label ), AMLODIPINE (View Amlodipine Review and Amlodipine Label ). Patient was hospitalized.

6962957-4 | Interstitial Lung Disease
Adverse event was reported on Aug 27, 2010 by a Male patient taking Trastuzumab (View Usage) (Dosage: 8 Mg/kg, Single) was diagnosed with breast cancer (What is breast cancer?) and. Location: UNITED STATES , weighting 176.4 lb, Patient experienced the following unwanted or unexpected effects: interstitial lung disease. During the same period patient was treated with TRASTUZUMAB MCC DM1 (281.5 Mg, Unk) (View Trastuzumab-mcc-dm1 Review and Trastuzumab-mcc-dm1 Label ), ABRAXANE (260 Mg/m2, Single) (View Abraxane Review and Abraxane Label ). Patient was hospitalized and became disabled.

6960824-3 | Renal Failure Acute
on Aug 25, 2010 Female patient from UNITED STATES , weighting 246.9 lb, was diagnosed with breast cancer (What is breast cancer?) and was treated with Trastuzumab (View Usage). Patient had the following side effects: renal failure acute. Trastuzumab dosage: Form: Vial, Dose Level: 8. During the same period patient was treated with DOCETAXEL (Dose Level: 75) (View Docetaxel Review and Docetaxel Label ), CARBOPLATIN (Dose Level: 6, Last Dose Prior To Sae: 13 Aug 2010, Uinit: Auc, Form:vial) (View Carboplatin Review and Carboplatin Label ), BENICAR (View Benicar Review and Benicar Label ), IRON (View Iron Review and Iron Label ), COMPAZINE (Prn) (View Compazine Review and Compazine Label ), DEXMETHSONE (View Dexmethsone Review and Dexmethsone Label ), RANITIDINE (View Ranitidine Review and Ranitidine Label ), EMEND (Tri Pack) (View Emend Review and Emend Label ). Patient was hospitalized.

6960807-3 | Renal Failure Acute
on Aug 30, 2010 Female patient from UNITED STATES , weighting 246.9 lb, was diagnosed with breast cancer (What is breast cancer?) and was treated with Trastuzumab (View Usage). After Trastuzumab was administered, patient had the following side effects: renal failure acute. Trastuzumab dosage: Form: Vial, Dose Level: 8. During the same period patient was treated with DOCETAXEL (Dose Level: 75) (View Docetaxel Review and Docetaxel Label ), CARBOPLATIN (Dose Level: 6, Last Dose Prior To Sae: 13 Aug 2010, Uinit: Auc, Form:vial) (View Carboplatin Review and Carboplatin Label ), BENICAR (View Benicar Review and Benicar Label ), IRON (View Iron Review and Iron Label ), COMPAZINE (Prn) (View Compazine Review and Compazine Label ), DEXMETHSONE (View Dexmethsone Review and Dexmethsone Label ), RANITIDINE (View Ranitidine Review and Ranitidine Label ), EMEND (Tri Pack) (View Emend Review and Emend Label ). Patient was hospitalized.

6960776-6 | Pancytopenia
Patient was taking Trastuzumab (View Usage). Patient experienced the following unwanted or unexpected effects: pancytopenia on Aug 30, 2010 from GERMANY Additional patient health information: Female patient , weighting 147.7 lb, . Trastuzumab dosage: Form: Vials, Total Dose: 402 Mg, Last Dose Prior To Sae: 3 August 2010.. During the same period patient was treated with BEVACIZUMAB (Form: Vials, Total Dose Was Reported As 1005 Mg. Date Of Last Dose Prior To Sae: 03 August 2010) (View Bevacizumab Review and Bevacizumab Label ), CARBOPLATIN (Dose Reported As 6 Auc And Total Dose As 810 Mg. Form: Vials, Last Dose Prior To Sae:3 August 2010) (View Carboplatin Review and Carboplatin Label ), DOCETAXEL (Form: Vials, Total Dose: 1237 Mg.) (View Docetaxel Review and Docetaxel Label ), METODURA (View Metodura Review and Metodura Label ). Patient was hospitalized.

6958617-6 | Diarrhoea, Syncope
Adverse event was reported on Aug 18, 2010 by a Female patient taking Trastuzumab (View Usage) (Dosage: Form: Vial, Loading Dose) . Location: POLAND , weighting 145.5 lb, Patient had the following side effects: diarrhoea, syncope. During the same period patient was treated with BEVACIZUMAB (Form: Vials, Dose: 15 Mg/kg. Last Dose Prior To Sae: 26 Jul 2010) (View Bevacizumab Review and Bevacizumab Label ), DOCETAXEL (Form: Vial, Dose: 75 Mg/m2) (View Docetaxel Review and Docetaxel Label ), CARBOPLATIN (Form: Vial, Dose: 6 Auc) (View Carboplatin Review and Carboplatin Label ), AXTIL (View Axtil Review and Axtil Label ), ZYRTEC (View Zyrtec Review and Zyrtec Label ). Patient was hospitalized.

6958398-6 | Ileus
on Aug 24, 2010 Female patient from UNITED STATES , weighting 154.3 lb, was treated with Trastuzumab (View Usage). After Trastuzumab was administered, patient had the following side effects: ileus. Trastuzumab dosage: . During the same period patient was treated with CAPECITABINE (3600 Mg, Qd) (View Capecitabine Review and Capecitabine Label ), LAPATINIB (1250 Mg, Qd) (View Lapatinib Review and Lapatinib Label ), NAVELBINE (View Navelbine Review and Navelbine Label ). Patient was hospitalized.

6958351-2 | Angina Pectoris, Cardiac Failure, Cardiac Failure Congestive
on Aug 19, 2010 Female patient from UNITED KINGDOM , weighting 150.4 lb, was diagnosed with breast cancer (What is breast cancer?) and was treated with Trastuzumab (View Usage). Patient experienced the following unwanted or unexpected effects: angina pectoris, cardiac failure, cardiac failure congestive. Trastuzumab dosage: Loading Dose.. During the same period patient was treated with GABAPENTIN (View Gabapentin Review and Gabapentin Label ), MANEVAC (View Manevac Review and Manevac Label ), ACETAMINOPHEN (View Acetaminophen Review and Acetaminophen Label ), DIHYDROCODEINE TARTRATE (View Dihydrocodeine Tartrate Review and Dihydrocodeine Tartrate Label ), TEMAZEPAM (View Temazepam Review and Temazepam Label ), CLONIDINE HYDROCHLORIDE (View Clonidine Hydrochloride Review and Clonidine Hydrochloride Label ), METFORMIN HCL (View Metformin Hcl Review and Metformin Hcl Label ). Patient was hospitalized.

6955827-9 | Pancytopenia
Patient was taking Trastuzumab (View Usage). Patient had the following side effects: pancytopenia on Aug 19, 2010 from GERMANY Additional patient health information: Female patient , weighting 147.7 lb, . Trastuzumab dosage: Form: Vials, Total Dose: 402 Mg, Last Dose Prior To Sae: 3 August 2010.. During the same period patient was treated with BEVACIZUMAB (Form: Vials, Total Dose Was Reported As 1005 Mg. Date Of Last Dose Prior To Sae: 03 August 2010) (View Bevacizumab Review and Bevacizumab Label ), CARBOPLATIN (Dose Reported As 6 Auc And Total Dose As 810 Mg. Form: Vials, Last Dose Prior To Sae:3 August 2010) (View Carboplatin Review and Carboplatin Label ), DOCETAXEL (Form: Vials, Total Dose: 1237 Mg.) (View Docetaxel Review and Docetaxel Label ), METODURA (View Metodura Review and Metodura Label ). Patient was hospitalized.

6955816-4 | Dehydration
Adverse event was reported on Aug 25, 2010 by a Female patient taking Trastuzumab (View Usage) (Dosage: Loading Dose, Form: Vial) . Location: UNITED STATES , weighting 146.2 lb, After Trastuzumab was administered, patient had the following side effects: dehydration. During the same period patient was treated with BEVACIZUMAB (Dose Level: 15 Mg/kg, Form: Vials) (View Bevacizumab Review and Bevacizumab Label ), CARBOPLATIN (Dose Level: 6 Auc, Form: Vials) (View Carboplatin Review and Carboplatin Label ), DOCETAXEL (Dose Level: 75 Mg/m2, Form: Vial) (View Docetaxel Review and Docetaxel Label ). Patient was hospitalized.

6955815-2 | Dehydration
on Aug 18, 2010 Female patient from UNITED STATES , weighting 146.2 lb, was treated with Trastuzumab (View Usage). Patient experienced the following unwanted or unexpected effects: dehydration. Trastuzumab dosage: Loading Dose, Form: Vial. During the same period patient was treated with BEVACIZUMAB (Dose Level: 15 Mg/kg, Form: Vials) (View Bevacizumab Review and Bevacizumab Label ), CARBOPLATIN (Dose Level: 6 Auc, Form: Vials) (View Carboplatin Review and Carboplatin Label ), DOCETAXEL (Dose Level: 75 Mg/m2, Form: Vial) (View Docetaxel Review and Docetaxel Label ). Patient was hospitalized.

6955772-9 | Chest Pain, Febrile Neutropenia
on Aug 23, 2010 Female patient from UNITED STATES , weighting 134.9 lb, was treated with Trastuzumab (View Usage). Patient had the following side effects: chest pain (What is chest pain?), febrile neutropenia. Trastuzumab dosage: Last Dose : 30 July 2010. During the same period patient was treated with BEVACIZUMAB (View Bevacizumab Review and Bevacizumab Label ), TAXOTERE (Last Dose: 30 July 2010) (View Taxotere Review and Taxotere Label ). Patient was hospitalized.

6945467-X | Arthralgia, Bone Pain, Dizziness, Tooth Disorder, Toothache
Patient was taking Trastuzumab (View Usage). After Trastuzumab was administered, patient had the following side effects: arthralgia, bone pain, dizziness (What is dizziness?), tooth disorder (What is tooth disorder?), toothache on Aug 19, 2010 from MEXICO Additional patient health information: Female patient , weighting 187.4 lb, . Trastuzumab dosage: .

6945438-3 | Recall Phenomenon
Adverse event was reported on Aug 06, 2010 by a Female patient taking Trastuzumab (View Usage) (Dosage: ) . Location: FRANCE , 74 years of age, Patient experienced the following unwanted or unexpected effects: recall phenomenon. During the same period patient was treated with DOCETAXEL (View Docetaxel Review and Docetaxel Label ), CARBOPLATIN (View Carboplatin Review and Carboplatin Label ).

6945429-2 | Muscular Weakness, Urinary Tract Infection
on Aug 17, 2010 Female patient from JAPAN , weighting 103.6 lb, was treated with Trastuzumab (View Usage). Patient had the following side effects: muscular weakness, urinary tract infection (What is urinary tract infection?). Trastuzumab dosage: Loading Dose.. During the same period patient was treated with PERTUZUMAB (Dosage Form: Infusion) (View Pertuzumab Review and Pertuzumab Label ), DOCETAXEL (Dosage Form: Infusion, Dose As Per Protocol) (View Docetaxel Review and Docetaxel Label ), METOCLOPRAMIDE (View Metoclopramide Review and Metoclopramide Label ), TEPRENONE (View Teprenone Review and Teprenone Label ), LANSOPRAZOLE (View Lansoprazole Review and Lansoprazole Label ), FERROUS SULFATE TAB (View Ferrous Sulfate Tab Review and Ferrous Sulfate Tab Label ), FUROSEMIDE (View Furosemide Review and Furosemide Label ). Patient was hospitalized.

6945340-7 | Cellulitis, Diarrhoea, Herpes Zoster
on Aug 26, 2010 Female patient from KOREA, REPUBLIC OF , weighting 145.5 lb, was treated with Trastuzumab (View Usage). After Trastuzumab was administered, patient had the following side effects: cellulitis (What is cellulitis?), diarrhoea, herpes zoster. Trastuzumab dosage: Form Reported As Infusion. During the same period patient was treated with PERTUZUMAB (Form Reported As Infusion) (View Pertuzumab Review and Pertuzumab Label ), DOCETAXEL (Form: Infusion) (View Docetaxel Review and Docetaxel Label ), HEXAMIDINE (View Hexamidine Review and Hexamidine Label ). Patient was hospitalized.

6942899-0 | Recall Phenomenon
Patient was taking Trastuzumab (View Usage). Patient experienced the following unwanted or unexpected effects: recall phenomenon on Aug 06, 2010 from FRANCE Additional patient health information: Female patient , 74 years of age, . Trastuzumab dosage: . During the same period patient was treated with DOCETAXEL (View Docetaxel Review and Docetaxel Label ), CARBOPLATIN (View Carboplatin Review and Carboplatin Label ).

6942801-1 | Skin Nodule
Adverse event was reported on Aug 20, 2010 by a Female patient taking Trastuzumab (View Usage) (Dosage: Loading Dose) was diagnosed with breast cancer (What is breast cancer?) and. Location: BRAZIL , weighting 158.7 lb, Patient had the following side effects: skin nodule. During the same period patient was treated with PERTUZUMAB (Last Dose Prior To Sae: 29 October 2009.) (View Pertuzumab Review and Pertuzumab Label ), DOCETAXEL (Batch No: 03 Vials 20 Mg D8ca09, And 01 Vial 80 Mg D9a117, Last Dose Prior To Sae; 17 Feb 2010) (View Docetaxel Review and Docetaxel Label ), FLUOROURACIL (Date Of Last Dose Prior To Sae: 22 April 2010.) (View Fluorouracil Review and Fluorouracil Label ), EPIRUBICIN (Last Dose Prior To Sae: 22 April 2010.) (View Epirubicin Review and Epirubicin Label ), CYCLOPHOSPHAMIDE (Last Dose Prior To Sae: 22 April 2010.) (View Cyclophosphamide Review and Cyclophosphamide Label ), CAPTOPRIL (View Captopril Review and Captopril Label ), HYDROCHLOROTHIAZIDE (View Hydrochlorothiazide Review and Hydrochlorothiazide Label ).

6942761-3 | Diarrhoea, Neutropenia, Syncope
on Aug 19, 2010 Female patient from GERMANY , weighting 174.2 lb, was diagnosed with hypertonia, thrombosis prophylaxis and was treated with Trastuzumab (View Usage). After Trastuzumab was administered, patient had the following side effects: diarrhoea, neutropenia, syncope. Trastuzumab dosage: Total Dose: 504 Mg; Form: Vials, Last Dose Prior To Sae:13 July 2009, Loading Dose. During the same period patient was treated with DOCETAXEL (Total Dose: 147 Mg; Form: Vials Last Dose Prior To Sae: 13 July 2009.) (View Docetaxel Review and Docetaxel Label ), CARBOPLATIN (Dose Level: 6 Auc, Form: Vials,last Dose Prior To Sae: 13 July 2009.) (View Carboplatin Review and Carboplatin Label ), ATACAND HCT (View Atacand Hct Review and Atacand Hct Label ), SIMVASTATIN (View Simvastatin Review and Simvastatin Label ), PANTOPRAZOLE SODIUM (View Pantoprazole Sodium Review and Pantoprazole Sodium Label ), CLEXANE (View Clexane Review and Clexane Label ). Patient was hospitalized.

6940675-6 | Haemoptysis, Pneumonia Aspiration
on Aug 18, 2010 Female patient from KOREA, REPUBLIC OF , weighting 119.0 lb, was treated with Trastuzumab (View Usage). Patient experienced the following unwanted or unexpected effects: haemoptysis, pneumonia aspiration. Trastuzumab dosage: Loading Dose: 8 Mg/kg As Per Protocol.. During the same period patient was treated with PERTUZUMAB (Loading Dose) (View Pertuzumab Review and Pertuzumab Label ), DOCETAXEL (Last Dose Prior To Sae: 20 May 2010. Form Infusion.) (View Docetaxel Review and Docetaxel Label ), AVANDAMET (View Avandamet Review and Avandamet Label ), DICAMAX (View Dicamax Review and Dicamax Label ), FENOFIBRATE (View Fenofibrate Review and Fenofibrate Label ), BENZYDAMINE HCL (Dose: Gargle) (View Benzydamine Hcl Review and Benzydamine Hcl Label ). Patient was hospitalized.

6940664-1 | Abscess, Infection, Sepsis, Wound Complication
Patient was taking Trastuzumab (View Usage). Patient had the following side effects: abscess (What is abscess?), infection (What is infection?), sepsis (What is sepsis?), wound complication on Aug 17, 2010 from UNITED STATES Additional patient health information: Female patient , weighting 159.2 lb, . Trastuzumab dosage: Form Reported As Vials. ^total Dose Reported As 443 Mg^. Temporarily Stopped.. During the same period patient was treated with DOCETAXEL (Form Reported As Vials. ^total Dose Reported As 134 Mg^. Last Dose Prior To Sae On 08 June 2009) (View Docetaxel Review and Docetaxel Label ), CARBOPLATIN (Form Reported As Vials. Dosing Amount Reported As 6 Auc.) (View Carboplatin Review and Carboplatin Label ), CEFAZOLIN (View Cefazolin Review and Cefazolin Label ), LOVENOX (View Lovenox Review and Lovenox Label ), TORADOL (View Toradol Review and Toradol Label ), ATIVAN (View Ativan Review and Ativan Label ), ACETAMINOPHEN (View Acetaminophen Review and Acetaminophen Label ). Patient was hospitalized.

6936616-8 | Pericarditis
Adverse event was reported on Aug 12, 2010 by a Female patient taking Trastuzumab (View Usage) (Dosage: Dosage Form: 250 Ml Nacl.) was diagnosed with breast cancer (What is breast cancer?) and. Location: GERMANY , weighting 172.0 lb, After Trastuzumab was administered, patient had the following side effects: pericarditis. During the same period patient was treated with DOCETAXEL (View Docetaxel Review and Docetaxel Label ), CYCLOPHOSPHAMIDE (Dosage Form 500 Nacl) (View Cyclophosphamide Review and Cyclophosphamide Label ), EPIRUBICIN (Dosage Form 250ml Nacl) (View Epirubicin Review and Epirubicin Label ), INSULIN (View Insulin Review and Insulin Label ), LEVOTHYROXINE SODIUM (View Levothyroxine Sodium Review and Levothyroxine Sodium Label ), SIMVASTATIN (View Simvastatin Review and Simvastatin Label ). Patient was hospitalized.

6936612-0 | Chest Pain, Febrile Neutropenia
on Aug 10, 2010 Female patient from UNITED STATES , 54 years of age, weighting 130.1 lb, was treated with Trastuzumab (View Usage). Patient experienced the following unwanted or unexpected effects: chest pain (What is chest pain?), febrile neutropenia. Trastuzumab dosage: . During the same period patient was treated with BEVACIZUMAB (View Bevacizumab Review and Bevacizumab Label ), TAXOTERE (View Taxotere Review and Taxotere Label ). Patient was hospitalized.

6936585-0 | Hypokalaemia, Nausea, Neutrophil Count, White Blood Cell Count
on Aug 12, 2010 Female patient from UNITED STATES , weighting 176.4 lb, was diagnosed with breast cancer (What is breast cancer?) and was treated with Trastuzumab (View Usage). Patient had the following side effects: hypokalaemia, nausea (What is nausea?), neutrophil count, white blood cell count. Trastuzumab dosage: Loading Dose: 8 Mg/kg, Total Dose: 656 Mg, Form: Vials, Last Dose Prior To Sae: 14 July 2010.. During the same period patient was treated with DOCETAXEL (Form: Vials, Total Dose: 136 Mg, Last Dose Prior To Sae: 14 July 2010.) (View Docetaxel Review and Docetaxel Label ), CARBOPLATIN (Dose Level: 6, Units: Auc, Form: Vials, Last Dose Prior To Sae: 14 July 2010.) (View Carboplatin Review and Carboplatin Label ), LOVASTATIN (View Lovastatin Review and Lovastatin Label ), ASPIRIN (View Aspirin Review and Aspirin Label ), AMLODIPINE (View Amlodipine Review and Amlodipine Label ). Patient was hospitalized.

6933929-0 | Chest Pain
Patient was taking Trastuzumab (View Usage). After Trastuzumab was administered, patient had the following side effects: chest pain (What is chest pain?) on Aug 12, 2010 from UNITED STATES Additional patient health information: Female patient , weighting 274.9 lb, was diagnosed with breast cancer (What is breast cancer?) and. Trastuzumab dosage: . During the same period patient was treated with IXABEPILONE (View Ixabepilone Review and Ixabepilone Label ), CARBOPLATIN (View Carboplatin Review and Carboplatin Label ), COUMADIN (Daily) (View Coumadin Review and Coumadin Label ), LASIX (Daily, As Necesary) (View Lasix Review and Lasix Label ), NEURONTIN (Frequency: Qid) (View Neurontin Review and Neurontin Label ), OMEPRAZOLE (Daily) (View Omeprazole Review and Omeprazole Label ), OXYCODONE HCL AND ACETAMINOPHEN (Dose: 10/325, Frequency: Q6hrpm) (View Oxycodone Hcl And Acetaminophen Review and Oxycodone Hcl And Acetaminophen Label ), PAROXETINE HCL (Daily) (View Paroxetine Hcl Review and Paroxetine Hcl Label ). Patient was hospitalized.

6933894-6 | Capillary Leak Syndrome
Adverse event was reported on Aug 10, 2010 by a Female patient taking Trastuzumab (View Usage) (Dosage: Route Of Admin: Intravenous (not Otherwise Specified). Last Dose Prior To Sae: 06 July 2010) was diagnosed with breast cancer (What is breast cancer?) and. Location: UNITED STATES , weighting 127.9 lb, Patient experienced the following unwanted or unexpected effects: capillary leak syndrome. During the same period patient was treated with DOCETAXEL (Daily Dose: Unk (80 Mg). Last Dose Prior To Sae: 06 July 2010) (View Docetaxel Review and Docetaxel Label ), DOXORUBICIN HCL (Route: Intravenous Not Otherwise Specified. Doxorubicine (50 Mg). Last Dose: 04 May 2010.) (View Doxorubicin Hcl Review and Doxorubicin Hcl Label ), CYCLOPHOSPHAMIDE (Cyclophosphomide (100 Mg), Route : Intravenous Not Otherwise Specified. Last Dose: 04 May 2010) (View Cyclophosphamide Review and Cyclophosphamide Label ), FUROSEMIDE (Unk (40 Mg)) (View Furosemide Review and Furosemide Label ). Patient was hospitalized and became disabled.

6930344-0 | Myocardial Infarction
on Aug 12, 2010 Female patient from SOUTH AFRICA , weighting 209.0 lb, was treated with Trastuzumab (View Usage). Patient had the following side effects: myocardial infarction. Trastuzumab dosage: Form: Injection, Last Dose Prior To Sae: 27 July 2010.. During the same period patient was treated with DOCETAXEL (Form: Injection, Last Dose Prior To Sae: 27 July 2010.) (View Docetaxel Review and Docetaxel Label ), ATENOLOL (View Atenolol Review and Atenolol Label ), ALLOPURINOL (View Allopurinol Review and Allopurinol Label ), DEXAMETHASONE (View Dexamethasone Review and Dexamethasone Label ), ONDANSETRON (View Ondansetron Review and Ondansetron Label ), SUCRALFATE (View Sucralfate Review and Sucralfate Label ).

6928214-7 | Acute Polyneuropathy, Neutropenia
on Aug 09, 2010 Female patient from UNITED STATES , weighting 137.8 lb, was diagnosed with breast cancer (What is breast cancer?), nausea (What is nausea?), fear and was treated with Trastuzumab (View Usage). After Trastuzumab was administered, patient had the following side effects: acute polyneuropathy, neutropenia. Trastuzumab dosage: . During the same period patient was treated with DOXORUBICIN HCL (Form: Solution For Infusion.) (View Doxorubicin Hcl Review and Doxorubicin Hcl Label ), DOCETAXEL (Received 2 Cycles Of Docetaxel.) (View Docetaxel Review and Docetaxel Label ), CYCLOPHOSPHAMIDE (View Cyclophosphamide Review and Cyclophosphamide Label ), METOCLOPRAMIDE (View Metoclopramide Review and Metoclopramide Label ), LOPERAMIDE (View Loperamide Review and Loperamide Label ), LORAZEPAM (View Lorazepam Review and Lorazepam Label ). Patient was hospitalized.

6928187-7 | Alveolitis Fibrosing, Pneumonia, Respiratory Failure
Patient was taking Trastuzumab (View Usage). Patient experienced the following unwanted or unexpected effects: alveolitis fibrosing, pneumonia (What is pneumonia?), respiratory failure on Aug 11, 2010 from GERMANY Additional patient health information: Female patient , weighting 92.59 lb, was diagnosed with hypothyroidism, sleep disorder (What is sleep disorder?) and. Trastuzumab dosage: . During the same period patient was treated with PACLITAXEL (View Paclitaxel Review and Paclitaxel Label ), EFEROX (View Eferox Review and Eferox Label ), OPIPRAMOL (View Opipramol Review and Opipramol Label ). Patient was hospitalized.

6925498-6 | Cough, Dysphonia
Adverse event was reported on Aug 06, 2010 by a Female patient taking Trastuzumab (View Usage) (Dosage: Form:vials, Dose Level:8-6mg, Total Dose:586-439.8mg,last Dose Prior To Sae:25 Jun 2010) . Location: UNITED STATES , weighting 162.0 lb, Patient had the following side effects: cough, dysphonia. During the same period patient was treated with BEVACIZUMAB (Form, Vials, Date Of Last Dose Prior To Sae:25 June 2010) (View Bevacizumab Review and Bevacizumab Label ), CARBOPLATIN (Form: Vials, Dose Level 6auc, Total Dose 595-850 Mg, Last Dose Prior To Sae:4 Jun 2010) (View Carboplatin Review and Carboplatin Label ), DOCETAXEL (Form:vials, Total Dose 135 Mg, Last Dose Prior To Sae: 4 June 2010) (View Docetaxel Review and Docetaxel Label ), CELEXA (View Celexa Review and Celexa Label ), ATIVAN (View Ativan Review and Ativan Label ), PRILOSEC (View Prilosec Review and Prilosec Label ).

6923285-6 | Capillary Leak Syndrome
on Aug 05, 2010 Female patient from UNITED STATES , weighting 127.9 lb, was diagnosed with breast cancer (What is breast cancer?) and was treated with Trastuzumab (View Usage). After Trastuzumab was administered, patient had the following side effects: capillary leak syndrome. Trastuzumab dosage: Route Of Admin: Intravenous (not Otherwise Specified). During the same period patient was treated with DOCETAXEL (Daily Dose: Unk (80 Mg)) (View Docetaxel Review and Docetaxel Label ), FUROSEMIDE (Unk (40 Mg)) (View Furosemide Review and Furosemide Label ). Patient was hospitalized and became disabled.

6923239-X |
on Aug 05, 2010 Female patient from SOUTH AFRICA , weighting 209.0 lb, was treated with Trastuzumab (View Usage). . Trastuzumab dosage: Form: Injection, Last Dose Prior To Sae: 27 July 2010.. During the same period patient was treated with DOCETAXEL (Form: Injection, Last Dose Prior To Sae: 27 July 2010.) (View Docetaxel Review and Docetaxel Label ), ATENOLOL (View Atenolol Review and Atenolol Label ), ALLOPURINOL (View Allopurinol Review and Allopurinol Label ), DEXAMETHASONE (View Dexamethasone Review and Dexamethasone Label ), ONDANSETRON (View Ondansetron Review and Ondansetron Label ), CYCLIZINE (Frequency: Prn) (View Cyclizine Review and Cyclizine Label ).

6923210-8 | Cardiac Failure
Patient was taking Trastuzumab (View Usage). Patient had the following side effects: cardiac failure on Jul 30, 2010 from SWITZERLAND Additional patient health information: Female patient , weighting 143.3 lb, . Trastuzumab dosage: Loading Dose. During the same period patient was treated with PERTUZUMAB (Loading Dose.) (View Pertuzumab Review and Pertuzumab Label ), DOCETAXEL (Last Dose Prior To Sae 19 July 2010) (View Docetaxel Review and Docetaxel Label ), FLUOROURACIL (Last Dose Prior To Sae: 01 June 2010) (View Fluorouracil Review and Fluorouracil Label ), CYCLOPHOSPHAMIDE (Last Dose Prior To Sae:01 June 2010) (View Cyclophosphamide Review and Cyclophosphamide Label ), EPIRUBICIN (Last Dose Prior To Sae:01june 2010) (View Epirubicin Review and Epirubicin Label ). Patient was hospitalized.