The Safety Rates Drug Report

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Drug     Injury     Quarter    

Person who experienced the adverse event (patient)

Event ID CASEID CASEVERSION I F COD EVENT DT MFR DT INIT FDA DT FDA DT REPT COD AUTH NUM MFR NUM MFR SNDR LIT REF AGE AGE COD AGE GRP GNDR COD E SUB WT WT COD REPT DT TO MFR OCCP COD REPORTER COUNTRY OCCR COUNTRY
127986121 12798612 1 I 20110325 20110611 20160930 20160930 EXP US-ROCHE-784343 ROCHE 62.00 YR F Y 71.60000 KG 20160930 MD US US

Drug(s) used by person

Event ID CASEID DRUG SEQ ROLE COD DRUGNAME PROD AI VAL VBM ROUTE DOSE VBM CUM DOSE CHR CUM DOSE UNIT DECHAL RECHAL LOT NUM EXP DT NDA NUM DOSE AMT DOSE UNIT DOSE FORM DOSE FREQ
127986121 12798612 1 PS Bevacizumab BEVACIZUMAB 1 Intravenous (not otherwise specified) OVER 30-90 MINUTES ON DAY 1. DATE OF LAST DOSE PRIOR TO SAE: 23 MARCH 2011, DOSE OF BEVACIZUMAB (108 N 125085 15 MG/KG
127986121 12798612 2 SS PACLITAXEL. PACLITAXEL 1 Intravenous (not otherwise specified) OVER 3 HRS ON DAY 1X 6 CYCLES. DATE OF LAST DOSE PRIOR TO SAE 23 MARCH 2011 N 0 175 MG/M**2
127986121 12798612 3 SS CARBOPLATIN. CARBOPLATIN 1 Intravenous (not otherwise specified) AUC 6 OVER 30 MINUTES ON DAY 1 N 0

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
127986121 12798612 1 Endometrial adenocarcinoma
127986121 12798612 2 Endometrial adenocarcinoma
127986121 12798612 3 Endometrial adenocarcinoma

Outcome of event

Event ID CASEID OUTC COD
127986121 12798612 LT
127986121 12798612 OT
127986121 12798612 HO

Reactions reported

Event ID CASEID DRUG REC ACT PT
127986121 12798612 Abdominal pain
127986121 12798612 Acidosis
127986121 12798612 Anaemia
127986121 12798612 Blood alkaline phosphatase increased
127986121 12798612 Cough
127986121 12798612 Dehydration
127986121 12798612 Diarrhoea
127986121 12798612 Dyspnoea
127986121 12798612 Fatigue
127986121 12798612 Haemoglobin decreased
127986121 12798612 Hyperglycaemia
127986121 12798612 Hypoalbuminaemia
127986121 12798612 Hypocalcaemia
127986121 12798612 Hypokalaemia
127986121 12798612 Hyponatraemia
127986121 12798612 Large intestine perforation
127986121 12798612 Lymphocyte count decreased
127986121 12798612 Lymphopenia
127986121 12798612 Neutrophil count decreased
127986121 12798612 Rectal haemorrhage
127986121 12798612 Sepsis
127986121 12798612 Stomatitis
127986121 12798612 Urinary tract infection
127986121 12798612 White blood cell count decreased

Reporting Sources (this data is often not reported and may therefore be missing here)

no results found

Therapies reported

Event ID CASEID DSG DRUG SEQ START DT END DT DUR DUR COD
127986121 12798612 2 20110323 0
127986121 12798612 3 20110323 0