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
125909511 12590951 1 I 20111214 20120114 20160726 20160726 EXP US-ROCHE-1031080 ROCHE 63.00 YR M Y 99.80000 KG 20160726 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
125909511 12590951 1 PS Vismodegib VISMODEGIB 1 Oral TOTAL DOSE ADMINISTERED 150 MG, LAST DOSE PRIOR TO SAE 14 DEC 2011. U 203388 150 MG CAPSULE QD
125909511 12590951 2 SS Vismodegib VISMODEGIB 1 Oral U 203388 1000 MG CAPSULE QD
125909511 12590951 3 SS Vismodegib VISMODEGIB 1 Oral U 203388 1000 MG CAPSULE
125909511 12590951 4 SS Vismodegib VISMODEGIB 1 Oral U 203388 500 MG CAPSULE
125909511 12590951 5 SS Vismodegib VISMODEGIB 1 Oral U 203388 1000 MG CAPSULE
125909511 12590951 6 SS Vismodegib VISMODEGIB 1 Oral U 203388 1000 MG CAPSULE
125909511 12590951 7 SS Vismodegib VISMODEGIB 1 Oral U 203388 1000 MG CAPSULE
125909511 12590951 8 SS Vismodegib VISMODEGIB 1 Oral U 203388 1000 MG CAPSULE
125909511 12590951 9 SS Vismodegib VISMODEGIB 1 Oral U 203388 1000 MG CAPSULE
125909511 12590951 10 SS Vismodegib VISMODEGIB 1 Oral U 203388 1000 MG CAPSULE
125909511 12590951 11 SS GEMCITABINE HYDROCHLORIDE. GEMCITABINE HYDROCHLORIDE 1 Intravenous (not otherwise specified) TOTAL DOSE ADMINISTERED 2400 MG, LAST DOSE PRIOR TO SAE 14 DEC 2011. U 0 1000 MG/M**2
125909511 12590951 12 SS GEMCITABINE HYDROCHLORIDE. GEMCITABINE HYDROCHLORIDE 1 Intravenous (not otherwise specified) U 0 750 MG
125909511 12590951 13 SS GEMCITABINE HYDROCHLORIDE. GEMCITABINE HYDROCHLORIDE 1 Intravenous (not otherwise specified) U 0 1000 MG
125909511 12590951 14 SS GEMCITABINE HYDROCHLORIDE. GEMCITABINE HYDROCHLORIDE 1 Intravenous (not otherwise specified) U 0 1000 MG
125909511 12590951 15 SS GEMCITABINE HYDROCHLORIDE. GEMCITABINE HYDROCHLORIDE 1 Intravenous (not otherwise specified) U 0 500 MG
125909511 12590951 16 SS GEMCITABINE HYDROCHLORIDE. GEMCITABINE HYDROCHLORIDE 1 Intravenous (not otherwise specified) U 0 1000 MG
125909511 12590951 17 SS GEMCITABINE HYDROCHLORIDE. GEMCITABINE HYDROCHLORIDE 1 Intravenous (not otherwise specified) U 0 750 MG
125909511 12590951 18 SS GEMCITABINE HYDROCHLORIDE. GEMCITABINE HYDROCHLORIDE 1 Intravenous (not otherwise specified) U 0 750 MG
125909511 12590951 19 SS GEMCITABINE HYDROCHLORIDE. GEMCITABINE HYDROCHLORIDE 1 Intravenous (not otherwise specified) U 0 1000 MG
125909511 12590951 20 SS GEMCITABINE HYDROCHLORIDE. GEMCITABINE HYDROCHLORIDE 1 Intravenous (not otherwise specified) U 0 1000 MG
125909511 12590951 21 SS GEMCITABINE HYDROCHLORIDE. GEMCITABINE HYDROCHLORIDE 1 Intravenous (not otherwise specified) U 0 1000 MG
125909511 12590951 22 SS GEMCITABINE HYDROCHLORIDE. GEMCITABINE HYDROCHLORIDE 1 Intravenous (not otherwise specified) U 0 1000 MG
125909511 12590951 23 SS GEMCITABINE HYDROCHLORIDE. GEMCITABINE HYDROCHLORIDE 1 Intravenous (not otherwise specified) U 0 1000 MG
125909511 12590951 24 SS GEMCITABINE HYDROCHLORIDE. GEMCITABINE HYDROCHLORIDE 1 Intravenous (not otherwise specified) U 0 1000 MG

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
125909511 12590951 1 Pancreatic carcinoma
125909511 12590951 11 Pancreatic carcinoma

Outcome of event

Event ID CASEID OUTC COD
125909511 12590951 HO
125909511 12590951 DE
125909511 12590951 OT

Reactions reported

Event ID CASEID DRUG REC ACT PT
125909511 12590951 Anaemia
125909511 12590951 Biliary tract infection
125909511 12590951 Cholangitis
125909511 12590951 Death
125909511 12590951 Lymphocyte count decreased
125909511 12590951 Neutrophil count decreased
125909511 12590951 Platelet count decreased
125909511 12590951 Syncope
125909511 12590951 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
125909511 12590951 1 20110404 0
125909511 12590951 2 20110531 0
125909511 12590951 3 20110627 0
125909511 12590951 4 20110725 0
125909511 12590951 5 20110822 0
125909511 12590951 6 20110919 0
125909511 12590951 7 20111017 0
125909511 12590951 8 20120111 0
125909511 12590951 9 20110208 0
125909511 12590951 10 20110305 0
125909511 12590951 11 20110404 0
125909511 12590951 12 20110502 0
125909511 12590951 13 20110531 0
125909511 12590951 14 20110627 0
125909511 12590951 15 20110725 0
125909511 12590951 16 20110822 0
125909511 12590951 17 20110919 0
125909511 12590951 18 20111017 0
125909511 12590951 19 20111116 0
125909511 12590951 20 20111214 0
125909511 12590951 21 20120111 0
125909511 12590951 22 20110208 0
125909511 12590951 23 20110305 0
125909511 12590951 24 20120411 0

Execution Time: 0.0082008838653564 seconds (ucode:5160682). Developed by: James D. Barger

 


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