The Safety Rates Drug Report

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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
127053871 12705387 1 I 20160826 20160901 20160901 EXP AU-AMGEN-AUSCT2016113205 AMGEN R.L O^CONNELL. TACTIC: A MULTICENTRE, OPEN-LABEL, SINGLE-ARM PHASE II TRIAL OF PANITUMUMAB, CISPLATIN, AND GEMCITABINE IN BILIARY TRACT CANCER.. CANCER CHEMOTHER PHARMACOL.. 2016;78:361-367 0.00 Y 0.00000 20160831 OT AU AU

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
127053871 12705387 1 PS panitumumab PANITUMUMAB 1 Unknown 9 MG/KG, ON DAY 1 OF EACH CYCLE U 125147 9 MG/KG UNKNOWN FORMULATION
127053871 12705387 2 SS GEMCITABINE GEMCITABINEGEMCITABINE HYDROCHLORIDE 1 Unknown 1000 MG/M2 ON DAY 1 AND DAY 8 OF EACH 21-DAY CYCLE 0 1000 MG/M**2
127053871 12705387 3 SS CISPLATIN. CISPLATIN 1 Unknown 25 MG/M2, ON DAY AND DAY 8 OF EACH 21-DAY CYCLE 0 25 MG/M**2

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
127053871 12705387 1 Bile duct cancer
127053871 12705387 2 Bile duct cancer
127053871 12705387 3 Bile duct cancer

Outcome of event

Event ID CASEID OUTC COD
127053871 12705387 OT
127053871 12705387 DE

Reactions reported

Event ID CASEID DRUG REC ACT PT
127053871 12705387 Febrile neutropenia

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

no results found

Therapies reported

no results found