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
127560771 12756077 1 I 20160906 20160916 20160916 EXP ES-MYLANLABS-2016M1038181 MYLAN VALERA RUBIO M, LABRADOR ANDUJAR N, RUBIO SALVADOR AR, CHACON LOPEZ-MUNIZ JI, DIAZ PANIAGUA L. PHARMACOLOGICAL APPROACH FOR THE MANAGEMENT OF ADRENOCORTICAL CARCINOMA: A CASE REPORT. EUR-J-CLIN-PHAM 2016;18(3):199-201. 0.00 Y 0.00000 20160916 OT ES ES

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
127560771 12756077 1 PS CAPECITABINE. CAPECITABINE 1 Unknown 800 MG U U 90943
127560771 12756077 2 SS CISPLATIN. CISPLATIN 1 Unknown 50 MG/M2 ON DAY 1 U 0
127560771 12756077 3 SS CISPLATIN. CISPLATIN 1 Unknown 100 MG/M2 ON DAY 1 U 0
127560771 12756077 4 SS DOXORUBICIN DOXORUBICIN 1 Unknown 50 MG/M2 ON DAY 1, EVERY 21 DAYS U 0
127560771 12756077 5 SS ETOPOSIDE. ETOPOSIDE 1 Unknown 100 MG/M2 ON DAYS 1, 2 ,3, EVERY 21 DAYS U U 0
127560771 12756077 6 SS GEMCITABINE GEMCITABINEGEMCITABINE HYDROCHLORIDE 1 Unknown 800 MG/M2 U U 0
127560771 12756077 7 SS IFOSFAMIDE. IFOSFAMIDE 1 Unknown 2000 MG/M2 U U 0
127560771 12756077 8 SS LIPOSOMAL DOXORUBICIN HCL DOXORUBICIN HYDROCHLORIDE 1 Other 20 MG/M2 ON DAY 1, EVERY 21 DAYS U U 0
127560771 12756077 9 SS LIPOSOMAL DOXORUBICIN HCL DOXORUBICIN HYDROCHLORIDE 1 Other 50 MG/M2 ON DAY 1, EVERY 21 DAYS U U 0
127560771 12756077 10 SS FILGRASTIM FILGRASTIM 1 Unknown 300 MCG, 5 DAYS U U 0
127560771 12756077 11 C MESNA. MESNA 1 Unknown 2000 MG/M2 ON DAYS 1-3 U U 0

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
127560771 12756077 1 Adrenocortical carcinoma
127560771 12756077 2 Adrenocortical carcinoma
127560771 12756077 4 Adrenocortical carcinoma
127560771 12756077 5 Adrenocortical carcinoma
127560771 12756077 6 Adrenocortical carcinoma
127560771 12756077 7 Adrenocortical carcinoma
127560771 12756077 8 Adrenocortical carcinoma
127560771 12756077 10 Adrenocortical carcinoma
127560771 12756077 11 Adrenocortical carcinoma

Outcome of event

Event ID CASEID OUTC COD
127560771 12756077 OT

Reactions reported

Event ID CASEID DRUG REC ACT PT
127560771 12756077 Blood creatinine abnormal
127560771 12756077 Cystitis haemorrhagic
127560771 12756077 Gastroenteritis
127560771 12756077 Hyperadrenocorticism
127560771 12756077 Mucosal inflammation
127560771 12756077 Pancytopenia
127560771 12756077 Pyrexia

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
127560771 12756077 1 201206 0
127560771 12756077 2 200909 0
127560771 12756077 4 200909 0
127560771 12756077 6 201206 0
127560771 12756077 7 201012 0
127560771 12756077 8 201012 0
127560771 12756077 9 201203 0
127560771 12756077 11 201012 0