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
125425351 12542535 1 I 20160624 20160709 20160709 EXP JP-CIPLA LTD.-2016JP09120 CIPLA 0.00 Y 0.00000 20160709 OT JP JP

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
125425351 12542535 1 PS GEMCITABINE GEMCITABINEGEMCITABINE HYDROCHLORIDE 1 Intravenous (not otherwise specified) 1000 MG/M2, OVER 30 MIN ON DAYS 1 AND 8 OF A 3-WEEK CYCLE U U 78759 1000 MG/M**2
125425351 12542535 2 SS OXALIPLATIN. OXALIPLATIN 1 130 MG/M2, ON DAY 1 AS A 2-HOUR INFUSION U U 0 130 MG/M**2 INFUSION
125425351 12542535 3 SS ETOPOSIDE. ETOPOSIDE 1 Unknown UNK 0
125425351 12542535 4 SS CISPLATIN. CISPLATIN 1 Unknown UNK 0
125425351 12542535 5 SS PACLITAXEL. PACLITAXEL 1 Unknown UNK 0
125425351 12542535 6 SS IFOSFAMIDE. IFOSFAMIDE 1 Unknown UNK 0
125425351 12542535 7 SS BLEOMYCIN BLEOMYCIN SULFATE 1 Unknown UNK 0
125425351 12542535 8 SS Nedaplatin NEDAPLATIN 1 Unknown UNK 0
125425351 12542535 9 C DEXAMETHASONE. DEXAMETHASONE 1 Unknown UNK U U 0

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
125425351 12542535 1 Testicular germ cell cancer
125425351 12542535 2 Testicular germ cell cancer
125425351 12542535 3 Testicular germ cell cancer
125425351 12542535 4 Testicular germ cell cancer
125425351 12542535 5 Testicular germ cell cancer
125425351 12542535 6 Testicular germ cell cancer
125425351 12542535 7 Testicular germ cell cancer
125425351 12542535 8 Testicular germ cell cancer

Outcome of event

Event ID CASEID OUTC COD
125425351 12542535 OT
125425351 12542535 DE

Reactions reported

Event ID CASEID DRUG REC ACT PT
125425351 12542535 Disease progression
125425351 12542535 Refractory cancer

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

no results found

Therapies reported

no results found