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
125494021 12549402 1 I 20160627 20160712 20160712 EXP CZ-CORDEN PHARMA LATINA S.P.A.-CZ-2016COR000185 CORDEN MELICHAR B, LACO J, FRIDRICHOVA P, SIMKOVIC M, PAPAJIK T, FORETOVA L.. THERAPY-RELATED MYELOID NEOPLASMS IN EPITHELIAL OVARIAN CANCER PATIENTS CARRYING BRCA1 MUTATION. REPORT OF TWO CASES.. ACTA ONCOL.. 2012;51 (1):136-138 0.00 F Y 0.00000 20160712 OT CZ CZ

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
125494021 12549402 1 PS CARBOPLATIN. CARBOPLATIN 1 AUC 6 (17 CYCLES) 19880
125494021 12549402 2 SS CARBOPLATIN. CARBOPLATIN 1 AUC 6 19880
125494021 12549402 3 SS PACLITAXEL. PACLITAXEL 1 175 MG/M2, EVERY 3 WEEKS (6 CYCLES) 0 175 MG/M**2
125494021 12549402 4 SS PACLITAXEL. PACLITAXEL 1 175 MG/M2, (17 CYCLES) 0 175 MG/M**2
125494021 12549402 5 SS PACLITAXEL. PACLITAXEL 1 175 MG/M2, UNK 0 175 MG/M**2
125494021 12549402 6 SS TAMOXIFEN TAMOXIFEN 1 20 MG/DAY U 0
125494021 12549402 7 SS GEMCITABINE GEMCITABINEGEMCITABINE HYDROCHLORIDE 1 1 G/M2 EVERY 2 WEEKS 0
125494021 12549402 8 SS CISPLATIN. CISPLATIN 1 40 MG/M2, EVERY 2 WEEKS 0 40 MG/M**2
125494021 12549402 9 SS DOXORUBICIN DOXORUBICIN 1 50 MG/M2, EVERY 3 WEEKS (6 CYCLES) 0 50 MG/M**2
125494021 12549402 10 SS DOXORUBICIN DOXORUBICIN 1 0

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
125494021 12549402 1 Serous cystadenocarcinoma ovary
125494021 12549402 3 Serous cystadenocarcinoma ovary
125494021 12549402 4 Breast cancer
125494021 12549402 6 Serous cystadenocarcinoma ovary
125494021 12549402 7 Serous cystadenocarcinoma ovary
125494021 12549402 8 Serous cystadenocarcinoma ovary
125494021 12549402 9 Breast cancer
125494021 12549402 10 Serous cystadenocarcinoma ovary

Outcome of event

Event ID CASEID OUTC COD
125494021 12549402 OT

Reactions reported

Event ID CASEID DRUG REC ACT PT
125494021 12549402 Anaemia
125494021 12549402 Leukopenia
125494021 12549402 Myelodysplastic syndrome
125494021 12549402 Thrombocytopenia

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
125494021 12549402 2 200602 0
125494021 12549402 5 200602 0
125494021 12549402 7 200611 200703 0
125494021 12549402 8 200611 200703 0