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
125287671 12528767 1 I 20160628 20160705 20160705 EXP JP-CELGENEUS-JPN-2016066800 CELGENE OKUMA Y. TITLE: A PHASE II STUDY OF NANOPARTICLE ALBUMIN-BOUND PACLITAXEL PLUS CARBOPLATIN AS THE FIRST-LINE THERAPY IN ELDERLY PATIENTS WITH PREVIOUSLY UNTREATED ADVANCED NON-SMALL CELL LUNG CANCER.. CANCER CHEMOTHER PHARMACOL.. 2016 JUN 23;. 0.00 E Y 0.00000 20160705 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
125287671 12528767 1 PS ABRAXANE PACLITAXEL 1 Intravenous drip 100 MILLIGRAM/SQ. METER U 21660 100 MG/M**2 INJECTION FOR INFUSION
125287671 12528767 2 SS CARBOPLATIN. CARBOPLATIN 1 Unknown AUC 6 U 0 UNKNOWN
125287671 12528767 3 SS CARBOPLATIN. CARBOPLATIN 1 Unknown AUC 5 U 0 UNKNOWN
125287671 12528767 4 C DEXAMETHASONE. DEXAMETHASONE 1 Unknown 0 6.6 MG UNKNOWN
125287671 12528767 5 C Palonosetron PALONOSETRON 1 Unknown 0 .75 MG UNKNOWN

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
125287671 12528767 1 Non-small cell lung cancer
125287671 12528767 2 Non-small cell lung cancer
125287671 12528767 4 Product used for unknown indication
125287671 12528767 5 Product used for unknown indication

Outcome of event

Event ID CASEID OUTC COD
125287671 12528767 DE
125287671 12528767 OT

Reactions reported

Event ID CASEID DRUG REC ACT PT
125287671 12528767 Acute respiratory failure
125287671 12528767 Anaemia
125287671 12528767 Death
125287671 12528767 Febrile neutropenia
125287671 12528767 Lung infection
125287671 12528767 Sepsis

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

no results found

Therapies reported

no results found