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
127175711 12717571 1 I 20151027 20151027 20160906 20160906 EXP GB-JNJFOC-20151022917 PHARMACYCLICS 61.15 YR A F Y 57.80000 KG 20160906 MD GB GB

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
127175711 12717571 1 PS IBRUTINIB IBRUTINIB 1 Oral N N 205552 CAPSULE
127175711 12717571 2 SS IBRUTINIB IBRUTINIB 1 Oral N N 102688 560 MG CAPSULE QD
127175711 12717571 3 SS RITUXIMAB RITUXIMAB 1 Intravenous (not otherwise specified) 0 375 MG/M**2 CONCENTRATE FOR SOLUTION FOR INFUSION
127175711 12717571 4 SS CYCLOPHOSPHAMIDE. CYCLOPHOSPHAMIDE 1 Intravenous (not otherwise specified) 0 562.5 MG/M**2 POWDER FOR INJECTION
127175711 12717571 5 SS DOXORUBICIN DOXORUBICIN 1 Intravenous (not otherwise specified) 0 37.5 MG/M**2 SOLUTION
127175711 12717571 6 SS VINCRISTINE VINCRISTINE 1 Intravenous (not otherwise specified) 0 .7 MG/M**2 SOLUTION
127175711 12717571 7 SS PREDNISOLONE. PREDNISOLONE 1 Oral DAY 1-5 (ALSO REPORTED AS 50 MG PER DAY). 0 80 MG TABLET
127175711 12717571 8 C ORAMORPH MORPHINE SULFATE 1 0

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
127175711 12717571 2 Diffuse large B-cell lymphoma
127175711 12717571 3 Diffuse large B-cell lymphoma
127175711 12717571 4 Diffuse large B-cell lymphoma
127175711 12717571 5 Diffuse large B-cell lymphoma
127175711 12717571 6 Diffuse large B-cell lymphoma
127175711 12717571 7 Diffuse large B-cell lymphoma
127175711 12717571 8 Oral pain

Outcome of event

Event ID CASEID OUTC COD
127175711 12717571 OT
127175711 12717571 LT
127175711 12717571 HO
127175711 12717571 DE

Reactions reported

Event ID CASEID DRUG REC ACT PT
127175711 12717571 Arteriosclerosis coronary artery
127175711 12717571 Diffuse alveolar damage
127175711 12717571 Interstitial lung disease
127175711 12717571 Pulmonary embolism

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
127175711 12717571 2 20150630 20151027 0
127175711 12717571 3 20150630 0
127175711 12717571 4 20150630 0
127175711 12717571 5 20150630 0
127175711 12717571 6 20150630 0
127175711 12717571 7 20150630 0