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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
122708876 12270887 6 F 20160210 20160916 20160415 20160920 EXP FR-ROCHE-1738942 ROCHE 64.00 YR M Y 78.00000 KG 20160920 MD FR FR

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
122708876 12270887 1 PS Obinutuzumab OBINUTUZUMAB 1 Intravenous (not otherwise specified) 25 MG, CYCLE 1 DAY 1, TEMPORARILY INTERRUPTED?1000 MG SPLIT DOSE ON CYCLE 1, DAY 1 AND DAY 2. 1145797 125486 25 MG SOLUTION FOR INFUSION
122708876 12270887 2 SS Obinutuzumab OBINUTUZUMAB 1 Intravenous (not otherwise specified) CYCLE 1 DAY 2?1000 MG SPLIT DOSE ON CYCLE 1, DAY 1 AND DAY 2. 1145797 125486 975 MG SOLUTION FOR INFUSION
122708876 12270887 3 SS Obinutuzumab OBINUTUZUMAB 1 Intravenous (not otherwise specified) CYCLE 1 DAY 8 1145797 125486 1000 MG SOLUTION FOR INFUSION
122708876 12270887 4 SS Obinutuzumab OBINUTUZUMAB 1 Intravenous (not otherwise specified) CYCLE 1 DAY 15 1145797 125486 1000 MG SOLUTION FOR INFUSION
122708876 12270887 5 SS Obinutuzumab OBINUTUZUMAB 1 Intravenous (not otherwise specified) CYCLE 2 DAY 1 1145797 125486 1000 MG SOLUTION FOR INFUSION
122708876 12270887 6 SS Obinutuzumab OBINUTUZUMAB 1 Intravenous (not otherwise specified) CYCLE 3 DAY 1 1145797 125486 1000 MG SOLUTION FOR INFUSION
122708876 12270887 7 SS Obinutuzumab OBINUTUZUMAB 1 Intravenous (not otherwise specified) CYCLE 4 DAY 1 1145797 125486 1000 MG SOLUTION FOR INFUSION
122708876 12270887 8 SS Obinutuzumab OBINUTUZUMAB 1 Intravenous (not otherwise specified) CYCLE 5 DAY 1 1145797 125486 1000 MG SOLUTION FOR INFUSION
122708876 12270887 9 SS Obinutuzumab OBINUTUZUMAB 1 Intravenous (not otherwise specified) CYCLE 6 DAY 1?THIS WAS THE LAST DOSE PRIOR TO SAE 16/SEP/2014 1145797 125486 1000 MG SOLUTION FOR INFUSION
122708876 12270887 10 SS FLUDARABINE FLUDARABINE PHOSPHATE 1 Oral CYCLE 1 DAY 1?LAST DOSE PRIOR TO SAE ON 18/SEP/2014 0 40 MG/M**2 TABLET QD
122708876 12270887 11 SS FLUDARABINE FLUDARABINE PHOSPHATE 1 Oral CYCLE 1 DAY 2 0 40 MG/M**2 TABLET QD
122708876 12270887 12 SS FLUDARABINE FLUDARABINE PHOSPHATE 1 Oral CYCLE 1 DAY 3 0 40 MG/M**2 TABLET QD
122708876 12270887 13 SS FLUDARABINE FLUDARABINE PHOSPHATE 1 Oral CYCLE 2 DAY 1 0 40 MG/M**2 TABLET QD
122708876 12270887 14 SS FLUDARABINE FLUDARABINE PHOSPHATE 1 Oral CYCLE 2 DAY 3 0 40 MG/M**2 TABLET QD
122708876 12270887 15 SS FLUDARABINE FLUDARABINE PHOSPHATE 1 Oral CYCLE 3 DAY 1 0 40 MG/M**2 TABLET QD
122708876 12270887 16 SS FLUDARABINE FLUDARABINE PHOSPHATE 1 Oral CYCLE 3 DAY 2 0 40 MG/M**2 TABLET QD
122708876 12270887 17 SS FLUDARABINE FLUDARABINE PHOSPHATE 1 Oral CYCLE 3 DAY 3 0 40 MG/M**2 TABLET QD
122708876 12270887 18 SS FLUDARABINE FLUDARABINE PHOSPHATE 1 Oral CYCLE 4, 0 30 MG/M**2 TABLET QD
122708876 12270887 19 SS FLUDARABINE FLUDARABINE PHOSPHATE 1 Oral CYCLE 5, ON DAY 1 AND 2 0 30 MG/M**2 TABLET QD
122708876 12270887 20 SS FLUDARABINE FLUDARABINE PHOSPHATE 1 Oral CYCLE 5, ON DAY 3 0 30 MG/M**2 TABLET QD
122708876 12270887 21 SS FLUDARABINE FLUDARABINE PHOSPHATE 1 Oral CYCLE 6, ON DAY 1,2 AND 3?MOST RECENT DOSE PRIOR TO SAE: 18/SEP/2014 0 30 MG/M**2 TABLET QD
122708876 12270887 22 SS CYCLOPHOSPHAMIDE. CYCLOPHOSPHAMIDE 1 Oral LAST DOSE PRIOR TO SAE ON 18/SEP/2014?CYCLE 1 ON DAY 1,2 AND 3 0 250 MG/M**2 TABLET QD
122708876 12270887 23 SS CYCLOPHOSPHAMIDE. CYCLOPHOSPHAMIDE 1 Oral CYCLE 2 ON DAY 1,2 AND 3 0 250 MG/M**2 TABLET QD
122708876 12270887 24 SS CYCLOPHOSPHAMIDE. CYCLOPHOSPHAMIDE 1 Oral CYCLE 3 ON DAY 1,2 AND 3 0 250 MG/M**2 TABLET QD
122708876 12270887 25 SS CYCLOPHOSPHAMIDE. CYCLOPHOSPHAMIDE 1 Oral CYCLE 4 ON DAY 1,2 AND 3 0 187.5 MG/M**2 TABLET QD
122708876 12270887 26 SS CYCLOPHOSPHAMIDE. CYCLOPHOSPHAMIDE 1 Oral CYCLE 5 ON DAY 1,2 AND 3 0 187.5 MG/M**2 TABLET QD
122708876 12270887 27 SS CYCLOPHOSPHAMIDE. CYCLOPHOSPHAMIDE 1 Oral CYCLE 6 ON DAY 1,2 AND 3.?MOST RECENT DOSE ON 18/SEP/2014 0 250 MG/M**2 TABLET QD
122708876 12270887 28 C POLARAMINE DEXCHLORPHENIRAMINE MALEATE 1 Intravenous (not otherwise specified) BEFORE EACH OBINUTUZUMAB ADMINISATRATION 0 5 MG
122708876 12270887 29 C POLARAMINE DEXCHLORPHENIRAMINE MALEATE 1 Intravenous (not otherwise specified) BEFORE EACH OBINUTUZUMAB ADMINISATRATION 0 5 MG
122708876 12270887 30 C PARACETAMOL ACETAMINOPHEN 1 Oral BEFORE EACH OBINUTUZUMAB ADMINISATRATION 0 1 G
122708876 12270887 31 C METHYLPREDNISOLONE. METHYLPREDNISOLONE 1 Intravenous (not otherwise specified) BEFORE EACH OBINUTUZUMAB ADMINISATRATION 0 80 MG
122708876 12270887 32 C FASTURTEC RASBURICASE 1 Intravenous (not otherwise specified) 0 7.5 MG QD
122708876 12270887 33 C SOLU-MEDROL METHYLPREDNISOLONE SODIUM SUCCINATE 1 Intravenous (not otherwise specified) 0 40 MG BID
122708876 12270887 34 C CALCIUM GLUCONATE. CALCIUM GLUCONATE 1 Intravenous (not otherwise specified) 0 1 G QD
122708876 12270887 35 C PRIMPERAN METOCLOPRAMIDE HYDROCHLORIDE 1 Oral 0 10 MG BID
122708876 12270887 36 C ZELITREX VALACYCLOVIR HYDROCHLORIDE 1 Oral 0 500 MG BID
122708876 12270887 37 C LEDERFOLINE LEUCOVORIN CALCIUM 1 Oral 0 25 MG BIW
122708876 12270887 38 C AUGMENTIN AMOXICILLINCLAVULANATE POTASSIUM 1 Oral 0 1 G TID
122708876 12270887 39 C CIFLOX (FRANCE) CIPROFLOXACIN 1 Oral 0 500 MG BID
122708876 12270887 40 C ZOLPIDEM ZOLPIDEMOLPIDEM TARTRATE 1 Oral 0 10 MG QD
122708876 12270887 41 C ZYLORIC ALLOPURINOL 1 Oral 0 300 MG QD
122708876 12270887 42 C LORATADINE. LORATADINE 1 Oral 0 10 MG QD
122708876 12270887 43 C EMEND APREPITANT 1 Oral 0 125 MG QD
122708876 12270887 44 C ONDANSETRON ONDANSETRON 1 Intravenous (not otherwise specified) 0 16 MG QD
122708876 12270887 45 C CLARITYNE LORATADINE 1 Oral ONE TABLET 0 16 MG QD
122708876 12270887 46 C HIZENTRA HUMAN IMMUNOGLOBULIN G 1 Subcutaneous 0 10 G /wk

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
122708876 12270887 1 Chronic lymphocytic leukaemia
122708876 12270887 10 Chronic lymphocytic leukaemia
122708876 12270887 22 Chronic lymphocytic leukaemia
122708876 12270887 46 Infection prophylaxis

Outcome of event

Event ID CASEID OUTC COD
122708876 12270887 HO

Reactions reported

Event ID CASEID DRUG REC ACT PT
122708876 12270887 Interstitial lung disease

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
122708876 12270887 1 20140415 20140415 0
122708876 12270887 2 20140416 20140416 0
122708876 12270887 3 20140423 20140423 0
122708876 12270887 4 20140430 20140430 0
122708876 12270887 5 20140514 20140514 0
122708876 12270887 6 20140617 20140617 0
122708876 12270887 7 20140722 20140722 0
122708876 12270887 8 20140819 20140819 0
122708876 12270887 9 20140916 0
122708876 12270887 10 20140417 20140417 0
122708876 12270887 11 20140418 20140418 0
122708876 12270887 12 20140419 20140419 0
122708876 12270887 13 20140515 20140515 0
122708876 12270887 14 20140516 20140516 0
122708876 12270887 15 20140618 20140618 0
122708876 12270887 16 20140619 20140619 0
122708876 12270887 17 20140620 20140620 0
122708876 12270887 18 20140723 20140725 0
122708876 12270887 19 20140820 20140821 0
122708876 12270887 20 20140822 20140822 0
122708876 12270887 21 20140916 0
122708876 12270887 22 20140417 20140419 0
122708876 12270887 23 20140515 20140518 0
122708876 12270887 24 20140618 20140620 0
122708876 12270887 25 20140723 20140725 0
122708876 12270887 26 20140820 20140822 0
122708876 12270887 27 20140916 0
122708876 12270887 28 20140415 20140916 0
122708876 12270887 29 20140416 20140416 0
122708876 12270887 30 20140415 20140416 0
122708876 12270887 31 20140415 20140916 0
122708876 12270887 32 20140415 20140416 0
122708876 12270887 33 20140415 20140415 0
122708876 12270887 34 20140416 20140416 0
122708876 12270887 35 20140416 20140423 0
122708876 12270887 36 20140416 0
122708876 12270887 37 20140416 0
122708876 12270887 38 20140715 20140722 0
122708876 12270887 39 20140715 20140722 0
122708876 12270887 40 20140825 20140826 0
122708876 12270887 41 20140408 20140414 0
122708876 12270887 42 20140916 20140916 0
122708876 12270887 43 20140819 20140819 0
122708876 12270887 44 20140819 20140819 0
122708876 12270887 45 20140917 20140919 0
122708876 12270887 46 20160425 0

Execution Time: 0.0056600570678711 seconds (ucode:5236471). Developed by: James D. Barger

 


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