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
873635436 8736354 36 F 201111 20160810 20120822 20160817 EXP CA-ROCHE-1023790 ROCHE 39.72 YR M Y 0.00000 20160817 OT CA CA

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
873635436 8736354 1 PS XOLAIR OMALIZUMAB 1 Subcutaneous U S0060A,S0062,S0065E,S0068D 103976 225 MG SOLUTION FOR INJECTION QOW
873635436 8736354 2 SS XOLAIR OMALIZUMAB 1 Subcutaneous U S0060A,S0062,S0065E,S0068D 103976 225 MG SOLUTION FOR INJECTION QOW
873635436 8736354 3 SS XOLAIR OMALIZUMAB 1 Subcutaneous U S0060A,S0062,S0065E,S0068D 103976 SOLUTION FOR INJECTION
873635436 8736354 4 SS XOLAIR OMALIZUMAB 1 Subcutaneous U S0060A,S0062,S0065E,S0068D 103976 SOLUTION FOR INJECTION
873635436 8736354 5 SS XOLAIR OMALIZUMAB 1 Subcutaneous U S0060A,S0062,S0065E,S0068D 103976 SOLUTION FOR INJECTION
873635436 8736354 6 SS XOLAIR OMALIZUMAB 1 Subcutaneous U S0060A,S0062,S0065E,S0068D 103976 SOLUTION FOR INJECTION
873635436 8736354 7 SS XOLAIR OMALIZUMAB 1 Subcutaneous U S0060A,S0062,S0065E,S0068D 103976 SOLUTION FOR INJECTION
873635436 8736354 8 SS XOLAIR OMALIZUMAB 1 Subcutaneous U S0060A,S0062,S0065E,S0068D 103976 SOLUTION FOR INJECTION
873635436 8736354 9 SS XOLAIR OMALIZUMAB 1 Subcutaneous U S0060A,S0062,S0065E,S0068D 103976 SOLUTION FOR INJECTION
873635436 8736354 10 SS XOLAIR OMALIZUMAB 1 Subcutaneous U S0060A,S0062,S0065E,S0068D 103976 SOLUTION FOR INJECTION
873635436 8736354 11 SS XOLAIR OMALIZUMAB 1 Subcutaneous U S0060A,S0062,S0065E,S0068D 103976 SOLUTION FOR INJECTION
873635436 8736354 12 SS XOLAIR OMALIZUMAB 1 Subcutaneous U S0060A,S0062,S0065E,S0068D 103976 SOLUTION FOR INJECTION
873635436 8736354 13 SS XOLAIR OMALIZUMAB 1 Subcutaneous U S0060A,S0062,S0065E,S0068D 103976 SOLUTION FOR INJECTION
873635436 8736354 14 SS XOLAIR OMALIZUMAB 1 Subcutaneous U S0060A,S0062,S0065E,S0068D 103976 SOLUTION FOR INJECTION
873635436 8736354 15 SS XOLAIR OMALIZUMAB 1 Subcutaneous U S0060A,S0062,S0065E,S0068D 103976 SOLUTION FOR INJECTION
873635436 8736354 16 SS XOLAIR OMALIZUMAB 1 Subcutaneous U S0060A,S0062,S0065E,S0068D 103976 SOLUTION FOR INJECTION
873635436 8736354 17 SS XOLAIR OMALIZUMAB 1 Subcutaneous U S0060A,S0062,S0065E,S0068D 103976 SOLUTION FOR INJECTION
873635436 8736354 18 SS XOLAIR OMALIZUMAB 1 Subcutaneous U S0060A,S0062,S0065E,S0068D 103976 SOLUTION FOR INJECTION
873635436 8736354 19 SS XOLAIR OMALIZUMAB 1 Subcutaneous U S0060A,S0062,S0065E,S0068D 103976 SOLUTION FOR INJECTION
873635436 8736354 20 SS XOLAIR OMALIZUMAB 1 Subcutaneous U S0060A,S0062,S0065E,S0068D 103976 SOLUTION FOR INJECTION
873635436 8736354 21 SS XOLAIR OMALIZUMAB 1 Subcutaneous U S0060A,S0062,S0065E,S0068D 103976 SOLUTION FOR INJECTION
873635436 8736354 22 SS XOLAIR OMALIZUMAB 1 Subcutaneous U S0060A,S0062,S0065E,S0068D 103976 SOLUTION FOR INJECTION
873635436 8736354 23 SS XOLAIR OMALIZUMAB 1 Subcutaneous U S0060A,S0062,S0065E,S0068D 103976 SOLUTION FOR INJECTION
873635436 8736354 24 SS XOLAIR OMALIZUMAB 1 Subcutaneous U S0060A,S0062,S0065E,S0068D 103976 SOLUTION FOR INJECTION
873635436 8736354 25 SS XOLAIR OMALIZUMAB 1 Subcutaneous U S0060A,S0062,S0065E,S0068D 103976 SOLUTION FOR INJECTION
873635436 8736354 26 SS XOLAIR OMALIZUMAB 1 Subcutaneous U S0060A,S0062,S0065E,S0068D 103976 SOLUTION FOR INJECTION
873635436 8736354 27 SS XOLAIR OMALIZUMAB 1 Subcutaneous U S0060A,S0062,S0065E,S0068D 103976 SOLUTION FOR INJECTION
873635436 8736354 28 SS XOLAIR OMALIZUMAB 1 Subcutaneous U S0060A,S0062,S0065E,S0068D 103976 SOLUTION FOR INJECTION
873635436 8736354 29 SS XOLAIR OMALIZUMAB 1 Subcutaneous U S0060A,S0062,S0065E,S0068D 103976 SOLUTION FOR INJECTION
873635436 8736354 30 SS XOLAIR OMALIZUMAB 1 Subcutaneous U S0060A,S0062,S0065E,S0068D 103976 SOLUTION FOR INJECTION
873635436 8736354 31 SS XOLAIR OMALIZUMAB 1 Subcutaneous U S0060A,S0062,S0065E,S0068D 103976 SOLUTION FOR INJECTION
873635436 8736354 32 SS XOLAIR OMALIZUMAB 1 Subcutaneous U S0060A,S0062,S0065E,S0068D 103976 SOLUTION FOR INJECTION
873635436 8736354 33 SS XOLAIR OMALIZUMAB 1 Subcutaneous U S0060A,S0062,S0065E,S0068D 103976 SOLUTION FOR INJECTION
873635436 8736354 34 SS XOLAIR OMALIZUMAB 1 Subcutaneous U S0060A,S0062,S0065E,S0068D 103976 SOLUTION FOR INJECTION
873635436 8736354 35 SS XOLAIR OMALIZUMAB 1 Subcutaneous U S0060A,S0062,S0065E,S0068D 103976 SOLUTION FOR INJECTION
873635436 8736354 36 SS XOLAIR OMALIZUMAB 1 Subcutaneous U S0060A,S0062,S0065E,S0068D 103976 SOLUTION FOR INJECTION
873635436 8736354 37 SS XOLAIR OMALIZUMAB 1 Subcutaneous U S0060A,S0062,S0065E,S0068D 103976 SOLUTION FOR INJECTION
873635436 8736354 38 SS XOLAIR OMALIZUMAB 1 Subcutaneous U S0060A,S0062,S0065E,S0068D 103976 SOLUTION FOR INJECTION
873635436 8736354 39 SS XOLAIR OMALIZUMAB 1 Subcutaneous U S0060A,S0062,S0065E,S0068D 103976 SOLUTION FOR INJECTION
873635436 8736354 40 SS XOLAIR OMALIZUMAB 1 Subcutaneous U S0060A,S0062,S0065E,S0068D 103976 SOLUTION FOR INJECTION
873635436 8736354 41 SS XOLAIR OMALIZUMAB 1 Subcutaneous U S0060A,S0062,S0065E,S0068D 103976 SOLUTION FOR INJECTION
873635436 8736354 42 SS XOLAIR OMALIZUMAB 1 Subcutaneous U S0060A,S0062,S0065E,S0068D 103976 SOLUTION FOR INJECTION
873635436 8736354 43 SS XOLAIR OMALIZUMAB 1 Subcutaneous U S0060A,S0062,S0065E,S0068D 103976 SOLUTION FOR INJECTION
873635436 8736354 44 SS XOLAIR OMALIZUMAB 1 Subcutaneous U S0060A,S0062,S0065E,S0068D 103976 SOLUTION FOR INJECTION
873635436 8736354 45 SS XOLAIR OMALIZUMAB 1 Subcutaneous U S0060A,S0062,S0065E,S0068D 103976 SOLUTION FOR INJECTION
873635436 8736354 46 SS XOLAIR OMALIZUMAB 1 Subcutaneous U S0060A,S0062,S0065E,S0068D 103976 SOLUTION FOR INJECTION
873635436 8736354 47 SS XOLAIR OMALIZUMAB 1 Subcutaneous U S0060A,S0062,S0065E,S0068D 103976 SOLUTION FOR INJECTION
873635436 8736354 48 SS XOLAIR OMALIZUMAB 1 Subcutaneous U S0060A,S0062,S0065E,S0068D 103976 SOLUTION FOR INJECTION
873635436 8736354 49 SS XOLAIR OMALIZUMAB 1 Subcutaneous U S0060A,S0062,S0065E,S0068D 103976 SOLUTION FOR INJECTION
873635436 8736354 50 SS XOLAIR OMALIZUMAB 1 Subcutaneous U S0060A,S0062,S0065E,S0068D 103976 SOLUTION FOR INJECTION
873635436 8736354 51 SS XOLAIR OMALIZUMAB 1 Subcutaneous U S0060A,S0062,S0065E,S0068D 103976 SOLUTION FOR INJECTION
873635436 8736354 52 SS XOLAIR OMALIZUMAB 1 Subcutaneous U S0060A,S0062,S0065E,S0068D 103976 SOLUTION FOR INJECTION
873635436 8736354 53 SS PREDNISONE. PREDNISONE 1 Oral U NOT REPORTED 0 10 MG QD
873635436 8736354 54 SS PREDNISONE. PREDNISONE 1 Unknown U NOT REPORTED 0 50 MG
873635436 8736354 55 SS PREDNISONE. PREDNISONE 1 Unknown U NOT REPORTED 0
873635436 8736354 56 SS PREDNISONE. PREDNISONE 1 Unknown U NOT REPORTED 0
873635436 8736354 57 C SYMBICORT BUDESONIDEFORMOTEROL FUMARATE DIHYDRATE 1 Unknown (2 PUFFS) 0 2 DF QD
873635436 8736354 58 C SYMBICORT BUDESONIDEFORMOTEROL FUMARATE DIHYDRATE 1 Unknown (8 PUFFS) 0 8 DF QD
873635436 8736354 59 C SPIRIVA TIOTROPIUM BROMIDE MONOHYDRATE 1 Unknown U 0
873635436 8736354 60 C RHINOCORT BUDESONIDE 1 Unknown U 0
873635436 8736354 61 C VENTOLIN ALBUTEROL SULFATE 1 Unknown 100 UG, UNK U 0 100 UG
873635436 8736354 62 C VENTOLIN ALBUTEROL SULFATE 1 Unknown PRN (EVERY 1 HOUR AS NEEDED) U 0
873635436 8736354 63 C SINGULAIR MONTELUKAST SODIUM 1 Unknown U 0

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
873635436 8736354 1 Asthma
873635436 8736354 53 Productive cough
873635436 8736354 57 Product used for unknown indication
873635436 8736354 59 Product used for unknown indication
873635436 8736354 60 Product used for unknown indication
873635436 8736354 61 Dyspnoea
873635436 8736354 63 Product used for unknown indication

Outcome of event

Event ID CASEID OUTC COD
873635436 8736354 OT

Reactions reported

Event ID CASEID DRUG REC ACT PT
873635436 8736354 Asthma
873635436 8736354 Blood pressure increased
873635436 8736354 Body temperature decreased
873635436 8736354 Cough
873635436 8736354 Dyspnoea
873635436 8736354 Environmental exposure
873635436 8736354 Fall
873635436 8736354 Forced expiratory volume decreased
873635436 8736354 Heart rate increased
873635436 8736354 Hypoventilation
873635436 8736354 Influenza
873635436 8736354 Lower respiratory tract infection
873635436 8736354 Middle insomnia
873635436 8736354 Nasal congestion
873635436 8736354 Nasopharyngitis
873635436 8736354 Productive cough
873635436 8736354 Rales
873635436 8736354 Respiratory distress
873635436 8736354 Road traffic accident
873635436 8736354 Throat irritation
873635436 8736354 Wrist fracture

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
873635436 8736354 1 20110902 0
873635436 8736354 2 20120411 0
873635436 8736354 3 20121206 0
873635436 8736354 4 20130212 0
873635436 8736354 5 20130326 0
873635436 8736354 6 20130422 0
873635436 8736354 7 20130604 0
873635436 8736354 8 20130618 0
873635436 8736354 9 20130731 0
873635436 8736354 10 20130827 0
873635436 8736354 11 20120815 0
873635436 8736354 12 20130409 0
873635436 8736354 13 20130521 0
873635436 8736354 14 20130813 0
873635436 8736354 15 20130909 0
873635436 8736354 16 20130924 0
873635436 8736354 17 20131008 0
873635436 8736354 18 20131022 0
873635436 8736354 19 20131119 0
873635436 8736354 20 20131227 0
873635436 8736354 21 20140122 0
873635436 8736354 22 20140219 0
873635436 8736354 23 20140305 0
873635436 8736354 24 20140528 20140528 0
873635436 8736354 25 20140611 0
873635436 8736354 26 20140625 0
873635436 8736354 27 20140806 0
873635436 8736354 28 20140820 0
873635436 8736354 29 20141029 0
873635436 8736354 30 20141112 0
873635436 8736354 31 20141209 0
873635436 8736354 32 20150107 0
873635436 8736354 33 20150121 0
873635436 8736354 34 20150204 0
873635436 8736354 35 20150218 0
873635436 8736354 36 20150304 0
873635436 8736354 37 20150505 0
873635436 8736354 38 20150617 0
873635436 8736354 39 20150812 0
873635436 8736354 40 20150909 0
873635436 8736354 41 20150923 0
873635436 8736354 42 20151007 0
873635436 8736354 43 20151024 0
873635436 8736354 44 20151112 0
873635436 8736354 45 20151216 0
873635436 8736354 46 20151230 0
873635436 8736354 47 20160113 0
873635436 8736354 48 20160309 0
873635436 8736354 49 20160406 0
873635436 8736354 50 20160420 0
873635436 8736354 51 20160518 0
873635436 8736354 52 20160726 0
873635436 8736354 57 2012 0
873635436 8736354 61 2012 0