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
1127058019 11270580 19 F 2014 20160921 20150714 20160927 EXP PHHY2014CA025312 SANDOZ 45.92 YR M Y 0.00000 20160927 CN COUNTRY NOT SPECIFIED 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
1127058019 11270580 1 SS XOLAIR OMALIZUMAB 1 Subcutaneous 375 MG, BIW (EVERY 2 WEEKS) U 0 375 MG VIAL QOW
1127058019 11270580 2 SS XOLAIR OMALIZUMAB 1 Subcutaneous UNK U 0 VIAL
1127058019 11270580 3 SS XOLAIR OMALIZUMAB 1 Subcutaneous UNK U 0 VIAL
1127058019 11270580 4 SS XOLAIR OMALIZUMAB 1 Subcutaneous UNK U 0 VIAL
1127058019 11270580 5 SS XOLAIR OMALIZUMAB 1 Subcutaneous UNK U 0 VIAL
1127058019 11270580 6 SS XOLAIR OMALIZUMAB 1 Subcutaneous UNK U 0 VIAL
1127058019 11270580 7 SS XOLAIR OMALIZUMAB 1 Subcutaneous UNK U 0 VIAL
1127058019 11270580 8 SS XOLAIR OMALIZUMAB 1 Subcutaneous UNK U 0 VIAL
1127058019 11270580 9 SS XOLAIR OMALIZUMAB 1 Subcutaneous UNK U 0 VIAL
1127058019 11270580 10 SS XOLAIR OMALIZUMAB 1 Subcutaneous UNK U 0 VIAL
1127058019 11270580 11 SS XOLAIR OMALIZUMAB 1 Subcutaneous UNK U 0 VIAL
1127058019 11270580 12 SS XOLAIR OMALIZUMAB 1 Subcutaneous UNK U 0 VIAL
1127058019 11270580 13 SS XOLAIR OMALIZUMAB 1 Subcutaneous UNK U 0 VIAL
1127058019 11270580 14 SS XOLAIR OMALIZUMAB 1 Subcutaneous UNK U 0 VIAL
1127058019 11270580 15 SS XOLAIR OMALIZUMAB 1 Subcutaneous UNK U 0 VIAL
1127058019 11270580 16 SS XOLAIR OMALIZUMAB 1 Subcutaneous UNK U 0 VIAL
1127058019 11270580 17 SS XOLAIR OMALIZUMAB 1 Subcutaneous UNK U 0 VIAL
1127058019 11270580 18 SS XOLAIR OMALIZUMAB 1 Subcutaneous UNK U 0 VIAL
1127058019 11270580 19 SS XOLAIR OMALIZUMAB 1 Subcutaneous UNK U 0 VIAL
1127058019 11270580 20 SS XOLAIR OMALIZUMAB 1 Subcutaneous UNK U 0 VIAL
1127058019 11270580 21 SS XOLAIR OMALIZUMAB 1 Subcutaneous UNK U S0059B 0 VIAL
1127058019 11270580 22 SS XOLAIR OMALIZUMAB 1 Subcutaneous UNK U S0062 0 VIAL
1127058019 11270580 23 SS XOLAIR OMALIZUMAB 1 Subcutaneous UNK U S0062/S0065E 0 VIAL
1127058019 11270580 24 SS XOLAIR OMALIZUMAB 1 Subcutaneous UNK U S0060/S0065E 0 VIAL
1127058019 11270580 25 SS XOLAIR OMALIZUMAB 1 Subcutaneous UNK U S0065E 0 VIAL
1127058019 11270580 26 SS XOLAIR OMALIZUMAB 1 Subcutaneous UNK U S0066B 0 VIAL
1127058019 11270580 27 SS XOLAIR OMALIZUMAB 1 Subcutaneous UNK U S0001E 0 VIAL
1127058019 11270580 28 SS XOLAIR OMALIZUMAB 1 Subcutaneous UNK U S0068D 0 VIAL
1127058019 11270580 29 SS XOLAIR OMALIZUMAB 1 Subcutaneous UNK U S0002F 0 VIAL
1127058019 11270580 30 SS XOLAIR OMALIZUMAB 1 Subcutaneous UNK U S0068D 0 VIAL
1127058019 11270580 31 SS XOLAIR OMALIZUMAB 1 Subcutaneous UNK U S0003C 0 VIAL
1127058019 11270580 32 SS XOLAIR OMALIZUMAB 1 Subcutaneous UNK U S0068D 0 VIAL
1127058019 11270580 33 SS XOLAIR OMALIZUMAB 1 Subcutaneous UNK U 0 VIAL
1127058019 11270580 34 PS PREDNISONE. PREDNISONE 1 Unknown 80336
1127058019 11270580 35 SS PREDNISONE. PREDNISONE 1 Unknown 25 MG, QD 80336 25 MG QD
1127058019 11270580 36 SS PREDNISONE. PREDNISONE 1 Unknown 5 MG, QW 80336 5 MG /wk
1127058019 11270580 37 SS PREDNISONE. PREDNISONE 1 Unknown 20 MG, QD 80336 20 MG QD
1127058019 11270580 38 SS PREDNISONE. PREDNISONE 1 Unknown 35 MG, QD 80336 35 MG QD
1127058019 11270580 39 SS PREDNISONE. PREDNISONE 1 Unknown 20 MG, UNK 80336 20 MG
1127058019 11270580 40 SS PREDNISONE. PREDNISONE 1 Unknown 25 MG, QD (TAPERED TO 20 MG OVER 2 WEEKS AND THEN TO 10 MG) 80336 25 MG QD
1127058019 11270580 41 SS PREDNISONE. PREDNISONE 1 Oral UNK 80336
1127058019 11270580 42 C ADVAIR HFA FLUTICASONE PROPIONATESALMETEROL XINAFOATE 1 Unknown U 0
1127058019 11270580 43 C ALVESCO CICLESONIDE 1 Unknown U 0
1127058019 11270580 44 C SPIRIVA TIOTROPIUM BROMIDE MONOHYDRATE 1 Unknown U 0
1127058019 11270580 45 C SINGULAIR MONTELUKAST SODIUM 1 Unknown U 0

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
1127058019 11270580 1 Asthma
1127058019 11270580 34 Wheezing
1127058019 11270580 35 Cough
1127058019 11270580 36 Throat tightness
1127058019 11270580 42 Product used for unknown indication
1127058019 11270580 43 Product used for unknown indication
1127058019 11270580 44 Product used for unknown indication
1127058019 11270580 45 Product used for unknown indication

Outcome of event

Event ID CASEID OUTC COD
1127058019 11270580 OT

Reactions reported

Event ID CASEID DRUG REC ACT PT
1127058019 11270580 Arthralgia
1127058019 11270580 Asthma
1127058019 11270580 Blood pressure increased
1127058019 11270580 Body temperature decreased
1127058019 11270580 Bronchitis
1127058019 11270580 Chest pain
1127058019 11270580 Cough
1127058019 11270580 Decreased appetite
1127058019 11270580 Dizziness
1127058019 11270580 Dizziness postural
1127058019 11270580 Dyspnoea exertional
1127058019 11270580 Erythema
1127058019 11270580 Fall
1127058019 11270580 Fractured coccyx
1127058019 11270580 Gait disturbance
1127058019 11270580 Gastroenteritis viral
1127058019 11270580 Headache
1127058019 11270580 Heart rate increased
1127058019 11270580 Heart rate irregular
1127058019 11270580 Herpes zoster
1127058019 11270580 Malaise
1127058019 11270580 Migraine
1127058019 11270580 Neck pain
1127058019 11270580 Oxygen saturation decreased
1127058019 11270580 Pneumonia
1127058019 11270580 Respiratory rate increased
1127058019 11270580 Respiratory tract irritation
1127058019 11270580 Rib fracture
1127058019 11270580 Sneezing
1127058019 11270580 Sputum discoloured
1127058019 11270580 Swelling
1127058019 11270580 Throat tightness
1127058019 11270580 Weight decreased
1127058019 11270580 Wheezing

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
1127058019 11270580 1 20140227 0
1127058019 11270580 2 20140326 0
1127058019 11270580 3 20140409 0
1127058019 11270580 4 20140521 0
1127058019 11270580 5 20140604 0
1127058019 11270580 6 20140702 0
1127058019 11270580 7 20140716 0
1127058019 11270580 8 20140813 0
1127058019 11270580 9 20140827 0
1127058019 11270580 10 20141217 0
1127058019 11270580 11 20141230 0
1127058019 11270580 12 20150114 0
1127058019 11270580 13 20150129 0
1127058019 11270580 14 20150225 0
1127058019 11270580 15 20150311 0
1127058019 11270580 16 20150325 0
1127058019 11270580 17 20150506 0
1127058019 11270580 18 20150603 0
1127058019 11270580 19 20150715 0
1127058019 11270580 20 20151202 0
1127058019 11270580 21 20160127 0
1127058019 11270580 22 20160224 0
1127058019 11270580 23 20160309 0
1127058019 11270580 24 20160323 0
1127058019 11270580 25 20160504 0
1127058019 11270580 26 20160518 0
1127058019 11270580 27 20160601 0
1127058019 11270580 28 20160615 0
1127058019 11270580 29 20160629 0
1127058019 11270580 30 20160713 0
1127058019 11270580 31 20160825 0
1127058019 11270580 32 20160907 0
1127058019 11270580 33 20160921 0
1127058019 11270580 35 20140627 0
1127058019 11270580 37 20140827 0
1127058019 11270580 38 20141022 0
1127058019 11270580 39 20150426 0