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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
1039125211 10391252 11 F 20130830 20160805 20140818 20160815 EXP JP-ALEXION PHARMACEUTICALS INC.-A201403064 ALEXION 4.00 MON F Y 8.50000 KG 20160815 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
1039125211 10391252 1 PS SOLIRIS ECULIZUMAB 1 Intravenous (not otherwise specified) 150 MG, SINGLE 125166 150 MG CONCENTRATE FOR SOLUTION FOR INFUSION QD
1039125211 10391252 2 SS SOLIRIS ECULIZUMAB 1 Intravenous (not otherwise specified) 300 MG, SINGLE 125166 300 MG CONCENTRATE FOR SOLUTION FOR INFUSION QD
1039125211 10391252 3 SS SOLIRIS ECULIZUMAB 1 Intravenous (not otherwise specified) 300 MG, SINGLE 125166 300 MG CONCENTRATE FOR SOLUTION FOR INFUSION QD
1039125211 10391252 4 SS SOLIRIS ECULIZUMAB 1 Intravenous (not otherwise specified) 160 MG, SINGLE 125166 160 MG CONCENTRATE FOR SOLUTION FOR INFUSION QD
1039125211 10391252 5 SS SOLIRIS ECULIZUMAB 1 Intravenous (not otherwise specified) 300 MG, Q3W AB6695B01 125166 300 MG CONCENTRATE FOR SOLUTION FOR INFUSION
1039125211 10391252 6 SS SOLIRIS ECULIZUMAB 1 Intravenous (not otherwise specified) 300 MG, UNK AC4114B01 125166 300 MG CONCENTRATE FOR SOLUTION FOR INFUSION
1039125211 10391252 7 SS SOLIRIS ECULIZUMAB 1 Intravenous (not otherwise specified) 300 MG, UNK AC4114B02 125166 300 MG CONCENTRATE FOR SOLUTION FOR INFUSION
1039125211 10391252 8 SS SOLIRIS ECULIZUMAB 1 Intravenous (not otherwise specified) 300 MG, Q2W AC6839D01 125166 300 MG CONCENTRATE FOR SOLUTION FOR INFUSION QOW
1039125211 10391252 9 SS SOLIRIS ECULIZUMAB 1 Intravenous (not otherwise specified) 300 MG, Q2W AC6841D01 125166 300 MG CONCENTRATE FOR SOLUTION FOR INFUSION QOW
1039125211 10391252 10 SS SOLIRIS ECULIZUMAB 1 Intravenous (not otherwise specified) 300 MG, Q2W AD6547B01 125166 300 MG CONCENTRATE FOR SOLUTION FOR INFUSION QOW
1039125211 10391252 11 C LONGES LISINOPRIL 1 Oral 1 MG, QD 116 MG 0 1 MG QD
1039125211 10391252 12 C LONGES LISINOPRIL 1 Oral 0.7 MG, QD 116 MG 0 .7 MG QD
1039125211 10391252 13 C LONGES LISINOPRIL 1 Oral 0.5 MG, QD 116 MG 0 .5 MG QD
1039125211 10391252 14 C AMLODIPINE AMLODIPINE BESYLATE 1 Oral 0.75 MG, BID 207 MG 0 .75 MG BID
1039125211 10391252 15 C AMLODIPINE AMLODIPINE BESYLATE 1 Oral 0.75 MG, QD 207 MG 0 .75 MG QD
1039125211 10391252 16 C DIOVAN VALSARTAN 1 Oral 1 MG, QD 138 MG 0 1 MG QD
1039125211 10391252 17 C ALFAROL ALFACALCIDOL 1 Oral UNK UNK, QD 2.4000001 UG 0 QD
1039125211 10391252 18 C WASSER V 2 Oral 0.07 G, QD 0 .07 G QD
1039125211 10391252 19 C INCREMIN /00023544/ 2 Oral UNK UNK, BID 2632 ML 0
1039125211 10391252 20 C L CARTIN FF LEVOCARNITINE 1 Oral 0.4 ML, QD 100.400002 ML 0 .4 ML QD
1039125211 10391252 21 C L CARTIN FF LEVOCARNITINE 1 Oral 0.2 ML, QD 100.400002 ML 0 .2 ML QD
1039125211 10391252 22 C SODIUM VALPROATE VALPROATE SODIUM 1 Oral UNK UNK, TID 0 TID
1039125211 10391252 23 C POTASSIUM CHLORIDE. POTASSIUM CHLORIDE 1 Oral 0.2-0.4G, ONCE OR TWICE PER DAY 0
1039125211 10391252 24 C LAC-B BIFIDOBACTERIUM SPP. 1 Oral 0.5 G, TID 0 .5 G TID
1039125211 10391252 25 C GENOTROPIN SOMATROPIN 1 Subcutaneous 0.2-0.6MG, QD TO 6TH PER WEEK 0
1039125211 10391252 26 C NESP DARBEPOETIN ALFA 1 Subcutaneous 60-120 MCG, Q2W 0
1039125211 10391252 27 C ATARAX-P /00058402/ HYDROXYZINE HYDROCHLORIDE 1 Intravenous drip 2 MG, BEFORE SOLIRIS INFUSION 0 2 MG
1039125211 10391252 28 C METHYLPREDNISOLONE. METHYLPREDNISOLONE 1 Intravenous drip 4 MG, BEFORE SOLIRIS INFUSION 0 4 MG
1039125211 10391252 29 C METHYLPREDNISOLONE. METHYLPREDNISOLONE 1 Intravenous drip 6 MG, BEFORE SOLIRIS INFUSION 0 6 MG

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
1039125211 10391252 1 Haemolytic uraemic syndrome
1039125211 10391252 11 Haemolytic uraemic syndrome
1039125211 10391252 14 Haemolytic uraemic syndrome
1039125211 10391252 16 Haemolytic uraemic syndrome
1039125211 10391252 17 Haemolytic uraemic syndrome
1039125211 10391252 18 Haemolytic uraemic syndrome
1039125211 10391252 19 Haemolytic uraemic syndrome
1039125211 10391252 20 Haemolytic uraemic syndrome
1039125211 10391252 22 Epilepsy
1039125211 10391252 23 Haemolytic uraemic syndrome
1039125211 10391252 24 Haemolytic uraemic syndrome
1039125211 10391252 25 Haemolytic uraemic syndrome
1039125211 10391252 26 Haemolytic uraemic syndrome
1039125211 10391252 27 Prophylaxis
1039125211 10391252 28 Prophylaxis

Outcome of event

Event ID CASEID OUTC COD
1039125211 10391252 OT
1039125211 10391252 LT
1039125211 10391252 HO
1039125211 10391252 DS

Reactions reported

Event ID CASEID DRUG REC ACT PT
1039125211 10391252 Acinetobacter infection
1039125211 10391252 Anaphylactoid reaction
1039125211 10391252 Catheter site infection
1039125211 10391252 Corynebacterium infection
1039125211 10391252 Cough
1039125211 10391252 Diarrhoea
1039125211 10391252 Drug ineffective
1039125211 10391252 Infusion related reaction
1039125211 10391252 Laryngeal stenosis
1039125211 10391252 Peritonitis
1039125211 10391252 Pseudomonas infection
1039125211 10391252 Pyrexia
1039125211 10391252 Rash
1039125211 10391252 Seizure
1039125211 10391252 Sepsis
1039125211 10391252 Staphylococcal infection

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
1039125211 10391252 1 20130830 20130830 0
1039125211 10391252 2 20130906 20130906 0
1039125211 10391252 3 20130913 20130913 0
1039125211 10391252 4 20131014 20131014 0
1039125211 10391252 5 20131022 0
1039125211 10391252 7 20150522 0
1039125211 10391252 8 20150612 0
1039125211 10391252 11 20140826 20150321 0
1039125211 10391252 12 20150322 20150521 0
1039125211 10391252 13 20150522 0
1039125211 10391252 14 20140226 20141029 0
1039125211 10391252 15 20141030 20150303 0
1039125211 10391252 16 20140226 20141029 0
1039125211 10391252 17 20140710 0
1039125211 10391252 18 20131024 0
1039125211 10391252 19 20140107 0
1039125211 10391252 20 20131105 20141112 0
1039125211 10391252 21 20141113 20141128 0
1039125211 10391252 22 20150412 20150412 0
1039125211 10391252 23 20140723 0
1039125211 10391252 24 20140115 0
1039125211 10391252 25 20141021 0
1039125211 10391252 26 20141212 0
1039125211 10391252 27 20130830 0
1039125211 10391252 28 20130830 20130830 0
1039125211 10391252 29 20130906 0

Execution Time: 0.0062861442565918 seconds (ucode:5268758). Developed by: James D. Barger

 


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