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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
1170290915 11702909 15 F 20150318 20160803 20151105 20160812 EXP GB-ALEXION PHARMACEUTICALS INC-A201500796 ALEXION 62.28 YR M Y 0.00000 20160812 OT 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
1170290915 11702909 1 PS SOLIRIS ECULIZUMAB 1 Intravenous (not otherwise specified) UNK 125166 CONCENTRATE FOR SOLUTION FOR INFUSION
1170290915 11702909 2 SS SOLIRIS ECULIZUMAB 1 Intravenous (not otherwise specified) 1500 MG, Q2W P0003601 125166 1500 MG CONCENTRATE FOR SOLUTION FOR INFUSION QOW
1170290915 11702909 3 SS SOLIRIS ECULIZUMAB 1 Intravenous (not otherwise specified) 1200 MG, Q2W P14SOL501 125166 1200 MG CONCENTRATE FOR SOLUTION FOR INFUSION QOW
1170290915 11702909 4 SS SOLIRIS ECULIZUMAB 1 Intravenous (not otherwise specified) 1200 MG, Q2W 00027C 125166 1200 MG CONCENTRATE FOR SOLUTION FOR INFUSION QOW
1170290915 11702909 5 SS SOLIRIS ECULIZUMAB 1 Intravenous (not otherwise specified) 1500 MG, Q2W P0003601 125166 1500 MG CONCENTRATE FOR SOLUTION FOR INFUSION QOW
1170290915 11702909 6 SS SOLIRIS ECULIZUMAB 1 Intravenous (not otherwise specified) 1500 MG, Q2W P0003704 125166 1500 MG CONCENTRATE FOR SOLUTION FOR INFUSION QOW
1170290915 11702909 7 SS SOLIRIS ECULIZUMAB 1 Intravenous (not otherwise specified) 1500 MG, Q2W P0003801 125166 1500 MG CONCENTRATE FOR SOLUTION FOR INFUSION QOW
1170290915 11702909 8 SS SOLIRIS ECULIZUMAB 1 Intravenous (not otherwise specified) 1500 MG, Q2W P0004002 125166 1500 MG CONCENTRATE FOR SOLUTION FOR INFUSION QOW
1170290915 11702909 9 SS SOLIRIS ECULIZUMAB 1 Intravenous (not otherwise specified) 1500 MG, Q2W P0004002 125166 1500 MG CONCENTRATE FOR SOLUTION FOR INFUSION QOW
1170290915 11702909 10 SS SOLIRIS ECULIZUMAB 1 Intravenous (not otherwise specified) 1500 MG, Q2W P0003704 125166 1500 MG CONCENTRATE FOR SOLUTION FOR INFUSION QOW
1170290915 11702909 11 SS SOLIRIS ECULIZUMAB 1 Intravenous (not otherwise specified) 1500 MG, Q2W P0004102 125166 1500 MG CONCENTRATE FOR SOLUTION FOR INFUSION QOW
1170290915 11702909 12 SS SOLIRIS ECULIZUMAB 1 Intravenous (not otherwise specified) 1500 MG, Q2W P0004202 125166 1500 MG CONCENTRATE FOR SOLUTION FOR INFUSION QOW
1170290915 11702909 13 SS SOLIRIS ECULIZUMAB 1 Intravenous (not otherwise specified) 1500 MG, Q2W P0004707 125166 1500 MG CONCENTRATE FOR SOLUTION FOR INFUSION QOW
1170290915 11702909 14 SS SOLIRIS ECULIZUMAB 1 Intravenous (not otherwise specified) 1500 MG, Q2W P0005002R 125166 1500 MG CONCENTRATE FOR SOLUTION FOR INFUSION QOW
1170290915 11702909 15 SS SOLIRIS ECULIZUMAB 1 Intravenous (not otherwise specified) 1500 MG, Q2W P0004801 125166 1500 MG CONCENTRATE FOR SOLUTION FOR INFUSION QOW
1170290915 11702909 16 C VITAMIN D /00107901/ ERGOCALCIFEROL 1 Oral UNK 0
1170290915 11702909 17 C VITAMIN D /00107901/ ERGOCALCIFEROL 1 Oral 1000 IU, QD 0 1000 IU QD

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
1170290915 11702909 1 Paroxysmal nocturnal haemoglobinuria
1170290915 11702909 16 Product used for unknown indication

Outcome of event

Event ID CASEID OUTC COD
1170290915 11702909 OT

Reactions reported

Event ID CASEID DRUG REC ACT PT
1170290915 11702909 Arthralgia
1170290915 11702909 Blood urine present
1170290915 11702909 Breakthrough pain
1170290915 11702909 Chest discomfort
1170290915 11702909 Chromaturia
1170290915 11702909 Condition aggravated
1170290915 11702909 Cough
1170290915 11702909 Depressed mood
1170290915 11702909 Dysphagia
1170290915 11702909 Dyspnoea
1170290915 11702909 Dyspnoea exertional
1170290915 11702909 Fatigue
1170290915 11702909 Haemolysis
1170290915 11702909 Hypoaesthesia
1170290915 11702909 Incorrect dose administered
1170290915 11702909 Insomnia
1170290915 11702909 Lethargy
1170290915 11702909 Malaise
1170290915 11702909 Meningioma
1170290915 11702909 Musculoskeletal pain
1170290915 11702909 Nasopharyngitis
1170290915 11702909 Oropharyngeal pain
1170290915 11702909 Pain
1170290915 11702909 Pain in extremity
1170290915 11702909 Somnolence
1170290915 11702909 Tooth 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
1170290915 11702909 2 20080116 0
1170290915 11702909 3 20120820 0
1170290915 11702909 5 20080116 0
1170290915 11702909 6 20080116 0
1170290915 11702909 7 20080116 0
1170290915 11702909 8 20080116 0
1170290915 11702909 9 20080116 0
1170290915 11702909 10 20080116 0
1170290915 11702909 11 20080116 0
1170290915 11702909 12 20080116 0
1170290915 11702909 13 20080116 0
1170290915 11702909 14 20080116 0
1170290915 11702909 15 20080116 0

Execution Time: 0.0051360130310059 seconds (ucode:5267481). Developed by: James D. Barger

 


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