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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
122818533 | 12281853 | 3 | F | 20140708 | 20160725 | 20160419 | 20160801 | EXP | JP-ALEXION-A201501222 | ALEXION | 65.00 | YR | M | Y | 76.00000 | KG | 20160801 | MD | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
122818533 | 12281853 | 1 | PS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 600 MG, QW | 125166 | 600 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | /wk | ||||||
122818533 | 12281853 | 2 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 900 MG, Q2W | A90993D01 | 125166 | 900 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | |||||
122818533 | 12281853 | 3 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 900 MG, Q2W | AB6695B01 | 125166 | 900 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | |||||
122818533 | 12281853 | 4 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 900 MG, Q2W | AD6547B01 | 125166 | 900 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | |||||
122818533 | 12281853 | 5 | SS | SOLIRIS | ECULIZUMAB | 1 | UNK | 125166 | CONCENTRATE FOR SOLUTION FOR INFUSION | ||||||||||
122818533 | 12281853 | 6 | C | ENDOXAN /00021101/ | CYCLOPHOSPHAMIDE | 1 | Unknown | 100 MG, DAILY | 21100 | MG | 0 | 100 | MG | QD | |||||
122818533 | 12281853 | 7 | C | BACTRAMIN | SULFAMETHOXAZOLETRIMETHOPRIM | 1 | Oral | 1 DF, TIW | 0 | TABLET | TIW | ||||||||
122818533 | 12281853 | 8 | C | TRAZENTA | LINAGLIPTIN | 1 | Oral | 5 MG, QD | 0 | 5 | MG | TABLET | QD | ||||||
122818533 | 12281853 | 9 | C | SUREPOST | REPAGLINIDE | 1 | Oral | 1.5 MG, DAILY | 0 | 1.5 | MG | TABLET | QD | ||||||
122818533 | 12281853 | 10 | C | WARFARIN | WARFARIN | 1 | Oral | 1-2MG, QD | 0 | TABLET | QD | ||||||||
122818533 | 12281853 | 11 | C | ADALAT | NIFEDIPINE | 1 | Oral | 20-40MG, QD | 0 | TABLET | QD | ||||||||
122818533 | 12281853 | 12 | C | NU-LOTAN | LOSARTAN POTASSIUM | 1 | Oral | 50 MG, QD | 0 | 50 | MG | TABLET | QD | ||||||
122818533 | 12281853 | 13 | C | CARVEDILOL. | CARVEDILOL | 1 | Oral | 10 MG, QD | 0 | 10 | MG | TABLET | QD | ||||||
122818533 | 12281853 | 14 | C | HYDREA | HYDROXYUREA | 1 | Oral | 500-1000MG, DAILY | 0 | CAPSULE | QD | ||||||||
122818533 | 12281853 | 15 | C | TAKEPRON | LANSOPRAZOLE | 1 | Oral | 15 MG, QD | 0 | 15 | MG | TABLET | QD | ||||||
122818533 | 12281853 | 16 | C | FUROSEMIDE. | FUROSEMIDE | 1 | Oral | 20-40 MG, QD | 0 | TABLET | QD | ||||||||
122818533 | 12281853 | 17 | C | FEBURIC | FEBUXOSTAT | 1 | Oral | 10-20MG, QD | 0 | TABLET | QD | ||||||||
122818533 | 12281853 | 18 | C | PREDONINE | PREDNISOLONEPREDNISOLONE ACETATEPREDNISOLONE SODIUM SUCCINATE | 1 | Oral | 10-35 MG, QOD | 0 | TABLET | QOD | ||||||||
122818533 | 12281853 | 19 | C | MAGMITT | MAGNESIUM OXIDE | 1 | Oral | 330-990 MG, DAILY | 0 | TABLET | QD | ||||||||
122818533 | 12281853 | 20 | C | REBAMIPIDE | REBAMIPIDE | 1 | Oral | 300 MG, DAILY | 0 | 300 | MG | TABLET | QD | ||||||
122818533 | 12281853 | 21 | C | CRAVIT | LEVOFLOXACIN | 1 | Ophthalmic | 5 ML, PRN | 0 | 5 | ML | EYE DROPS | /yr | ||||||
122818533 | 12281853 | 22 | C | CRAVIT | LEVOFLOXACIN | 1 | Oral | 250 MG, QD | 0 | 250 | MG | EYE DROPS | QD | ||||||
122818533 | 12281853 | 23 | C | DICLOD | DICLOFENAC SODIUM | 1 | Ophthalmic | 5 ML, PRN | 0 | 5 | ML | EYE DROPS | /yr | ||||||
122818533 | 12281853 | 24 | C | RINDERON /00008501/ | BETAMETHASONE | 1 | Nasal | 5 ML, PRN | 0 | 5 | ML | /yr | |||||||
122818533 | 12281853 | 25 | C | LOXOPROFEN | LOXOPROFEN | 1 | Oral | UNK, PRN | 0 | TABLET | /yr | ||||||||
122818533 | 12281853 | 26 | C | FLUMETHOLON | FLUOROMETHOLONE | 1 | Ophthalmic | 10 ML, PRN | 0 | 10 | ML | EYE DROPS | /yr | ||||||
122818533 | 12281853 | 27 | C | LIXIANA | EDOXABAN TOSILATE MONOHYDRATE | 1 | Oral | 60 MG, QD | 0 | 60 | MG | TABLET | QD | ||||||
122818533 | 12281853 | 28 | C | MAGCOROL P | 2 | Unknown | UNK, PRN | 0 | /yr | ||||||||||
122818533 | 12281853 | 29 | C | INAVIR /07146202/ | 2 | 40 MG, QD | 0 | 40 | MG | QD | |||||||||
122818533 | 12281853 | 30 | C | VITAMEDIN /00274301/ | 2 | Intravenous (not otherwise specified) | UNK, QD | 0 | INJECTION | QD |
Indications of drugs used
Event ID | CASEID | INDI DRUG SEQ | INDI PT |
---|---|---|---|
122818533 | 12281853 | 1 | Paroxysmal nocturnal haemoglobinuria |
122818533 | 12281853 | 6 | Paroxysmal nocturnal haemoglobinuria |
122818533 | 12281853 | 7 | Product used for unknown indication |
122818533 | 12281853 | 8 | Product used for unknown indication |
122818533 | 12281853 | 9 | Product used for unknown indication |
122818533 | 12281853 | 10 | Paroxysmal nocturnal haemoglobinuria |
122818533 | 12281853 | 11 | Product used for unknown indication |
122818533 | 12281853 | 12 | Product used for unknown indication |
122818533 | 12281853 | 13 | Product used for unknown indication |
122818533 | 12281853 | 14 | Product used for unknown indication |
122818533 | 12281853 | 15 | Product used for unknown indication |
122818533 | 12281853 | 16 | Product used for unknown indication |
122818533 | 12281853 | 17 | Product used for unknown indication |
122818533 | 12281853 | 18 | Paroxysmal nocturnal haemoglobinuria |
122818533 | 12281853 | 19 | Product used for unknown indication |
122818533 | 12281853 | 20 | Product used for unknown indication |
122818533 | 12281853 | 21 | Product used for unknown indication |
122818533 | 12281853 | 23 | Product used for unknown indication |
122818533 | 12281853 | 24 | Product used for unknown indication |
122818533 | 12281853 | 25 | Product used for unknown indication |
122818533 | 12281853 | 26 | Product used for unknown indication |
122818533 | 12281853 | 27 | Product used for unknown indication |
122818533 | 12281853 | 28 | Product used for unknown indication |
122818533 | 12281853 | 29 | Product used for unknown indication |
122818533 | 12281853 | 30 | Product used for unknown indication |
Outcome of event
Event ID | CASEID | OUTC COD |
---|---|---|
122818533 | 12281853 | OT |
Reactions reported
Event ID | CASEID | DRUG REC ACT | PT |
---|---|---|---|
122818533 | 12281853 | Drug ineffective | |
122818533 | 12281853 | Renal impairment | |
122818533 | 12281853 | Small intestinal ulcer haemorrhage |
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 |
---|---|---|---|---|---|---|
122818533 | 12281853 | 1 | 20120626 | 20120724 | 0 | |
122818533 | 12281853 | 2 | 20120807 | 0 | ||
122818533 | 12281853 | 6 | 20131210 | 20150312 | 0 | |
122818533 | 12281853 | 8 | 20150401 | 20150511 | 0 | |
122818533 | 12281853 | 9 | 20150401 | 20160118 | 0 | |
122818533 | 12281853 | 10 | 20120412 | 20151011 | 0 | |
122818533 | 12281853 | 11 | 20120326 | 0 | ||
122818533 | 12281853 | 12 | 20120325 | 0 | ||
122818533 | 12281853 | 14 | 20121225 | 20160131 | 0 | |
122818533 | 12281853 | 15 | 20120329 | 0 | ||
122818533 | 12281853 | 17 | 20150401 | 20160331 | 0 | |
122818533 | 12281853 | 18 | 20140304 | 0 | ||
122818533 | 12281853 | 19 | 20150401 | 20160331 | 0 | |
122818533 | 12281853 | 20 | 20150706 | 20150719 | 0 | |
122818533 | 12281853 | 21 | 20150203 | 0 | ||
122818533 | 12281853 | 22 | 20150803 | 0 | ||
122818533 | 12281853 | 23 | 20150707 | 20150728 | 0 | |
122818533 | 12281853 | 24 | 20150707 | 20150707 | 0 | |
122818533 | 12281853 | 25 | 20150710 | 20160331 | 0 | |
122818533 | 12281853 | 26 | 20150710 | 20150728 | 0 | |
122818533 | 12281853 | 27 | 20151005 | 20151101 | 0 | |
122818533 | 12281853 | 28 | 20160119 | 20160119 | 0 | |
122818533 | 12281853 | 29 | 20160222 | 20160222 | 0 | |
122818533 | 12281853 | 30 | 20160315 | 20160315 | 0 |