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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118588483 | 11858848 | 3 | F | 20120612 | 20160808 | 20151222 | 20160818 | EXP | JP-ALXN-A201505116AA | ALEXION | 82.00 | YR | F | Y | 45.00000 | KG | 20160818 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118588483 | 11858848 | 1 | PS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 600 MG, QW | 2400 | MG | N | U | 125166 | 600 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | /wk | ||
| 118588483 | 11858848 | 2 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 900 MG, Q2W | 2400 | MG | N | U | 125166 | 900 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | ||
| 118588483 | 11858848 | 3 | C | PREDONINE | PREDNISOLONEPREDNISOLONE ACETATEPREDNISOLONE SODIUM SUCCINATE | 1 | Unknown | 10 MG, QD | 0 | 10 | MG | QD | |||||||
| 118588483 | 11858848 | 4 | C | PREDONINE | PREDNISOLONEPREDNISOLONE ACETATEPREDNISOLONE SODIUM SUCCINATE | 1 | Unknown | 40 MG, QD | 0 | 40 | MG | QD | |||||||
| 118588483 | 11858848 | 5 | C | PREDONINE | PREDNISOLONEPREDNISOLONE ACETATEPREDNISOLONE SODIUM SUCCINATE | 1 | Unknown | 2.5-40 MG, DAILY | 0 | QD | |||||||||
| 118588483 | 11858848 | 6 | C | PROMAC /00024401/ | NITROFURANTOIN | 1 | Oral | 1 DF, BID | 0 | TABLET | BID | ||||||||
| 118588483 | 11858848 | 7 | C | THYRADIN S | LEVOTHYROXINE SODIUM | 1 | Oral | 100 ?G, DAILY | 0 | 100 | UG | TABLET | QD | ||||||
| 118588483 | 11858848 | 8 | C | LANIRAPID | METILDIGOXIN | 1 | Oral | 1 DF, DAILY | 0 | TABLET | QD | ||||||||
| 118588483 | 11858848 | 9 | C | MEVARICH | PRAVASTATIN | 1 | Oral | 1 DF, QD | 0 | TABLET | QD | ||||||||
| 118588483 | 11858848 | 10 | C | GLACTIV | SITAGLIPTIN | 1 | Oral | 1 DF, QD | 0 | TABLET | QD | ||||||||
| 118588483 | 11858848 | 11 | C | POSTERISAN /00521801/ | 2 | Transdermal | UNK | 0 | |||||||||||
| 118588483 | 11858848 | 12 | C | CALONAL | ACETAMINOPHEN | 1 | Unknown | UNK, QD | 0 | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 118588483 | 11858848 | 1 | Paroxysmal nocturnal haemoglobinuria |
| 118588483 | 11858848 | 3 | Immune thrombocytopenic purpura |
| 118588483 | 11858848 | 6 | Product used for unknown indication |
| 118588483 | 11858848 | 7 | Product used for unknown indication |
| 118588483 | 11858848 | 8 | Product used for unknown indication |
| 118588483 | 11858848 | 9 | Product used for unknown indication |
| 118588483 | 11858848 | 10 | Product used for unknown indication |
| 118588483 | 11858848 | 11 | Product used for unknown indication |
| 118588483 | 11858848 | 12 | Spinal compression fracture |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 118588483 | 11858848 | OT |
| 118588483 | 11858848 | DE |
| 118588483 | 11858848 | LT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 118588483 | 11858848 | Drug ineffective | |
| 118588483 | 11858848 | Escherichia pyelonephritis | |
| 118588483 | 11858848 | Escherichia sepsis | |
| 118588483 | 11858848 | Neutropenia | |
| 118588483 | 11858848 | Pneumonia |
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 |
|---|---|---|---|---|---|---|
| 118588483 | 11858848 | 1 | 20120521 | 20120611 | 0 | |
| 118588483 | 11858848 | 2 | 20120618 | 20120702 | 0 | |
| 118588483 | 11858848 | 3 | 2003 | 0 | ||
| 118588483 | 11858848 | 4 | 2012 | 0 | ||
| 118588483 | 11858848 | 5 | 20120615 | 0 | ||
| 118588483 | 11858848 | 12 | 20120529 | 20120810 | 0 |