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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1133705410 | 11337054 | 10 | F | 20150618 | 20160809 | 20150804 | 20160816 | EXP | IE-ALEXION PHARMACEUTICALS INC-A201502474 | ALEXION | 53.29 | YR | F | Y | 0.00000 | 20160816 | PH | IE | IE |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1133705410 | 11337054 | 1 | PS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 900 MG, Q2W | P0002902 | 125166 | 900 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | |||||
| 1133705410 | 11337054 | 2 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 900 MG, Q2W | POOO3202 | 125166 | 900 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | |||||
| 1133705410 | 11337054 | 3 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 900 MG, Q2W | P0003302 | 125166 | 900 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | |||||
| 1133705410 | 11337054 | 4 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 900 MG, Q2W | P0004707 | 125166 | 900 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | |||||
| 1133705410 | 11337054 | 5 | C | DIPROSALIC | BETAMETHASONE DIPROPIONATE | 1 | Topical | 0 | CREAM | ||||||||||
| 1133705410 | 11337054 | 6 | C | VALTREX | VALACYCLOVIR HYDROCHLORIDE | 1 | Unknown | 0 | |||||||||||
| 1133705410 | 11337054 | 7 | C | DUODERM /00504601/ | 2 | Unknown | 0 | ||||||||||||
| 1133705410 | 11337054 | 8 | C | NEXIUM | ESOMEPRAZOLE MAGNESIUM | 1 | Unknown | 0 | |||||||||||
| 1133705410 | 11337054 | 9 | C | GAVISCON /00237601/ | ALUMINUM HYDROXIDEMAGNESIUM CARBONATE | 1 | Unknown | 0 | |||||||||||
| 1133705410 | 11337054 | 10 | C | ZOTON | LANSOPRAZOLE | 1 | Unknown | 30 MG, QD | 0 | 30 | MG | QD | |||||||
| 1133705410 | 11337054 | 11 | C | CALVEPEN | 2 | Other | 666 MG, BID | 0 | 666 | MG | BID | ||||||||
| 1133705410 | 11337054 | 12 | C | FOLIC ACID. | FOLIC ACID | 1 | Other | 5 MG, QD | 0 | 5 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 1133705410 | 11337054 | 1 | Paroxysmal nocturnal haemoglobinuria |
| 1133705410 | 11337054 | 5 | Product used for unknown indication |
| 1133705410 | 11337054 | 6 | Product used for unknown indication |
| 1133705410 | 11337054 | 7 | Product used for unknown indication |
| 1133705410 | 11337054 | 8 | Product used for unknown indication |
| 1133705410 | 11337054 | 9 | Product used for unknown indication |
| 1133705410 | 11337054 | 10 | Product used for unknown indication |
| 1133705410 | 11337054 | 11 | Product used for unknown indication |
| 1133705410 | 11337054 | 12 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 1133705410 | 11337054 | OT |
| 1133705410 | 11337054 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 1133705410 | 11337054 | Drug ineffective | |
| 1133705410 | 11337054 | Haemoglobin decreased | |
| 1133705410 | 11337054 | Low density lipoprotein abnormal | |
| 1133705410 | 11337054 | Myelodysplastic syndrome | |
| 1133705410 | 11337054 | Neutrophil count decreased | |
| 1133705410 | 11337054 | Platelet count decreased |
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 |
|---|---|---|---|---|---|---|
| 1133705410 | 11337054 | 1 | 20111125 | 0 | ||
| 1133705410 | 11337054 | 2 | 20111125 | 0 | ||
| 1133705410 | 11337054 | 3 | 20111125 | 0 | ||
| 1133705410 | 11337054 | 4 | 20111125 | 0 |