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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123397833 | 12339783 | 3 | F | 201604 | 20160916 | 20160506 | 20160923 | EXP | CA-ALEXION PHARMACEUTICALS INC-A201603199 | ALEXION | 76.52 | YR | M | Y | 77.00000 | KG | 20160923 | OT | CA | CA |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123397833 | 12339783 | 1 | PS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 600 MG, QW | AB7976C | 125166 | 600 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | /wk | |||||
| 123397833 | 12339783 | 2 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 900 MG, Q2W | AB7976C | 125166 | 900 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | |||||
| 123397833 | 12339783 | 3 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 900 MG, Q2W | AD9299B04 | 125166 | 900 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | |||||
| 123397833 | 12339783 | 4 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 900 MG, Q2W | AE7317B04 | 125166 | 900 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | |||||
| 123397833 | 12339783 | 5 | C | RAMIPRIL. | RAMIPRIL | 1 | Oral | 5 MG, QD | 0 | 5 | MG | QD | |||||||
| 123397833 | 12339783 | 6 | C | ATORVASTATIN | ATORVASTATIN | 1 | Oral | 20 MG, QD | 0 | 20 | MG | QD | |||||||
| 123397833 | 12339783 | 7 | C | TYLENOL | ACETAMINOPHEN | 1 | Oral | NIGHT TIME 1 TAB, HS, PRN | 0 | /yr | |||||||||
| 123397833 | 12339783 | 8 | C | PENICILLIN /00000901/ | PENICILLIN G | 1 | Oral | 300 MG, BID | 0 | 300 | MG | BID | |||||||
| 123397833 | 12339783 | 9 | C | ORACORT /00031902/ | 2 | Oral | UNK UNK, BID | 0 | BID | ||||||||||
| 123397833 | 12339783 | 10 | C | EPREX | ERYTHROPOIETIN | 1 | Unknown | UNK, TIW | 0 | TIW | |||||||||
| 123397833 | 12339783 | 11 | C | ASA | ASPIRIN | 1 | Oral | 81 MG, QD | 0 | 81 | MG | QD | |||||||
| 123397833 | 12339783 | 12 | C | ACETAMINOPHEN. | ACETAMINOPHEN | 1 | Oral | UNK, PRN | 0 | /yr | |||||||||
| 123397833 | 12339783 | 13 | C | METOPROLOL. | METOPROLOL | 1 | Oral | 50 MG, BID | 0 | 50 | MG | BID | |||||||
| 123397833 | 12339783 | 14 | C | NITROGLYCERIN. | NITROGLYCERIN | 1 | Unknown | UNK, QD (12 TO 14HRS PER DAY) | 0 | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123397833 | 12339783 | 1 | Paroxysmal nocturnal haemoglobinuria |
| 123397833 | 12339783 | 5 | Product used for unknown indication |
| 123397833 | 12339783 | 6 | Product used for unknown indication |
| 123397833 | 12339783 | 7 | Product used for unknown indication |
| 123397833 | 12339783 | 8 | Prophylaxis |
| 123397833 | 12339783 | 9 | Product used for unknown indication |
| 123397833 | 12339783 | 10 | Product used for unknown indication |
| 123397833 | 12339783 | 11 | Product used for unknown indication |
| 123397833 | 12339783 | 12 | Product used for unknown indication |
| 123397833 | 12339783 | 13 | Product used for unknown indication |
| 123397833 | 12339783 | 14 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123397833 | 12339783 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123397833 | 12339783 | Anaemia | |
| 123397833 | 12339783 | Blood lactate dehydrogenase increased | |
| 123397833 | 12339783 | Fatigue | |
| 123397833 | 12339783 | Haemoglobin decreased | |
| 123397833 | 12339783 | Myocardial infarction |
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 |
|---|---|---|---|---|---|---|
| 123397833 | 12339783 | 1 | 20141007 | 20141027 | 0 | |
| 123397833 | 12339783 | 2 | 20141103 | 0 | ||
| 123397833 | 12339783 | 3 | 20141103 | 0 | ||
| 123397833 | 12339783 | 4 | 20141103 | 0 | ||
| 123397833 | 12339783 | 8 | 20141027 | 0 |