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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123984483 | 12398448 | 3 | F | 20160503 | 20160901 | 20160524 | 20160909 | EXP | GB-ALEXION PHARMACEUTICALS INC-A201603342 | ALEXION | 84.83 | YR | F | Y | 0.00000 | 20160909 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123984483 | 12398448 | 1 | PS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 600 MG, QW | 125166 | 600 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | /wk | ||||||
| 123984483 | 12398448 | 2 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 900 MG, Q2W | P0004302 | 125166 | 900 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | |||||
| 123984483 | 12398448 | 3 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 900 MG, Q2W | P0004707 | 125166 | 900 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | |||||
| 123984483 | 12398448 | 4 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 900 MG, Q2W | P0004707 | 125166 | 900 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | |||||
| 123984483 | 12398448 | 5 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 900 MG, Q2W | P0005002 | 125166 | 900 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | |||||
| 123984483 | 12398448 | 6 | C | PHENOXYMETHYLPENICILLIN | PENICILLIN V | 1 | Oral | 250 MG, BID | 0 | 250 | MG | BID | |||||||
| 123984483 | 12398448 | 7 | C | NITROFURANTOIN. | NITROFURANTOIN | 1 | Oral | 50 MG, BID | 0 | 50 | MG | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123984483 | 12398448 | 1 | Paroxysmal nocturnal haemoglobinuria |
| 123984483 | 12398448 | 6 | Product used for unknown indication |
| 123984483 | 12398448 | 7 | Infection prophylaxis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123984483 | 12398448 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123984483 | 12398448 | Anaemia | |
| 123984483 | 12398448 | Dyspnoea exertional | |
| 123984483 | 12398448 | Fatigue | |
| 123984483 | 12398448 | Haemoglobin 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 |
|---|---|---|---|---|---|---|
| 123984483 | 12398448 | 1 | 20141113 | 20141211 | 0 | |
| 123984483 | 12398448 | 2 | 20141211 | 0 | ||
| 123984483 | 12398448 | 3 | 20141211 | 0 | ||
| 123984483 | 12398448 | 4 | 20141211 | 0 | ||
| 123984483 | 12398448 | 5 | 20141211 | 0 |