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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125377814 | 12537781 | 4 | F | 201602 | 20160906 | 20160707 | 20160912 | EXP | GB-ALEXION PHARMACEUTICALS INC.-A201601395 | ALEXION | 51.30 | YR | M | Y | 0.00000 | 20160912 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125377814 | 12537781 | 1 | PS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | UNK | 125166 | CONCENTRATE FOR SOLUTION FOR INFUSION | |||||||||
| 125377814 | 12537781 | 2 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 1200 MG, Q2W | P0004002 | 125166 | 1200 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | |||||
| 125377814 | 12537781 | 3 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 1200 MG, Q2W | P0004102 | 125166 | 1200 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | |||||
| 125377814 | 12537781 | 4 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 1200 MG, Q2W | P0004202 | 125166 | 1200 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | |||||
| 125377814 | 12537781 | 5 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 1200 MG, Q2W | P0004302 | 125166 | 1200 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | |||||
| 125377814 | 12537781 | 6 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 1200 MG, Q2W | P0004708 | 125166 | 1200 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | |||||
| 125377814 | 12537781 | 7 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 1200 MG, Q2W | P0004801 | 125166 | 1200 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | |||||
| 125377814 | 12537781 | 8 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 1200 MG, UNK | P0005002R | 125166 | 1200 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | ||||||
| 125377814 | 12537781 | 9 | SS | CITALOPRAM | CITALOPRAM HYDROBROMIDE | 1 | Oral | 40 MG, UNK | N | 0 | 40 | MG | |||||||
| 125377814 | 12537781 | 10 | SS | CITALOPRAM | CITALOPRAM HYDROBROMIDE | 1 | Oral | UNK | N | 0 | |||||||||
| 125377814 | 12537781 | 11 | C | KEPPRA | LEVETIRACETAM | 1 | Oral | UNK, QD | 0 | QD | |||||||||
| 125377814 | 12537781 | 12 | C | KEPPRA | LEVETIRACETAM | 1 | Oral | 250 ML, QD | 0 | 250 | ML | QD | |||||||
| 125377814 | 12537781 | 13 | C | PENICILLIN /00000901/ | PENICILLIN G | 1 | Oral | UNK | 0 | ||||||||||
| 125377814 | 12537781 | 14 | C | BISOPROLOL | BISOPROLOL | 1 | Unknown | UNK | 0 | ||||||||||
| 125377814 | 12537781 | 15 | C | PREGABALIN. | PREGABALIN | 1 | Unknown | UNK | 0 | ||||||||||
| 125377814 | 12537781 | 16 | C | PREGABALIN. | PREGABALIN | 1 | Unknown | 200 MG, TID | 0 | 200 | MG | TID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125377814 | 12537781 | 1 | Paroxysmal nocturnal haemoglobinuria |
| 125377814 | 12537781 | 9 | Product used for unknown indication |
| 125377814 | 12537781 | 11 | Product used for unknown indication |
| 125377814 | 12537781 | 13 | Prophylaxis |
| 125377814 | 12537781 | 14 | Product used for unknown indication |
| 125377814 | 12537781 | 15 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125377814 | 12537781 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125377814 | 12537781 | Abdominal pain | |
| 125377814 | 12537781 | Drug withdrawal headache | |
| 125377814 | 12537781 | Splenomegaly | |
| 125377814 | 12537781 | Vomiting |
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 |
|---|---|---|---|---|---|---|
| 125377814 | 12537781 | 2 | 20131210 | 0 | ||
| 125377814 | 12537781 | 8 | 20131210 | 0 | ||
| 125377814 | 12537781 | 9 | 201602 | 0 | ||
| 125377814 | 12537781 | 10 | 201602 | 0 | ||
| 125377814 | 12537781 | 12 | 201602 | 0 |