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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127998311 | 12799831 | 1 | I | 20150523 | 20150529 | 20160930 | 20160930 | EXP | IT-ALEXION PHARMACEUTICALS INC.-A201502058 | ALEXION | 33.28 | YR | F | Y | 0.00000 | 20160930 | OT | IT | IT |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127998311 | 12799831 | 1 | PS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 900 MG, UNK | Y | 125166 | 900 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | ||||||
| 127998311 | 12799831 | 2 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 1200 MG, Q2W | Y | 125166 | 1200 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | |||||
| 127998311 | 12799831 | 3 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 1200 MG, Q3W | Y | 125166 | 1200 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | Q3W | |||||
| 127998311 | 12799831 | 4 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 1200 MG, QMONTH/ EVERY 28 DAYS | Y | 125166 | 1200 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | /month | |||||
| 127998311 | 12799831 | 5 | C | LABETALOL | LABETALOLLABETALOL HYDROCHLORIDE | 1 | Unknown | 0 | |||||||||||
| 127998311 | 12799831 | 6 | C | METHYLDOPA. | METHYLDOPA | 1 | Unknown | 0 | |||||||||||
| 127998311 | 12799831 | 7 | C | NIFEDIPINE. | NIFEDIPINE | 1 | Unknown | 0 | |||||||||||
| 127998311 | 12799831 | 8 | C | ALBUMIN | ALBUMIN HUMAN | 1 | Unknown | UNK, INFUSION | 0 | ||||||||||
| 127998311 | 12799831 | 9 | C | MAGNESIUM SULFATE. | MAGNESIUM SULFATE | 1 | Unknown | UNK, INFUSION | 0 | ||||||||||
| 127998311 | 12799831 | 10 | C | CEFTRIAXONE. | CEFTRIAXONE | 1 | Unknown | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127998311 | 12799831 | 1 | Haemolytic uraemic syndrome |
| 127998311 | 12799831 | 5 | Hypertension |
| 127998311 | 12799831 | 6 | Hypertension |
| 127998311 | 12799831 | 7 | Hypertension |
| 127998311 | 12799831 | 8 | Generalised tonic-clonic seizure |
| 127998311 | 12799831 | 9 | Generalised tonic-clonic seizure |
| 127998311 | 12799831 | 10 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127998311 | 12799831 | HO |
| 127998311 | 12799831 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127998311 | 12799831 | Cholecystitis acute | |
| 127998311 | 12799831 | Haptoglobin decreased | |
| 127998311 | 12799831 | Inappropriate schedule of drug administration | |
| 127998311 | 12799831 | Incorrect dose administered | |
| 127998311 | 12799831 | 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 |
|---|---|---|---|---|---|---|
| 127998311 | 12799831 | 1 | 20150415 | 0 |