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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1006054110 | 10060541 | 10 | F | 20140330 | 20160708 | 20140404 | 20160715 | EXP | US-ALEXION PHARMACEUTICALS INC.-A201401051 | ALEXION | 68.65 | YR | F | Y | 0.00000 | 20160715 | CN | US | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1006054110 | 10060541 | 1 | PS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | UNK | U | 125166 | CONCENTRATE FOR SOLUTION FOR INFUSION | ||||||||
| 1006054110 | 10060541 | 2 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 900 MG, QW | U | T2-AB5117C | 125166 | 900 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | /wk | ||||
| 1006054110 | 10060541 | 3 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 900 MG, Q2W | U | 125166 | 900 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | |||||
| 1006054110 | 10060541 | 4 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 1200 MG, Q2W | U | 125166 | 1200 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | |||||
| 1006054110 | 10060541 | 5 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 1200 MG, EVERY 28 DAYS | U | 125166 | 1200 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | ||||||
| 1006054110 | 10060541 | 6 | C | HYDRALAZINE | HYDRALAZINE HYDROCHLORIDE | 1 | Unknown | 5 MG, Q4 HRS PRN | 0 | 5 | MG | /yr | |||||||
| 1006054110 | 10060541 | 7 | C | LOVENOX | ENOXAPARIN SODIUM | 1 | Unknown | UNK | 0 | ||||||||||
| 1006054110 | 10060541 | 8 | C | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Unknown | 60 MG, BID | 0 | 60 | MG | BID | |||||||
| 1006054110 | 10060541 | 9 | C | NORCO | ACETAMINOPHENHYDROCODONE BITARTRATE | 1 | Unknown | 5/325, Q6 HRS PRN | 0 | /yr | |||||||||
| 1006054110 | 10060541 | 10 | C | DIGOXIN. | DIGOXIN | 1 | Unknown | 0 | |||||||||||
| 1006054110 | 10060541 | 11 | C | GEMFIBROZIL. | GEMFIBROZIL | 1 | Unknown | 600 MG, UNK | 0 | 600 | MG | ||||||||
| 1006054110 | 10060541 | 12 | C | LEVOTHYROXINE. | LEVOTHYROXINE | 1 | Unknown | 0.088, QD | 0 | QD | |||||||||
| 1006054110 | 10060541 | 13 | C | METOPROLOL. | METOPROLOL | 1 | Unknown | 5 MG, BID | 0 | 5 | MG | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 1006054110 | 10060541 | 1 | Haemolytic uraemic syndrome |
| 1006054110 | 10060541 | 6 | Hypertension |
| 1006054110 | 10060541 | 7 | Anticoagulant therapy |
| 1006054110 | 10060541 | 8 | Steroid therapy |
| 1006054110 | 10060541 | 9 | Pain |
| 1006054110 | 10060541 | 10 | Product used for unknown indication |
| 1006054110 | 10060541 | 11 | Product used for unknown indication |
| 1006054110 | 10060541 | 12 | Product used for unknown indication |
| 1006054110 | 10060541 | 13 | Hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 1006054110 | 10060541 | OT |
| 1006054110 | 10060541 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 1006054110 | 10060541 | Arthralgia | |
| 1006054110 | 10060541 | Arthritis | |
| 1006054110 | 10060541 | Blood glucose increased | |
| 1006054110 | 10060541 | Cardiac valve disease | |
| 1006054110 | 10060541 | Cough | |
| 1006054110 | 10060541 | Diabetes mellitus | |
| 1006054110 | 10060541 | Gangrene | |
| 1006054110 | 10060541 | Glycosylated haemoglobin increased | |
| 1006054110 | 10060541 | Haemolysis | |
| 1006054110 | 10060541 | Inappropriate schedule of drug administration | |
| 1006054110 | 10060541 | Necrosis | |
| 1006054110 | 10060541 | 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 |
|---|---|---|---|---|---|---|
| 1006054110 | 10060541 | 1 | 201304 | 0 | ||
| 1006054110 | 10060541 | 2 | 20140304 | 0 | ||
| 1006054110 | 10060541 | 4 | 20140304 | 0 | ||
| 1006054110 | 10060541 | 6 | 20140219 | 0 | ||
| 1006054110 | 10060541 | 7 | 20140219 | 0 | ||
| 1006054110 | 10060541 | 8 | 20140219 | 0 | ||
| 1006054110 | 10060541 | 9 | 20140219 | 0 |