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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 98538914 | 9853891 | 4 | F | 20140109 | 20160628 | 20140129 | 20160707 | EXP | US-ALEXION PHARMACEUTICALS INC.-A201400213 | ALEXION | 35.39 | YR | F | Y | 0.00000 | 20160707 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 98538914 | 9853891 | 1 | PS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | UNK | T2-AB4066D | 125166 | CONCENTRATE FOR SOLUTION FOR INFUSION | ||||||||
| 98538914 | 9853891 | 2 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | UNK | T2-AB7974C | 125166 | CONCENTRATE FOR SOLUTION FOR INFUSION | ||||||||
| 98538914 | 9853891 | 3 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 900 MG, Q2W | T2-AC1963B01 | 125166 | 900 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | |||||
| 98538914 | 9853891 | 4 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 1200 MG, Q2W | 125166 | 1200 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | ||||||
| 98538914 | 9853891 | 5 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 900 MG, Q2W | 125166 | 900 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | ||||||
| 98538914 | 9853891 | 6 | C | SYNTHROID | LEVOTHYROXINE SODIUM | 1 | Unknown | 112 ?G, QD | 0 | 112 | UG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 98538914 | 9853891 | 1 | Paroxysmal nocturnal haemoglobinuria |
| 98538914 | 9853891 | 6 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 98538914 | 9853891 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 98538914 | 9853891 | Blood lactate dehydrogenase increased | |
| 98538914 | 9853891 | Conjunctival haemorrhage | |
| 98538914 | 9853891 | Incorrect dose administered | |
| 98538914 | 9853891 | 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 |
|---|---|---|---|---|---|---|
| 98538914 | 9853891 | 1 | 20110519 | 0 | ||
| 98538914 | 9853891 | 2 | 20110519 | 0 | ||
| 98538914 | 9853891 | 4 | 20131212 | 0 | ||
| 98538914 | 9853891 | 5 | 20160623 | 0 | ||
| 98538914 | 9853891 | 6 | 20110420 | 0 |