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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116545357 | 11654535 | 7 | F | 20141104 | 20160628 | 20151023 | 20160711 | EXP | US-ALEXION-A201504050 | ALEXION | 72.30 | YR | M | Y | 0.00000 | 20160711 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116545357 | 11654535 | 1 | PS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 900 MG, Q2W | Y | T2-AD9299B01R | 125166 | 900 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | ||||
| 116545357 | 11654535 | 2 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 1200 MG, Q2W | Y | 125166 | 1200 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | |||||
| 116545357 | 11654535 | 3 | C | CYCLOSPORIN | CYCLOSPORINE | 1 | Unknown | UNK | 0 | ||||||||||
| 116545357 | 11654535 | 4 | C | CYCLOSPORIN | CYCLOSPORINE | 1 | Unknown | 75 MG, IN THE MORNING | 0 | 75 | MG | ||||||||
| 116545357 | 11654535 | 5 | C | CYCLOSPORIN | CYCLOSPORINE | 1 | Unknown | 50 MG, IN THE EVENING | 0 | 50 | MG | ||||||||
| 116545357 | 11654535 | 6 | C | FOLIC ACID. | FOLIC ACID | 1 | Unknown | UNK | 0 | ||||||||||
| 116545357 | 11654535 | 7 | C | IRON | IRON | 1 | Unknown | UNK | 0 | ||||||||||
| 116545357 | 11654535 | 8 | C | VITAMIN B12 | CYANOCOBALAMIN | 1 | Unknown | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 116545357 | 11654535 | 1 | Paroxysmal nocturnal haemoglobinuria |
| 116545357 | 11654535 | 3 | Product used for unknown indication |
| 116545357 | 11654535 | 6 | Product used for unknown indication |
| 116545357 | 11654535 | 7 | Product used for unknown indication |
| 116545357 | 11654535 | 8 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 116545357 | 11654535 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 116545357 | 11654535 | Asthenia | |
| 116545357 | 11654535 | Blood lactate dehydrogenase increased | |
| 116545357 | 11654535 | Dizziness | |
| 116545357 | 11654535 | Haematocrit decreased | |
| 116545357 | 11654535 | Haemoglobin decreased | |
| 116545357 | 11654535 | Incorrect dose administered | |
| 116545357 | 11654535 | Platelet count decreased | |
| 116545357 | 11654535 | Red blood cell count decreased | |
| 116545357 | 11654535 | White blood cell 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 |
|---|---|---|---|---|---|---|
| 116545357 | 11654535 | 1 | 20100125 | 0 | ||
| 116545357 | 11654535 | 2 | 20160305 | 0 | ||
| 116545357 | 11654535 | 3 | 20150714 | 0 | ||
| 116545357 | 11654535 | 4 | 20150908 | 0 | ||
| 116545357 | 11654535 | 5 | 20150908 | 0 | ||
| 116545357 | 11654535 | 8 | 20160416 | 0 |