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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 84029296 | 8402929 | 6 | F | 20120110 | 20160902 | 20120213 | 20160909 | EXP | JP-ALEXION-A201200217 | ALEXION | 70.00 | YR | M | Y | 0.00000 | 20160909 | MD | JP | JP |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 84029296 | 8402929 | 1 | PS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 600 MG, QW | 1200 | MG | 125166 | 600 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | /wk | ||||
| 84029296 | 8402929 | 2 | SS | NEORAL | CYCLOSPORINE | 1 | Oral | 100-75 MG, DAILY | 0 | ||||||||||
| 84029296 | 8402929 | 3 | SS | NEORAL | CYCLOSPORINE | 1 | Oral | 75-50 MG, DAILY | 0 | ||||||||||
| 84029296 | 8402929 | 4 | SS | PREDNISOLONE. | PREDNISOLONE | 1 | Oral | 20 MG, DAILY | 235 | MG | 0 | 20 | MG | QD | |||||
| 84029296 | 8402929 | 5 | SS | PREDNISOLONE. | PREDNISOLONE | 1 | Oral | 15 MG, DAILY | 235 | MG | 0 | 15 | MG | QD | |||||
| 84029296 | 8402929 | 6 | SS | PREDNISOLONE. | PREDNISOLONE | 1 | Oral | 10 MG, DAILY | 235 | MG | 0 | 10 | MG | QD | |||||
| 84029296 | 8402929 | 7 | SS | PREDNISOLONE. | PREDNISOLONE | 1 | Oral | 5 MG, DAILY | 235 | MG | 0 | 5 | MG | QD | |||||
| 84029296 | 8402929 | 8 | C | CORTRIL | HYDROCORTISONE | 1 | Unknown | 0 | |||||||||||
| 84029296 | 8402929 | 9 | C | Prodif | FOSFLUCONAZOLE | 1 | Unknown | 100 MG, QD | 0 | 100 | MG | QD | |||||||
| 84029296 | 8402929 | 10 | C | ITRACONAZOLE. | ITRACONAZOLE | 1 | Unknown | 200 MG, QD | 0 | 200 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 84029296 | 8402929 | 1 | Paroxysmal nocturnal haemoglobinuria |
| 84029296 | 8402929 | 2 | Product used for unknown indication |
| 84029296 | 8402929 | 4 | Product used for unknown indication |
| 84029296 | 8402929 | 8 | Product used for unknown indication |
| 84029296 | 8402929 | 9 | Candida endophthalmitis |
| 84029296 | 8402929 | 10 | Candida endophthalmitis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 84029296 | 8402929 | OT |
| 84029296 | 8402929 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 84029296 | 8402929 | Blood lactate dehydrogenase increased | |
| 84029296 | 8402929 | Haemoglobin decreased | |
| 84029296 | 8402929 | Platelet count decreased | |
| 84029296 | 8402929 | Pneumocystis jirovecii pneumonia | |
| 84029296 | 8402929 | Pneumonia bacterial | |
| 84029296 | 8402929 | Pneumonia fungal | |
| 84029296 | 8402929 | Pneumonia viral |
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 |
|---|---|---|---|---|---|---|
| 84029296 | 8402929 | 1 | 20120110 | 20120117 | 0 | |
| 84029296 | 8402929 | 2 | 201007 | 0 | ||
| 84029296 | 8402929 | 3 | 201007 | 20120207 | 0 | |
| 84029296 | 8402929 | 4 | 201007 | 20111225 | 0 | |
| 84029296 | 8402929 | 5 | 20111226 | 20120103 | 0 | |
| 84029296 | 8402929 | 6 | 20120104 | 20120109 | 0 | |
| 84029296 | 8402929 | 7 | 20120110 | 20120117 | 0 | |
| 84029296 | 8402929 | 9 | 20111124 | 20120124 | 0 | |
| 84029296 | 8402929 | 10 | 20111227 | 20120124 | 0 |