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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 98317194 | 9831719 | 4 | F | 20160621 | 20140121 | 20160701 | EXP | US-ALEXION PHARMACEUTICALS INC.-A201400057 | ALEXION | 10.00 | YR | M | Y | 52.00000 | KG | 20160701 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 98317194 | 9831719 | 1 | PS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 900 MG, QW | 125166 | 900 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | /wk | ||||||
| 98317194 | 9831719 | 2 | SS | SOLIRIS | ECULIZUMAB | 1 | 125166 | CONCENTRATE FOR SOLUTION FOR INFUSION | |||||||||||
| 98317194 | 9831719 | 3 | C | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Unknown | 2 MG/KG, QD | 0 | 2 | MG/KG | QD | |||||||
| 98317194 | 9831719 | 4 | C | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | 0 | ||||||||||||
| 98317194 | 9831719 | 5 | C | INFLIXIMAB | INFLIXIMAB | 1 | Unknown | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 98317194 | 9831719 | 1 | Thrombotic microangiopathy |
| 98317194 | 9831719 | 2 | Off label use |
| 98317194 | 9831719 | 3 | Graft versus host disease |
| 98317194 | 9831719 | 4 | Intestinal haemorrhage |
| 98317194 | 9831719 | 5 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 98317194 | 9831719 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 98317194 | 9831719 | Drug ineffective | |
| 98317194 | 9831719 | Drug level below therapeutic | |
| 98317194 | 9831719 | Inappropriate schedule of drug administration | |
| 98317194 | 9831719 | Incorrect dose administered | |
| 98317194 | 9831719 | Off label use | |
| 98317194 | 9831719 | Organ failure |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |