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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126480752 | 12648075 | 2 | F | 20160728 | 20160824 | 20160812 | 20160831 | EXP | FR-SA-2016SA140634 | AVENTIS | 13.00 | MON | I | M | Y | 8.10000 | KG | 20160831 | MD | FR | FR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126480752 | 12648075 | 1 | PS | CAMPATH | ALEMTUZUMAB | 1 | Intravenous (not otherwise specified) | 2 DOSES WEEKLY | F3011H11 | 103948 | 7.5 | MG | /wk | ||||||
| 126480752 | 12648075 | 2 | SS | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Unknown | U | UNKNOWN | 0 | |||||||||
| 126480752 | 12648075 | 3 | SS | CYCLOSPORIN | CYCLOSPORINE | 1 | Unknown | U | UNKNOWN | 0 | |||||||||
| 126480752 | 12648075 | 4 | C | SOLUPRED | PREDNISOLONE | 1 | Oral | 0 | 2 | G | |||||||||
| 126480752 | 12648075 | 5 | C | ZOVIRAX | ACYCLOVIR | 1 | Oral | 0 | 400 | MG | |||||||||
| 126480752 | 12648075 | 6 | C | CELLCEPT | MYCOPHENOLATE MOFETILMYCOPHENOLATE MOFETIL HYDROCHLORIDE | 1 | Oral | 0 | 500 | MG | |||||||||
| 126480752 | 12648075 | 7 | C | CICLOSPORIN | CYCLOSPORINE | 1 | Oral | 0 | 50 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126480752 | 12648075 | 1 | Lymphohistiocytosis |
| 126480752 | 12648075 | 2 | Lymphohistiocytosis |
| 126480752 | 12648075 | 3 | Lymphohistiocytosis |
| 126480752 | 12648075 | 4 | Steroid therapy |
| 126480752 | 12648075 | 5 | Antiviral treatment |
| 126480752 | 12648075 | 6 | Prophylaxis against graft versus host disease |
| 126480752 | 12648075 | 7 | Prophylaxis against graft versus host disease |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126480752 | 12648075 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126480752 | 12648075 | Pyrexia | |
| 126480752 | 12648075 | Seizure | |
| 126480752 | 12648075 | Sepsis | |
| 126480752 | 12648075 | Staphylococcal infection |
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 |
|---|---|---|---|---|---|---|
| 126480752 | 12648075 | 1 | 20160224 | 20160225 | 0 | |
| 126480752 | 12648075 | 4 | 20160531 | 0 | ||
| 126480752 | 12648075 | 5 | 20150813 | 0 | ||
| 126480752 | 12648075 | 6 | 20160430 | 0 | ||
| 126480752 | 12648075 | 7 | 20160430 | 0 |