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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127805301 | 12780530 | 1 | I | 20090430 | 20090623 | 20160926 | 20160926 | EXP | JP-SA-THYM-1001077 | AVENTIS | 71.00 | YR | E | F | Y | 64.00000 | KG | 20160926 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127805301 | 12780530 | 1 | PS | THYMOGLOBULINE | LAPINE T-LYMPHOCYTE IMMUNE GLOBULIN | 1 | Intravenous (not otherwise specified) | 3.5 MG/KG, QD | 10.2 | MG/KG | C8034NB | 103869 | 3.5 | MG/KG | POWDER FOR SOLUTION FOR INFUSION | QD | |||
| 127805301 | 12780530 | 2 | C | CICLOSPORIN | CYCLOSPORINE | 1 | Oral | 150 MG, BID | 900 | MG | UNKNOWN | 0 | 150 | MG | BID | ||||
| 127805301 | 12780530 | 3 | C | METHYLPREDNISOLONE SODIUM SUCCINATE. | METHYLPREDNISOLONE SODIUM SUCCINATE | 1 | 500 MG, UNK | UNKNOWN | 0 | 500 | MG | ||||||||
| 127805301 | 12780530 | 4 | C | ITRACONAZOLE. | ITRACONAZOLE | 1 | Oral | 2 DF, QD | 10 | DF | UNKNOWN | 0 | 2 | DF | QD | ||||
| 127805301 | 12780530 | 5 | C | SULFAMETHOXAZOLE | SULFAMETHOXAZOLE | 1 | Oropharingeal | 1 DF, QD | 5 | DF | UNKNOWN | 0 | 1 | DF | QD | ||||
| 127805301 | 12780530 | 6 | C | CEFEPIME | CEFEPIME HYDROCHLORIDE | 1 | UNK | 0 | |||||||||||
| 127805301 | 12780530 | 7 | C | FILGRASTIM | FILGRASTIM | 1 | UNK | 0 | |||||||||||
| 127805301 | 12780530 | 8 | C | PREDNISOLONE. | PREDNISOLONE | 1 | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127805301 | 12780530 | 1 | Aplastic anaemia |
| 127805301 | 12780530 | 2 | Aplastic anaemia |
| 127805301 | 12780530 | 3 | Premedication |
| 127805301 | 12780530 | 4 | Prophylaxis |
| 127805301 | 12780530 | 5 | Prophylaxis |
| 127805301 | 12780530 | 6 | Product used for unknown indication |
| 127805301 | 12780530 | 7 | Prophylaxis |
| 127805301 | 12780530 | 8 | Aplastic anaemia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127805301 | 12780530 | OT |
| 127805301 | 12780530 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127805301 | 12780530 | Histiocytosis haematophagic | |
| 127805301 | 12780530 | Pneumonia | |
| 127805301 | 12780530 | Therapy non-responder | |
| 127805301 | 12780530 | 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 |
|---|---|---|---|---|---|---|
| 127805301 | 12780530 | 1 | 20090427 | 20090501 | 0 | |
| 127805301 | 12780530 | 2 | 20090427 | 20090620 | 0 | |
| 127805301 | 12780530 | 3 | 20090425 | 20090426 | 0 | |
| 127805301 | 12780530 | 4 | 20090425 | 20090621 | 0 | |
| 127805301 | 12780530 | 5 | 20090425 | 20090527 | 0 | |
| 127805301 | 12780530 | 6 | 20090423 | 20090506 | 0 | |
| 127805301 | 12780530 | 7 | 20090423 | 20090621 | 0 | |
| 127805301 | 12780530 | 8 | 20090427 | 20090620 | 0 |