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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127804001 | 12780400 | 1 | I | 20090429 | 20090623 | 20160926 | 20160926 | EXP | JP-SA-THYM-1001078 | AVENTIS | 65.00 | YR | A | F | Y | 45.00000 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127804001 | 12780400 | 1 | PS | THYMOGLOBULINE | LAPINE T-LYMPHOCYTE IMMUNE GLOBULIN | 1 | Intravenous (not otherwise specified) | 125 MG, QD | U | C8034NB | 103869 | 125 | MG | POWDER FOR SOLUTION FOR INFUSION | QD | ||||
| 127804001 | 12780400 | 2 | C | BACTRIM | SULFAMETHOXAZOLETRIMETHOPRIM | 1 | Oral | 1 DF, QD | U | 0 | 1 | DF | QD | ||||||
| 127804001 | 12780400 | 3 | C | ITRACONAZOLE. | ITRACONAZOLE | 1 | Oral | 2 DF, QD | U | 0 | 2 | DF | QD | ||||||
| 127804001 | 12780400 | 4 | C | PREDNISOLONE. | PREDNISOLONE | 1 | UNK | N | 0 | ||||||||||
| 127804001 | 12780400 | 5 | C | CICLOSPORIN | CYCLOSPORINE | 1 | Oral | 60 MG, BID | U | 0 | 60 | MG | BID | ||||||
| 127804001 | 12780400 | 6 | C | LASIX | FUROSEMIDE | 1 | 0 | ||||||||||||
| 127804001 | 12780400 | 7 | C | DIOVAN | VALSARTAN | 1 | 0 | ||||||||||||
| 127804001 | 12780400 | 8 | C | DIOVAN | VALSARTAN | 1 | 0 | ||||||||||||
| 127804001 | 12780400 | 9 | C | FLUITRAN | TRICHLORMETHIAZIDE | 1 | 0 | ||||||||||||
| 127804001 | 12780400 | 10 | C | METHYLPREDNISOLONE SODIUM SUCCINATE. | METHYLPREDNISOLONE SODIUM SUCCINATE | 1 | 500 MG, UNK | U | 0 | 500 | MG | ||||||||
| 127804001 | 12780400 | 11 | C | AMLODIPINE BESILATE | AMLODIPINE BESYLATE | 1 | UNK | 0 | |||||||||||
| 127804001 | 12780400 | 12 | C | NORVASC | AMLODIPINE BESYLATE | 1 | 0 | ||||||||||||
| 127804001 | 12780400 | 13 | C | NORVASC | AMLODIPINE BESYLATE | 1 | 0 | ||||||||||||
| 127804001 | 12780400 | 14 | C | VALSARTAN. | VALSARTAN | 1 | UNK | 0 | |||||||||||
| 127804001 | 12780400 | 15 | C | TRICHLORMETHIAZIDE | TRICHLORMETHIAZIDE | 1 | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127804001 | 12780400 | 1 | Aplastic anaemia |
| 127804001 | 12780400 | 2 | Prophylaxis |
| 127804001 | 12780400 | 3 | Prophylaxis |
| 127804001 | 12780400 | 4 | Premedication |
| 127804001 | 12780400 | 5 | Aplastic anaemia |
| 127804001 | 12780400 | 7 | Hypertension |
| 127804001 | 12780400 | 8 | Renal failure |
| 127804001 | 12780400 | 10 | Premedication |
| 127804001 | 12780400 | 11 | Hypertension |
| 127804001 | 12780400 | 12 | Hypertension |
| 127804001 | 12780400 | 13 | Renal failure |
| 127804001 | 12780400 | 14 | Hypertension |
| 127804001 | 12780400 | 15 | Oedema |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127804001 | 12780400 | DE |
| 127804001 | 12780400 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127804001 | 12780400 | Acute kidney injury | |
| 127804001 | 12780400 | Pneumonia | |
| 127804001 | 12780400 | Therapy non-responder | |
| 127804001 | 12780400 | 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 |
|---|---|---|---|---|---|---|
| 127804001 | 12780400 | 1 | 20090427 | 20090501 | 0 | |
| 127804001 | 12780400 | 2 | 20090427 | 20090620 | 0 | |
| 127804001 | 12780400 | 3 | 20090427 | 20090610 | 0 | |
| 127804001 | 12780400 | 4 | 20090427 | 20090617 | 0 | |
| 127804001 | 12780400 | 5 | 20090427 | 20090620 | 0 | |
| 127804001 | 12780400 | 10 | 20090427 | 20090427 | 0 | |
| 127804001 | 12780400 | 11 | 20090427 | 20090620 | 0 | |
| 127804001 | 12780400 | 14 | 20090427 | 20090620 | 0 | |
| 127804001 | 12780400 | 15 | 20090427 | 20090620 | 0 |