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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 98204935 | 9820493 | 5 | F | 20130502 | 20160916 | 20140116 | 20160921 | EXP | JP-SA-THYM-1003808 | AVENTIS | 6.00 | YR | C | M | Y | 16.00000 | KG | 20160921 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 98204935 | 9820493 | 1 | PS | THYMOGLOBULINE | LAPINE T-LYMPHOCYTE IMMUNE GLOBULIN | 1 | Intravenous (not otherwise specified) | 64 MG, QD | 320 | MG | C1310NL | 103869 | 64 | MG | POWDER FOR SOLUTION FOR INFUSION | QD | |||
| 98204935 | 9820493 | 2 | C | NEORAL | CYCLOSPORINE | 1 | Oral | 60 MG, BID | 0 | 60 | MG | BID | |||||||
| 98204935 | 9820493 | 3 | C | PREDONINE | PREDNISOLONEPREDNISOLONE ACETATEPREDNISOLONE SODIUM SUCCINATE | 1 | Oral | 5.7 MG, TID | 0 | 5.7 | MG | TID | |||||||
| 98204935 | 9820493 | 4 | C | GASTER | FAMOTIDINE | 1 | Oral | 10 MG, QD | 0 | 10 | MG | QD | |||||||
| 98204935 | 9820493 | 5 | C | BAKTAR | SULFAMETHOXAZOLETRIMETHOPRIM | 1 | Oral | 0.35 G, BID | 0 | .35 | G | BID | |||||||
| 98204935 | 9820493 | 6 | C | SOLU-MEDROL | METHYLPREDNISOLONE SODIUM SUCCINATE | 1 | 0 | ||||||||||||
| 98204935 | 9820493 | 7 | C | ATARAX-P | HYDROXYZINE HYDROCHLORIDE | 1 | 0 | ||||||||||||
| 98204935 | 9820493 | 8 | C | MEROPEN | MEROPENEM | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 98204935 | 9820493 | 1 | Myelodysplastic syndrome |
| 98204935 | 9820493 | 2 | Myelodysplastic syndrome |
| 98204935 | 9820493 | 3 | Prophylaxis |
| 98204935 | 9820493 | 4 | Prophylaxis against gastrointestinal ulcer |
| 98204935 | 9820493 | 5 | Antifungal prophylaxis |
| 98204935 | 9820493 | 6 | Prophylaxis |
| 98204935 | 9820493 | 7 | Prophylaxis |
| 98204935 | 9820493 | 8 | Infection prophylaxis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 98204935 | 9820493 | LT |
| 98204935 | 9820493 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 98204935 | 9820493 | Ascites | |
| 98204935 | 9820493 | Hepatomegaly | |
| 98204935 | 9820493 | Hepatorenal syndrome | |
| 98204935 | 9820493 | Hypoxia | |
| 98204935 | 9820493 | Jaundice | |
| 98204935 | 9820493 | Liver disorder | |
| 98204935 | 9820493 | Off label use | |
| 98204935 | 9820493 | Oliguria | |
| 98204935 | 9820493 | Pleural effusion | |
| 98204935 | 9820493 | Pyrexia | |
| 98204935 | 9820493 | Rash | |
| 98204935 | 9820493 | Renal failure | |
| 98204935 | 9820493 | Serum sickness |
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 |
|---|---|---|---|---|---|---|
| 98204935 | 9820493 | 1 | 20130423 | 20130427 | 0 | |
| 98204935 | 9820493 | 2 | 20130423 | 0 | ||
| 98204935 | 9820493 | 3 | 20130428 | 0 | ||
| 98204935 | 9820493 | 4 | 20130428 | 0 | ||
| 98204935 | 9820493 | 5 | 20130427 | 0 | ||
| 98204935 | 9820493 | 6 | 20130423 | 20130427 | 0 | |
| 98204935 | 9820493 | 7 | 20130423 | 20130427 | 0 | |
| 98204935 | 9820493 | 8 | 20130504 | 20130507 | 0 |