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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126811311 | 12681131 | 1 | I | 20130218 | 20130227 | 20160824 | 20160824 | EXP | JP-SA-THYM-1003672 | AVENTIS | 74.00 | YR | E | F | Y | 53.20000 | KG | 20160824 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126811311 | 12681131 | 1 | PS | THYMOGLOBULINE | LAPINE T-LYMPHOCYTE IMMUNE GLOBULIN | 1 | Intravenous (not otherwise specified) | 213 MG, UNK | 852 | MG | Y | UNKNOWN | 103869 | 200 | MG | POWDER FOR SOLUTION FOR INFUSION | QD | ||
| 126811311 | 12681131 | 2 | C | PREDNISOLONE. | PREDNISOLONE | 1 | Oral | 0 | TABLET | ||||||||||
| 126811311 | 12681131 | 3 | C | PREDNISOLONE. | PREDNISOLONE | 1 | Oral | 0 | TABLET | ||||||||||
| 126811311 | 12681131 | 4 | C | NEORAL | CYCLOSPORINE | 1 | Oral | 0 | |||||||||||
| 126811311 | 12681131 | 5 | C | MYSLEE | ZOLPIDEM TARTRATE | 1 | 0 | ||||||||||||
| 126811311 | 12681131 | 6 | C | HACHIAZULE | 2 | 0 | GARGLE | ||||||||||||
| 126811311 | 12681131 | 7 | C | TAKEPRON OD | LANSOPRAZOLE | 1 | Oral | 0 | TABLET | ||||||||||
| 126811311 | 12681131 | 8 | C | DIFLUCAN | FLUCONAZOLE | 1 | Oral | 0 | CAPSULE | ||||||||||
| 126811311 | 12681131 | 9 | C | BAKTAR | SULFAMETHOXAZOLETRIMETHOPRIM | 1 | Oral | 0 | |||||||||||
| 126811311 | 12681131 | 10 | C | GRAN | FILGRASTIM | 1 | SYRINGE | 0 | |||||||||||
| 126811311 | 12681131 | 11 | C | GRAN | FILGRASTIM | 1 | SYRINGE | 0 | |||||||||||
| 126811311 | 12681131 | 12 | C | ELNEOPA NO 1 | 2 | 0 | |||||||||||||
| 126811311 | 12681131 | 13 | C | SOLU-MEDROL | METHYLPREDNISOLONE SODIUM SUCCINATE | 1 | 0 | ||||||||||||
| 126811311 | 12681131 | 14 | C | POLARAMINE | DEXCHLORPHENIRAMINE MALEATE | 1 | 0 | INJECTION | |||||||||||
| 126811311 | 12681131 | 15 | C | CEFOTAXIME | CEFOTAXIME SODIUM | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126811311 | 12681131 | 1 | Aplastic anaemia |
| 126811311 | 12681131 | 2 | Aplastic anaemia |
| 126811311 | 12681131 | 3 | Prophylaxis |
| 126811311 | 12681131 | 4 | Aplastic anaemia |
| 126811311 | 12681131 | 5 | Prophylaxis |
| 126811311 | 12681131 | 6 | Stomatitis |
| 126811311 | 12681131 | 7 | Prophylaxis |
| 126811311 | 12681131 | 8 | Prophylaxis |
| 126811311 | 12681131 | 9 | Prophylaxis |
| 126811311 | 12681131 | 10 | Aplastic anaemia |
| 126811311 | 12681131 | 11 | Prophylaxis |
| 126811311 | 12681131 | 12 | Prophylaxis |
| 126811311 | 12681131 | 13 | Prophylaxis |
| 126811311 | 12681131 | 14 | Prophylaxis |
| 126811311 | 12681131 | 15 | Prophylaxis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126811311 | 12681131 | HO |
| 126811311 | 12681131 | DE |
| 126811311 | 12681131 | LT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126811311 | 12681131 | Anaemia | |
| 126811311 | 12681131 | Blood pressure decreased | |
| 126811311 | 12681131 | Chest pain | |
| 126811311 | 12681131 | Chills | |
| 126811311 | 12681131 | Diarrhoea | |
| 126811311 | 12681131 | Gastrointestinal haemorrhage | |
| 126811311 | 12681131 | Malaise | |
| 126811311 | 12681131 | Melaena | |
| 126811311 | 12681131 | Nausea | |
| 126811311 | 12681131 | Platelet count decreased | |
| 126811311 | 12681131 | Pyrexia | |
| 126811311 | 12681131 | Sinus tachycardia | |
| 126811311 | 12681131 | Tachycardia | |
| 126811311 | 12681131 | Urticaria | |
| 126811311 | 12681131 | Vomiting | |
| 126811311 | 12681131 | 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 |
|---|---|---|---|---|---|---|
| 126811311 | 12681131 | 1 | 20130218 | 20130221 | 0 | |
| 126811311 | 12681131 | 2 | 20130205 | 20130221 | 0 | |
| 126811311 | 12681131 | 3 | 20130205 | 20130221 | 0 | |
| 126811311 | 12681131 | 4 | 20130218 | 20130221 | 0 | |
| 126811311 | 12681131 | 5 | 20130117 | 20130221 | 0 | |
| 126811311 | 12681131 | 6 | 20130118 | 20130221 | 0 | |
| 126811311 | 12681131 | 7 | 20130205 | 20130221 | 0 | |
| 126811311 | 12681131 | 8 | 20130205 | 20130221 | 0 | |
| 126811311 | 12681131 | 9 | 20130205 | 20130221 | 0 | |
| 126811311 | 12681131 | 10 | 20130218 | 20130221 | 0 | |
| 126811311 | 12681131 | 11 | 20130218 | 20130221 | 0 | |
| 126811311 | 12681131 | 12 | 20130215 | 20130221 | 0 | |
| 126811311 | 12681131 | 13 | 20130218 | 20130221 | 0 | |
| 126811311 | 12681131 | 14 | 20130218 | 20130221 | 0 | |
| 126811311 | 12681131 | 15 | 20130221 | 20130221 | 0 |