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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 114908983 | 11490898 | 3 | F | 20091114 | 20160817 | 20150910 | 20160822 | EXP | JP-SA-THYM-1001985 | AVENTIS | 84.00 | YR | E | F | Y | 31.00000 | KG | 20160822 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 114908983 | 11490898 | 1 | PS | THYMOGLOBULINE | LAPINE T-LYMPHOCYTE IMMUNE GLOBULIN | 1 | Intravenous (not otherwise specified) | 75 MG, QD | 375 | MG | U | UNKNOWN | 103869 | 75 | MG | POWDER FOR SOLUTION FOR INFUSION | QD | ||
| 114908983 | 11490898 | 2 | C | AMLODIPINE BESILATE | AMLODIPINE BESYLATE | 1 | Unknown | UNK | U | 0 | |||||||||
| 114908983 | 11490898 | 3 | C | CANDESARTAN CILEXETIL. | CANDESARTAN CILEXETIL | 1 | Unknown | UNK | U | 0 | |||||||||
| 114908983 | 11490898 | 4 | C | CICLOSPORIN | CYCLOSPORINE | 1 | Unknown | UNK | U | 0 | |||||||||
| 114908983 | 11490898 | 5 | C | METHYLPREDNISOLONE SODIUM SUCCINATE. | METHYLPREDNISOLONE SODIUM SUCCINATE | 1 | Unknown | UNK | U | 0 | |||||||||
| 114908983 | 11490898 | 6 | C | PREDNISOLONE ACETATE. | PREDNISOLONE ACETATE | 1 | Unknown | UNK | U | 0 | |||||||||
| 114908983 | 11490898 | 7 | C | ITRACONAZOLE. | ITRACONAZOLE | 1 | Unknown | UNK | U | 0 | |||||||||
| 114908983 | 11490898 | 8 | C | ITRACONAZOLE. | ITRACONAZOLE | 1 | Unknown | UNK | U | 0 | |||||||||
| 114908983 | 11490898 | 9 | C | MICAFUNGIN SODIUM | MICAFUNGIN SODIUM | 1 | Unknown | UNK | U | 0 | |||||||||
| 114908983 | 11490898 | 10 | C | MICAFUNGIN SODIUM | MICAFUNGIN SODIUM | 1 | Unknown | UNK | U | 0 | |||||||||
| 114908983 | 11490898 | 11 | C | FILGRASTIM | FILGRASTIM | 1 | Unknown | UNK | U | 0 | |||||||||
| 114908983 | 11490898 | 12 | C | VORICONAZOLE. | VORICONAZOLE | 1 | Unknown | UNK | U | 0 | |||||||||
| 114908983 | 11490898 | 13 | C | VORICONAZOLE. | VORICONAZOLE | 1 | Unknown | UNK | U | 0 | |||||||||
| 114908983 | 11490898 | 14 | C | MINOCYCLINE HYDROCHLORIDE. | MINOCYCLINE HYDROCHLORIDE | 1 | Unknown | UNK | 0 | ||||||||||
| 114908983 | 11490898 | 15 | C | RED BLOOD CELLS, CONCENTRATED | HUMAN RED BLOOD CELL | 1 | Unknown | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 114908983 | 11490898 | 1 | Aplastic anaemia |
| 114908983 | 11490898 | 2 | Hypertension |
| 114908983 | 11490898 | 3 | Hypertension |
| 114908983 | 11490898 | 4 | Aplastic anaemia |
| 114908983 | 11490898 | 5 | Premedication |
| 114908983 | 11490898 | 6 | Premedication |
| 114908983 | 11490898 | 7 | Prophylaxis |
| 114908983 | 11490898 | 8 | Aspergillus infection |
| 114908983 | 11490898 | 9 | Prophylaxis |
| 114908983 | 11490898 | 10 | Aspergillus infection |
| 114908983 | 11490898 | 11 | Aplastic anaemia |
| 114908983 | 11490898 | 12 | Prophylaxis |
| 114908983 | 11490898 | 13 | Aspergillus infection |
| 114908983 | 11490898 | 14 | Prophylaxis |
| 114908983 | 11490898 | 15 | Aplastic anaemia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 114908983 | 11490898 | OT |
| 114908983 | 11490898 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 114908983 | 11490898 | Bronchial haemorrhage | |
| 114908983 | 11490898 | Cardiac failure congestive | |
| 114908983 | 11490898 | Febrile neutropenia | |
| 114908983 | 11490898 | Gastrointestinal haemorrhage | |
| 114908983 | 11490898 | Shock haemorrhagic | |
| 114908983 | 11490898 | Systemic mycosis |
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 |
|---|---|---|---|---|---|---|
| 114908983 | 11490898 | 1 | 20091109 | 20091113 | 0 | |
| 114908983 | 11490898 | 2 | 20100102 | 0 | ||
| 114908983 | 11490898 | 3 | 20100102 | 0 | ||
| 114908983 | 11490898 | 4 | 20091031 | 20091228 | 0 | |
| 114908983 | 11490898 | 5 | 20091109 | 20091119 | 0 | |
| 114908983 | 11490898 | 6 | 20091120 | 20091126 | 0 | |
| 114908983 | 11490898 | 7 | 20091122 | 20091126 | 0 | |
| 114908983 | 11490898 | 8 | 20091122 | 20091126 | 0 | |
| 114908983 | 11490898 | 9 | 20091127 | 20091209 | 0 | |
| 114908983 | 11490898 | 10 | 20091127 | 20091209 | 0 | |
| 114908983 | 11490898 | 11 | 20091201 | 20091225 | 0 | |
| 114908983 | 11490898 | 12 | 20091215 | 20091225 | 0 | |
| 114908983 | 11490898 | 13 | 20091215 | 20091225 | 0 | |
| 114908983 | 11490898 | 14 | 20091218 | 20091225 | 0 | |
| 114908983 | 11490898 | 15 | 20091023 | 20100105 | 0 |