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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126073111 | 12607311 | 1 | I | 20100517 | 20101230 | 20160729 | 20160729 | EXP | JP-SA-THYM-1002247 | AVENTIS | 43.00 | YR | A | F | Y | 54.00000 | KG | 20160729 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126073111 | 12607311 | 1 | PS | THYMOGLOBULINE | LAPINE T-LYMPHOCYTE IMMUNE GLOBULIN | 1 | Intravenous (not otherwise specified) | 137 MG, QD | 137 | MG | U | C9045ND | 103869 | 137 | MG | POWDER FOR SOLUTION FOR INFUSION | QD | ||
| 126073111 | 12607311 | 2 | SS | FLUDARA | FLUDARABINE PHOSPHATE | 1 | Unknown | UNK | UNKNOWN | 0 | 47.1 | MG | POWDER FOR SOLUTION FOR INFUSION | QD | |||||
| 126073111 | 12607311 | 3 | C | ITRACONAZOLE. | ITRACONAZOLE | 1 | UNK | 0 | |||||||||||
| 126073111 | 12607311 | 4 | C | ITRACONAZOLE. | ITRACONAZOLE | 1 | UNK | 0 | |||||||||||
| 126073111 | 12607311 | 5 | C | ACICLOVIR | ACYCLOVIR | 1 | UNK | 0 | |||||||||||
| 126073111 | 12607311 | 6 | C | ACICLOVIR | ACYCLOVIR | 1 | UNK | 0 | |||||||||||
| 126073111 | 12607311 | 7 | C | BACTRIM | SULFAMETHOXAZOLETRIMETHOPRIM | 1 | UNK | 0 | |||||||||||
| 126073111 | 12607311 | 8 | C | CEFAZOLIN SODIUM. | CEFAZOLIN SODIUM | 1 | UNK | 0 | |||||||||||
| 126073111 | 12607311 | 9 | C | METHOTREXATE. | METHOTREXATE | 1 | UNK | 0 | |||||||||||
| 126073111 | 12607311 | 10 | C | PREDNISOLONE ACETATE. | PREDNISOLONE ACETATE | 1 | UNK | 0 | |||||||||||
| 126073111 | 12607311 | 11 | C | GRANISETRON HYDROCHLORIDE. | GRANISETRON HYDROCHLORIDE | 1 | UNK | 0 | |||||||||||
| 126073111 | 12607311 | 12 | C | ETOPOSIDE. | ETOPOSIDE | 1 | UNK | 0 | |||||||||||
| 126073111 | 12607311 | 13 | C | BUSULFAN. | BUSULFAN | 1 | UNK | 0 | |||||||||||
| 126073111 | 12607311 | 14 | C | MELPHALAN | MELPHALAN | 1 | UNK | 0 | |||||||||||
| 126073111 | 12607311 | 15 | C | METHYLPREDNISOLONE SODIUM SUCCINATE. | METHYLPREDNISOLONE SODIUM SUCCINATE | 1 | UNK | 0 | |||||||||||
| 126073111 | 12607311 | 16 | C | TACROLIMUS. | TACROLIMUS | 1 | UNK | 0 | |||||||||||
| 126073111 | 12607311 | 17 | C | PIPERACILLIN SODIUM | PIPERACILLIN SODIUM | 1 | UNK | 0 | |||||||||||
| 126073111 | 12607311 | 18 | C | SOSEGON | PENTAZOCINE | 1 | UNK | 0 | |||||||||||
| 126073111 | 12607311 | 19 | C | FOSCAVIR | FOSCARNET SODIUM | 1 | UNK | 0 | |||||||||||
| 126073111 | 12607311 | 20 | C | PENTCILLIN | PIPERACILLIN SODIUM | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126073111 | 12607311 | 1 | Bone marrow conditioning regimen |
| 126073111 | 12607311 | 2 | Acute myeloid leukaemia |
| 126073111 | 12607311 | 3 | Prophylaxis |
| 126073111 | 12607311 | 4 | Prophylaxis |
| 126073111 | 12607311 | 5 | Prophylaxis |
| 126073111 | 12607311 | 6 | Prophylaxis |
| 126073111 | 12607311 | 7 | Prophylaxis |
| 126073111 | 12607311 | 8 | Febrile neutropenia |
| 126073111 | 12607311 | 9 | Prophylaxis |
| 126073111 | 12607311 | 10 | Acute myeloid leukaemia |
| 126073111 | 12607311 | 11 | Acute myeloid leukaemia |
| 126073111 | 12607311 | 12 | Acute myeloid leukaemia |
| 126073111 | 12607311 | 13 | Acute myeloid leukaemia |
| 126073111 | 12607311 | 14 | Acute myeloid leukaemia |
| 126073111 | 12607311 | 15 | Prophylaxis against graft versus host disease |
| 126073111 | 12607311 | 16 | Prophylaxis |
| 126073111 | 12607311 | 17 | Febrile neutropenia |
| 126073111 | 12607311 | 18 | Oral pain |
| 126073111 | 12607311 | 19 | Prophylaxis |
| 126073111 | 12607311 | 20 | Febrile neutropenia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126073111 | 12607311 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126073111 | 12607311 | Cystitis haemorrhagic | |
| 126073111 | 12607311 | Leukoencephalopathy |
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 |
|---|---|---|---|---|---|---|
| 126073111 | 12607311 | 1 | 20100420 | 20100420 | 0 | |
| 126073111 | 12607311 | 2 | 20100415 | 20100420 | 0 | |
| 126073111 | 12607311 | 3 | 20100414 | 20100428 | 0 | |
| 126073111 | 12607311 | 4 | 20100423 | 0 | ||
| 126073111 | 12607311 | 5 | 20100414 | 20100428 | 0 | |
| 126073111 | 12607311 | 6 | 20100423 | 20100506 | 0 | |
| 126073111 | 12607311 | 7 | 20100414 | 0 | ||
| 126073111 | 12607311 | 8 | 20100408 | 20100410 | 0 | |
| 126073111 | 12607311 | 9 | 20100412 | 0 | ||
| 126073111 | 12607311 | 10 | 20100412 | 0 | ||
| 126073111 | 12607311 | 11 | 20100415 | 20100420 | 0 | |
| 126073111 | 12607311 | 12 | 20100415 | 20100416 | 0 | |
| 126073111 | 12607311 | 13 | 20100417 | 20100419 | 0 | |
| 126073111 | 12607311 | 14 | 20100419 | 20100420 | 0 | |
| 126073111 | 12607311 | 15 | 20100420 | 0 | ||
| 126073111 | 12607311 | 16 | 20100421 | 0 | ||
| 126073111 | 12607311 | 17 | 20100421 | 20100529 | 0 | |
| 126073111 | 12607311 | 18 | 20100422 | 20100422 | 0 | |
| 126073111 | 12607311 | 19 | 20100530 | 20100605 | 0 |