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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126734291 | 12673429 | 1 | I | 20100312 | 20100707 | 20160822 | 20160822 | EXP | JP-SA-THYM-1001596 | AVENTIS | 0.00 | A | M | Y | 60.00000 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126734291 | 12673429 | 1 | PS | THYMOGLOBULINE | LAPINE T-LYMPHOCYTE IMMUNE GLOBULIN | 1 | Intravenous (not otherwise specified) | 150 MG, QD | 300 | MG | U | UNKNOWN | 103869 | 150 | MG | POWDER FOR SOLUTION FOR INFUSION | QD | ||
| 126734291 | 12673429 | 2 | SS | FLUDARA | FLUDARABINE PHOSPHATE | 1 | Unknown | 50 MG, QD | 300 | MG | U | U | UNKNOWN | 0 | 50 | MG | QD | ||
| 126734291 | 12673429 | 3 | SS | FLUDARA | FLUDARABINE PHOSPHATE | 1 | Unknown | 50 MG, QD | 300 | MG | U | U | UNKNOWN | 0 | 50 | MG | QD | ||
| 126734291 | 12673429 | 4 | C | FLUCONAZOLE. | FLUCONAZOLE | 1 | Unknown | UNK | U | 0 | |||||||||
| 126734291 | 12673429 | 5 | C | SULPIRIDE | SULPIRIDE | 1 | Unknown | UNK | U | 0 | |||||||||
| 126734291 | 12673429 | 6 | C | LANSOPRAZOLE. | LANSOPRAZOLE | 1 | Unknown | UNK | U | 0 | |||||||||
| 126734291 | 12673429 | 7 | C | ACICLOVIR | ACYCLOVIR | 1 | Unknown | UNK | U | 0 | |||||||||
| 126734291 | 12673429 | 8 | C | BUSULFAN. | BUSULFAN | 1 | UNK | 0 | |||||||||||
| 126734291 | 12673429 | 9 | C | TACROLIMUS. | TACROLIMUS | 1 | UNK | 0 | |||||||||||
| 126734291 | 12673429 | 10 | C | METHOTREXATE. | METHOTREXATE | 1 | UNK | 0 | |||||||||||
| 126734291 | 12673429 | 11 | C | SULFAMETHOXAZOLE-TRIMETHOPRIM (SMZ) | SULFAMETHOXAZOLETRIMETHOPRIM | 1 | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126734291 | 12673429 | 1 | Bone marrow conditioning regimen |
| 126734291 | 12673429 | 2 | Bone marrow conditioning regimen |
| 126734291 | 12673429 | 3 | Bone marrow conditioning regimen |
| 126734291 | 12673429 | 4 | Antifungal prophylaxis |
| 126734291 | 12673429 | 5 | Depression |
| 126734291 | 12673429 | 6 | Prophylaxis against gastrointestinal ulcer |
| 126734291 | 12673429 | 7 | Antiviral prophylaxis |
| 126734291 | 12673429 | 8 | Bone marrow conditioning regimen |
| 126734291 | 12673429 | 9 | Prophylaxis against graft versus host disease |
| 126734291 | 12673429 | 10 | Prophylaxis against graft versus host disease |
| 126734291 | 12673429 | 11 | Antifungal prophylaxis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126734291 | 12673429 | DE |
| 126734291 | 12673429 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126734291 | 12673429 | Acute respiratory failure | |
| 126734291 | 12673429 | Anaemia | |
| 126734291 | 12673429 | Cytomegalovirus infection | |
| 126734291 | 12673429 | Febrile neutropenia | |
| 126734291 | 12673429 | Liver disorder | |
| 126734291 | 12673429 | Neutrophil count decreased | |
| 126734291 | 12673429 | Platelet count decreased | |
| 126734291 | 12673429 | Pneumonia | |
| 126734291 | 12673429 | Pyrexia | |
| 126734291 | 12673429 | Toxoplasmosis |
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 |
|---|---|---|---|---|---|---|
| 126734291 | 12673429 | 1 | 20100312 | 20100313 | 0 | |
| 126734291 | 12673429 | 2 | 20100308 | 20100313 | 0 | |
| 126734291 | 12673429 | 3 | 20100308 | 20100313 | 0 | |
| 126734291 | 12673429 | 4 | 20100304 | 20100524 | 0 | |
| 126734291 | 12673429 | 5 | 20100219 | 20100401 | 0 | |
| 126734291 | 12673429 | 6 | 20100219 | 20100401 | 0 | |
| 126734291 | 12673429 | 7 | 20100309 | 20100401 | 0 | |
| 126734291 | 12673429 | 8 | 20100309 | 20100311 | 0 | |
| 126734291 | 12673429 | 9 | 20100314 | 20100602 | 0 | |
| 126734291 | 12673429 | 10 | 20100316 | 20100326 | 0 | |
| 126734291 | 12673429 | 11 | 20100305 | 20100313 | 0 |