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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126781271 | 12678127 | 1 | I | 20101211 | 20111011 | 20160823 | 20160823 | EXP | JP-SA-THYM-1002836 | AVENTIS | 0.00 | A | F | Y | 50.00000 | KG | 20160823 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126781271 | 12678127 | 1 | SS | THYMOGLOBULIN | LAPINE T-LYMPHOCYTE IMMUNE GLOBULIN | 1 | Intravenous (not otherwise specified) | 60 MG, QD | 120 | MG | U | UNKNOWN | 0 | 60 | MG | POWDER FOR SOLUTION FOR INFUSION | QD | ||
| 126781271 | 12678127 | 2 | PS | FLUDARA | FLUDARABINE PHOSPHATE | 1 | Unknown | 50 MG, QD, 5 TIMES | 300 | MG | U | UNKNOWN | 20038 | 50 | MG | POWDER FOR SOLUTION FOR INFUSION | QD | ||
| 126781271 | 12678127 | 3 | C | SULFAMETHOPRIM | SULFAMETHOXAZOLE | 1 | Unknown | UNK | 0 | ||||||||||
| 126781271 | 12678127 | 4 | C | SULFAMETHOPRIM | SULFAMETHOXAZOLE | 1 | Unknown | UNK | 0 | ||||||||||
| 126781271 | 12678127 | 5 | C | LEVOFLOXACIN. | LEVOFLOXACIN | 1 | Unknown | UNK | 0 | ||||||||||
| 126781271 | 12678127 | 6 | C | ITRACONAZOLE. | ITRACONAZOLE | 1 | Unknown | UNK | 0 | ||||||||||
| 126781271 | 12678127 | 7 | C | BUSULFAN. | BUSULFAN | 1 | Unknown | UNK | U | 0 | |||||||||
| 126781271 | 12678127 | 8 | C | ACICLOVIR | ACYCLOVIR | 1 | Unknown | UNK | 0 | ||||||||||
| 126781271 | 12678127 | 9 | C | TACROLIMUS. | TACROLIMUS | 1 | Unknown | UNK | 0 | ||||||||||
| 126781271 | 12678127 | 10 | C | METHOTREXATE. | METHOTREXATE | 1 | Unknown | UNK | 0 | ||||||||||
| 126781271 | 12678127 | 11 | C | LANSOPRAZOLE. | LANSOPRAZOLE | 1 | Unknown | UNK | 0 | ||||||||||
| 126781271 | 12678127 | 12 | C | RED BLOOD CELLS, CONCENTRATED | HUMAN RED BLOOD CELL | 1 | Unknown | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126781271 | 12678127 | 1 | Bone marrow conditioning regimen |
| 126781271 | 12678127 | 2 | Acute myeloid leukaemia |
| 126781271 | 12678127 | 3 | Antifungal prophylaxis |
| 126781271 | 12678127 | 4 | Antifungal prophylaxis |
| 126781271 | 12678127 | 5 | Antibiotic prophylaxis |
| 126781271 | 12678127 | 6 | Antifungal prophylaxis |
| 126781271 | 12678127 | 7 | Acute myeloid leukaemia |
| 126781271 | 12678127 | 8 | Antiviral prophylaxis |
| 126781271 | 12678127 | 9 | Prophylaxis against graft versus host disease |
| 126781271 | 12678127 | 10 | Prophylaxis against graft versus host disease |
| 126781271 | 12678127 | 11 | Prophylaxis against gastrointestinal ulcer |
| 126781271 | 12678127 | 12 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126781271 | 12678127 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126781271 | 12678127 | Acute graft versus host disease | |
| 126781271 | 12678127 | Bronchopulmonary aspergillosis | |
| 126781271 | 12678127 | Febrile neutropenia | |
| 126781271 | 12678127 | Neutropenia |
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 |
|---|---|---|---|---|---|---|
| 126781271 | 12678127 | 1 | 20101211 | 20101212 | 0 | |
| 126781271 | 12678127 | 2 | 20101207 | 20101212 | 0 | |
| 126781271 | 12678127 | 3 | 20101126 | 20101212 | 0 | |
| 126781271 | 12678127 | 4 | 20110126 | 0 | ||
| 126781271 | 12678127 | 5 | 20101119 | 20101227 | 0 | |
| 126781271 | 12678127 | 6 | 20101204 | 20101223 | 0 | |
| 126781271 | 12678127 | 7 | 20101207 | 20101210 | 0 | |
| 126781271 | 12678127 | 8 | 20101207 | 20101227 | 0 | |
| 126781271 | 12678127 | 9 | 20101213 | 20101220 | 0 | |
| 126781271 | 12678127 | 10 | 20101215 | 20101220 | 0 | |
| 126781271 | 12678127 | 11 | 20101119 | 0 | ||
| 126781271 | 12678127 | 12 | 20101208 | 20110214 | 0 |