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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127171801 | 12717180 | 1 | I | 20110316 | 20111026 | 20160906 | 20160906 | EXP | JP-SA-THYM-1002861 | AVENTIS | 0.00 | A | Y | 22.00000 | KG | 20160906 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127171801 | 12717180 | 1 | PS | THYMOGLOBULINE | LAPINE T-LYMPHOCYTE IMMUNE GLOBULIN | 1 | Intravenous (not otherwise specified) | 50 MG, QD | 300 | MG | U | UNKNOWN | 103869 | 50 | MG | POWDER FOR SOLUTION FOR INFUSION | QD | ||
| 127171801 | 12717180 | 2 | SS | THYMOGLOBULINE | LAPINE T-LYMPHOCYTE IMMUNE GLOBULIN | 1 | Intravenous (not otherwise specified) | 50 MG, QD | 300 | MG | U | UNKNOWN | 103869 | 50 | MG | POWDER FOR SOLUTION FOR INFUSION | QD | ||
| 127171801 | 12717180 | 3 | SS | THYMOGLOBULINE | LAPINE T-LYMPHOCYTE IMMUNE GLOBULIN | 1 | Intravenous (not otherwise specified) | 100 MG, QD | 300 | MG | U | UNKNOWN | 103869 | 100 | MG | POWDER FOR SOLUTION FOR INFUSION | QD | ||
| 127171801 | 12717180 | 4 | SS | THYMOGLOBULINE | LAPINE T-LYMPHOCYTE IMMUNE GLOBULIN | 1 | Intravenous (not otherwise specified) | 100 MG, QD | 300 | MG | U | UNKNOWN | 103869 | 100 | MG | POWDER FOR SOLUTION FOR INFUSION | QD | ||
| 127171801 | 12717180 | 5 | C | FLUDARABINE PHOSPHATE. | FLUDARABINE PHOSPHATE | 1 | UNK | 0 | |||||||||||
| 127171801 | 12717180 | 6 | C | MELPHALAN | MELPHALAN | 1 | UNK | 0 | |||||||||||
| 127171801 | 12717180 | 7 | C | BACTRIM | SULFAMETHOXAZOLETRIMETHOPRIM | 1 | UNK | 0 | |||||||||||
| 127171801 | 12717180 | 8 | C | METHOTREXATE. | METHOTREXATE | 1 | UNK | 0 | |||||||||||
| 127171801 | 12717180 | 9 | C | TACROLIMUS. | TACROLIMUS | 1 | UNK | 0 | |||||||||||
| 127171801 | 12717180 | 10 | C | GRAN | FILGRASTIM | 1 | UNK | 0 | |||||||||||
| 127171801 | 12717180 | 11 | C | CALCIUM FOLINATE | LEUCOVORIN CALCIUM | 1 | UNK | 0 | |||||||||||
| 127171801 | 12717180 | 12 | C | FLUCONAZOLE. | FLUCONAZOLE | 1 | UNK | 0 | |||||||||||
| 127171801 | 12717180 | 13 | C | ACICLOVIR | ACYCLOVIR | 1 | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127171801 | 12717180 | 1 | Bone marrow conditioning regimen |
| 127171801 | 12717180 | 2 | Prophylaxis against graft versus host disease |
| 127171801 | 12717180 | 3 | Bone marrow conditioning regimen |
| 127171801 | 12717180 | 4 | Prophylaxis against graft versus host disease |
| 127171801 | 12717180 | 5 | Bone marrow conditioning regimen |
| 127171801 | 12717180 | 6 | Bone marrow conditioning regimen |
| 127171801 | 12717180 | 7 | Infection prophylaxis |
| 127171801 | 12717180 | 8 | Prophylaxis against graft versus host disease |
| 127171801 | 12717180 | 9 | Prophylaxis against graft versus host disease |
| 127171801 | 12717180 | 10 | Infection prophylaxis |
| 127171801 | 12717180 | 11 | Prophylaxis |
| 127171801 | 12717180 | 12 | Infection prophylaxis |
| 127171801 | 12717180 | 13 | Infection prophylaxis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127171801 | 12717180 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127171801 | 12717180 | Acute graft versus host disease | |
| 127171801 | 12717180 | Cytomegalovirus viraemia | |
| 127171801 | 12717180 | Gastroenteritis rotavirus |
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 |
|---|---|---|---|---|---|---|
| 127171801 | 12717180 | 1 | 20110222 | 20110225 | 0 | |
| 127171801 | 12717180 | 2 | 20110222 | 20110225 | 0 | |
| 127171801 | 12717180 | 3 | 20110307 | 20110307 | 0 | |
| 127171801 | 12717180 | 4 | 20110307 | 20110307 | 0 | |
| 127171801 | 12717180 | 5 | 20110222 | 20110225 | 0 | |
| 127171801 | 12717180 | 6 | 20110226 | 20110227 | 0 | |
| 127171801 | 12717180 | 7 | 20110220 | 20110228 | 0 | |
| 127171801 | 12717180 | 8 | 20110303 | 20110313 | 0 | |
| 127171801 | 12717180 | 9 | 20110301 | 0 | ||
| 127171801 | 12717180 | 10 | 20110307 | 20110320 | 0 | |
| 127171801 | 12717180 | 11 | 20110304 | 20110314 | 0 | |
| 127171801 | 12717180 | 12 | 20110221 | 0 | ||
| 127171801 | 12717180 | 13 | 20110221 | 0 |