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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 114545523 | 11454552 | 3 | F | 20120407 | 20160920 | 20150903 | 20160927 | EXP | JP-SA-2015SA132369 | AVENTIS | 11.00 | YR | T | M | Y | 54.60000 | KG | 20160927 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 114545523 | 11454552 | 1 | SS | THYMOGLOBULINE | LAPINE T-LYMPHOCYTE IMMUNE GLOBULIN | 1 | Intravenous (not otherwise specified) | OVER 14 HOURS, | D | UNKNOWN | 0 | 67.5 | MG | INJECTION | QD | ||||
| 114545523 | 11454552 | 2 | SS | THYMOGLOBULINE | LAPINE T-LYMPHOCYTE IMMUNE GLOBULIN | 1 | Intravenous (not otherwise specified) | 12 HOURS AND A HALF. | D | UNKNOWN | 0 | 67.5 | MG | INJECTION | QD | ||||
| 114545523 | 11454552 | 3 | SS | THYMOGLOBULINE | LAPINE T-LYMPHOCYTE IMMUNE GLOBULIN | 1 | Intravenous (not otherwise specified) | 12 HOURS AND A HALF. | D | UNKNWON | 0 | 67.5 | MG | INJECTION | QD | ||||
| 114545523 | 11454552 | 4 | SS | THYMOGLOBULINE | LAPINE T-LYMPHOCYTE IMMUNE GLOBULIN | 1 | Intravenous (not otherwise specified) | 12 HOURS AND A HALF. | D | UNKNOWN | 0 | 67.5 | MG | INJECTION | QD | ||||
| 114545523 | 11454552 | 5 | PS | FLUDARA | FLUDARABINE PHOSPHATE | 1 | Intravenous (not otherwise specified) | DOSE:37 MG/BODY/DAY | D | UNKNOWN | 20038 | INJECTION | QD | ||||||
| 114545523 | 11454552 | 6 | SS | ENDOXAN | CYCLOPHOSPHAMIDE | 1 | Intravenous (not otherwise specified) | D | UNKNOWN | 0 | |||||||||
| 114545523 | 11454552 | 7 | SS | PROGRAF | TACROLIMUSTACROLIMUS ANHYDROUS | 1 | Oral | D | UNKNOWN | 0 | CAPSULE | ||||||||
| 114545523 | 11454552 | 8 | C | UROMITEXAN | MESNA | 1 | 0 | ||||||||||||
| 114545523 | 11454552 | 9 | C | MANNITOL. | MANNITOL | 1 | 0 | ||||||||||||
| 114545523 | 11454552 | 10 | C | SOLU-MEDROL | METHYLPREDNISOLONE SODIUM SUCCINATE | 1 | 0 | ||||||||||||
| 114545523 | 11454552 | 11 | C | CHLOR-TRIMETON | CHLORPHENIRAMINE MALEATE | 1 | 0 | ||||||||||||
| 114545523 | 11454552 | 12 | C | KENKETSU VENILON | 2 | 0 | |||||||||||||
| 114545523 | 11454552 | 13 | C | PROGRAF | TACROLIMUSTACROLIMUS ANHYDROUS | 1 | Intravenous (not otherwise specified) | 0 | INJECTION | ||||||||||
| 114545523 | 11454552 | 14 | C | FUNGUARD | MICAFUNGIN SODIUM | 1 | Intravenous (not otherwise specified) | 0 | |||||||||||
| 114545523 | 11454552 | 15 | C | NEUTROGIN | LENOGRASTIM | 1 | 0 | ||||||||||||
| 114545523 | 11454552 | 16 | C | BACCIDAL | NORFLOXACIN | 1 | 0 | ||||||||||||
| 114545523 | 11454552 | 17 | C | ZOVIRAX | ACYCLOVIR | 1 | 0 | TABLET | |||||||||||
| 114545523 | 11454552 | 18 | C | RITUXAN | RITUXIMAB | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 114545523 | 11454552 | 1 | Bone marrow conditioning regimen |
| 114545523 | 11454552 | 2 | Bone marrow conditioning regimen |
| 114545523 | 11454552 | 3 | Bone marrow conditioning regimen |
| 114545523 | 11454552 | 4 | Bone marrow conditioning regimen |
| 114545523 | 11454552 | 5 | Bone marrow conditioning regimen |
| 114545523 | 11454552 | 6 | Bone marrow conditioning regimen |
| 114545523 | 11454552 | 7 | Prophylaxis against graft versus host disease |
| 114545523 | 11454552 | 8 | Bone marrow transplant |
| 114545523 | 11454552 | 9 | Prophylaxis |
| 114545523 | 11454552 | 10 | Prophylaxis |
| 114545523 | 11454552 | 11 | Prophylaxis |
| 114545523 | 11454552 | 12 | Prophylaxis |
| 114545523 | 11454552 | 13 | Prophylaxis against graft versus host disease |
| 114545523 | 11454552 | 14 | Antifungal prophylaxis |
| 114545523 | 11454552 | 16 | Infection prophylaxis |
| 114545523 | 11454552 | 17 | Antiviral prophylaxis |
| 114545523 | 11454552 | 18 | Prophylaxis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 114545523 | 11454552 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 114545523 | 11454552 | Engraftment syndrome | |
| 114545523 | 11454552 | Febrile neutropenia | |
| 114545523 | 11454552 | Pyrexia |
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 |
|---|---|---|---|---|---|---|
| 114545523 | 11454552 | 1 | 20120407 | 20120407 | 0 | |
| 114545523 | 11454552 | 2 | 20120408 | 20120408 | 0 | |
| 114545523 | 11454552 | 3 | 20120409 | 20120409 | 0 | |
| 114545523 | 11454552 | 4 | 20120410 | 20120410 | 0 | |
| 114545523 | 11454552 | 5 | 20120407 | 20120410 | 0 | |
| 114545523 | 11454552 | 6 | 20120407 | 20120410 | 0 | |
| 114545523 | 11454552 | 7 | 20120522 | 20120622 | 0 | |
| 114545523 | 11454552 | 8 | 20120407 | 20120410 | 0 | |
| 114545523 | 11454552 | 9 | 20120407 | 20120411 | 0 | |
| 114545523 | 11454552 | 10 | 20120407 | 20120410 | 0 | |
| 114545523 | 11454552 | 11 | 20120407 | 20120410 | 0 | |
| 114545523 | 11454552 | 12 | 20120412 | 20120607 | 0 | |
| 114545523 | 11454552 | 13 | 20120411 | 20120521 | 0 | |
| 114545523 | 11454552 | 14 | 20120411 | 20120522 | 0 | |
| 114545523 | 11454552 | 15 | 20120417 | 20120504 | 0 | |
| 114545523 | 11454552 | 16 | 20120405 | 20120502 | 0 | |
| 114545523 | 11454552 | 17 | 20120405 | 20120523 | 0 | |
| 114545523 | 11454552 | 18 | 20120405 | 20120405 | 0 |