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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124090142 | 12409014 | 2 | F | 20130212 | 20160630 | 20160526 | 20160706 | PER | JP-SA-2013SA116972 | AVENTIS | 0.00 | C | M | Y | 28.20000 | KG | 20160706 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124090142 | 12409014 | 1 | PS | FLUDARA | FLUDARABINE PHOSPHATE | 1 | Unknown | UNKNOWN | 20038 | ||||||||||
| 124090142 | 12409014 | 2 | SS | ENDOXAN | CYCLOPHOSPHAMIDE | 1 | Unknown | UNKNOWN | 0 | ||||||||||
| 124090142 | 12409014 | 3 | C | THYMOGLOBULINE | LAPINE T-LYMPHOCYTE IMMUNE GLOBULIN | 1 | Intravenous (not otherwise specified) | C1310NK | 0 | 35 | MG | QD | |||||||
| 124090142 | 12409014 | 4 | C | METHOTREXATE. | METHOTREXATE | 1 | Unknown | 0 | |||||||||||
| 124090142 | 12409014 | 5 | C | PROGRAF | TACROLIMUSTACROLIMUS ANHYDROUS | 1 | Unknown | 0 | |||||||||||
| 124090142 | 12409014 | 6 | C | UROMITEXAN | MESNA | 1 | Unknown | 0 | |||||||||||
| 124090142 | 12409014 | 7 | C | GRANISETRON | GRANISETRON | 1 | Unknown | 0 | |||||||||||
| 124090142 | 12409014 | 8 | C | SOLU-MEDROL | METHYLPREDNISOLONE SODIUM SUCCINATE | 1 | Unknown | 0 | |||||||||||
| 124090142 | 12409014 | 9 | C | FUNGUARD | MICAFUNGIN SODIUM | 1 | Unknown | 0 | |||||||||||
| 124090142 | 12409014 | 10 | C | FUNGUARD | MICAFUNGIN SODIUM | 1 | Unknown | 0 | |||||||||||
| 124090142 | 12409014 | 11 | C | LASIX | FUROSEMIDE | 1 | Unknown | 0 | |||||||||||
| 124090142 | 12409014 | 12 | C | ALL OTHER THERAPEUTIC PRODUCTS | UNSPECIFIED INGREDIENT | 1 | Unknown | 0 | |||||||||||
| 124090142 | 12409014 | 13 | C | CLARITIN | LORATADINE | 1 | Unknown | 0 | |||||||||||
| 124090142 | 12409014 | 14 | C | ASTRIC | ACYCLOVIR | 1 | Unknown | 0 | |||||||||||
| 124090142 | 12409014 | 15 | C | URSO | URSODIOL | 1 | Unknown | 0 | |||||||||||
| 124090142 | 12409014 | 16 | C | DIFLUCAN | FLUCONAZOLE | 1 | Unknown | 0 | |||||||||||
| 124090142 | 12409014 | 17 | C | VENOGLOBULIN | HUMAN IMMUNOGLOBULIN G | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124090142 | 12409014 | 1 | Myelodysplastic syndrome |
| 124090142 | 12409014 | 2 | Myelodysplastic syndrome |
| 124090142 | 12409014 | 3 | Bone marrow conditioning regimen |
| 124090142 | 12409014 | 4 | Prophylaxis against graft versus host disease |
| 124090142 | 12409014 | 5 | Prophylaxis against graft versus host disease |
| 124090142 | 12409014 | 6 | Prophylaxis |
| 124090142 | 12409014 | 7 | Prophylaxis of nausea and vomiting |
| 124090142 | 12409014 | 8 | Prophylaxis |
| 124090142 | 12409014 | 9 | Antifungal prophylaxis |
| 124090142 | 12409014 | 10 | Fungal infection |
| 124090142 | 12409014 | 11 | Cardiovascular event prophylaxis |
| 124090142 | 12409014 | 12 | Prophylaxis |
| 124090142 | 12409014 | 13 | Respiratory disorder |
| 124090142 | 12409014 | 14 | Antiviral prophylaxis |
| 124090142 | 12409014 | 15 | Prophylaxis |
| 124090142 | 12409014 | 16 | Antifungal prophylaxis |
| 124090142 | 12409014 | 17 | Antiviral prophylaxis |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124090142 | 12409014 | Mucous membrane disorder |
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 |
|---|---|---|---|---|---|---|
| 124090142 | 12409014 | 1 | 20130130 | 20130202 | 0 | |
| 124090142 | 12409014 | 2 | 20130130 | 20130202 | 0 | |
| 124090142 | 12409014 | 3 | 20130130 | 20130202 | 0 | |
| 124090142 | 12409014 | 4 | 20130207 | 20130212 | 0 | |
| 124090142 | 12409014 | 5 | 20130204 | 0 | ||
| 124090142 | 12409014 | 6 | 20130130 | 20130202 | 0 | |
| 124090142 | 12409014 | 7 | 20130130 | 20130216 | 0 | |
| 124090142 | 12409014 | 8 | 20130130 | 20130223 | 0 | |
| 124090142 | 12409014 | 9 | 20130130 | 20130624 | 0 | |
| 124090142 | 12409014 | 10 | 20130130 | 20130624 | 0 | |
| 124090142 | 12409014 | 11 | 20130131 | 20130220 | 0 | |
| 124090142 | 12409014 | 12 | 20130205 | 20130205 | 0 | |
| 124090142 | 12409014 | 13 | 20130130 | 0 | ||
| 124090142 | 12409014 | 14 | 20130130 | 0 | ||
| 124090142 | 12409014 | 15 | 20130130 | 0 | ||
| 124090142 | 12409014 | 16 | 20130130 | 20130529 | 0 | |
| 124090142 | 12409014 | 17 | 20130204 | 20130529 | 0 |