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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116714703 | 11671470 | 3 | F | 20131124 | 20160714 | 20151028 | 20160721 | EXP | JP-SA-2015SA169249 | AVENTIS | 23.00 | YR | A | M | Y | 66.90000 | KG | 20160721 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116714703 | 11671470 | 1 | PS | THYMOGLOBULINE | LAPINE T-LYMPHOCYTE IMMUNE GLOBULIN | 1 | Intravenous (not otherwise specified) | OVER 8 HOURS | UNK | 103869 | 165 | MG | INJECTION | ||||||
| 116714703 | 11671470 | 2 | SS | THYMOGLOBULINE | LAPINE T-LYMPHOCYTE IMMUNE GLOBULIN | 1 | Intravenous (not otherwise specified) | OVER 1 HOUR | UNK | 103869 | 2.5 | MG | INJECTION | ||||||
| 116714703 | 11671470 | 3 | SS | PROGRAF | TACROLIMUSTACROLIMUS ANHYDROUS | 1 | Unknown | UNK | 0 | ||||||||||
| 116714703 | 11671470 | 4 | SS | PREDONINE | PREDNISOLONEPREDNISOLONE ACETATEPREDNISOLONE SODIUM SUCCINATE | 1 | Unknown | UNK | 0 | ||||||||||
| 116714703 | 11671470 | 5 | SS | BUSULFEX | BUSULFAN | 1 | Unknown | NK | 0 | ||||||||||
| 116714703 | 11671470 | 6 | SS | ALKERAN | MELPHALAN | 1 | Unknown | UNK | 0 | ||||||||||
| 116714703 | 11671470 | 7 | C | TAKEPRON | LANSOPRAZOLE | 1 | 0 | ||||||||||||
| 116714703 | 11671470 | 8 | C | ALEVIATIN | PHENYTOIN SODIUM | 1 | 0 | ||||||||||||
| 116714703 | 11671470 | 9 | C | CRAVIT | LEVOFLOXACIN | 1 | 0 | ||||||||||||
| 116714703 | 11671470 | 10 | C | MYCOSYST | FLUCONAZOLE | 1 | 0 | ||||||||||||
| 116714703 | 11671470 | 11 | C | MYCOSYST | FLUCONAZOLE | 1 | 0 | ||||||||||||
| 116714703 | 11671470 | 12 | C | ZOVIRAX | ACYCLOVIR | 1 | 0 | ||||||||||||
| 116714703 | 11671470 | 13 | C | URSO | URSODIOL | 1 | 0 | ||||||||||||
| 116714703 | 11671470 | 14 | C | SOL-MELCORT | METHYLPREDNISOLONE SODIUM SUCCINATE | 1 | 0 | ||||||||||||
| 116714703 | 11671470 | 15 | C | PRODIF | FOSFLUCONAZOLE | 1 | 0 | ||||||||||||
| 116714703 | 11671470 | 16 | C | FOSCAVIR | FOSCARNET SODIUM | 1 | 0 | ||||||||||||
| 116714703 | 11671470 | 17 | C | GRAN | FILGRASTIM | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 116714703 | 11671470 | 1 | Bone marrow conditioning regimen |
| 116714703 | 11671470 | 2 | Bone marrow conditioning regimen |
| 116714703 | 11671470 | 3 | Prophylaxis against graft versus host disease |
| 116714703 | 11671470 | 7 | Prophylaxis against gastrointestinal ulcer |
| 116714703 | 11671470 | 8 | Prophylaxis |
| 116714703 | 11671470 | 9 | Infection prophylaxis |
| 116714703 | 11671470 | 10 | Antifungal prophylaxis |
| 116714703 | 11671470 | 11 | Antifungal prophylaxis |
| 116714703 | 11671470 | 12 | Prophylaxis |
| 116714703 | 11671470 | 13 | Prophylaxis |
| 116714703 | 11671470 | 14 | Prophylaxis |
| 116714703 | 11671470 | 15 | Antifungal prophylaxis |
| 116714703 | 11671470 | 16 | Human herpesvirus 6 infection |
| 116714703 | 11671470 | 17 | Neutropenia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 116714703 | 11671470 | OT |
| 116714703 | 11671470 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 116714703 | 11671470 | Cystitis haemorrhagic | |
| 116714703 | 11671470 | Cytomegalovirus viraemia | |
| 116714703 | 11671470 | Febrile neutropenia | |
| 116714703 | 11671470 | Thrombotic microangiopathy |
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 |
|---|---|---|---|---|---|---|
| 116714703 | 11671470 | 1 | 20131120 | 20131121 | 0 | |
| 116714703 | 11671470 | 2 | 20131120 | 20131120 | 0 | |
| 116714703 | 11671470 | 3 | 20131126 | 0 | ||
| 116714703 | 11671470 | 4 | 20131202 | 0 | ||
| 116714703 | 11671470 | 5 | 20131123 | 20131124 | 0 | |
| 116714703 | 11671470 | 6 | 20131124 | 20131125 | 0 | |
| 116714703 | 11671470 | 7 | 20131118 | 20131204 | 0 | |
| 116714703 | 11671470 | 8 | 20131121 | 20131125 | 0 | |
| 116714703 | 11671470 | 9 | 20131118 | 20131129 | 0 | |
| 116714703 | 11671470 | 10 | 20131118 | 20131123 | 0 | |
| 116714703 | 11671470 | 11 | 20131224 | 20140220 | 0 | |
| 116714703 | 11671470 | 12 | 20131118 | 20131129 | 0 | |
| 116714703 | 11671470 | 13 | 20131120 | 20140107 | 0 | |
| 116714703 | 11671470 | 14 | 20131120 | 20131121 | 0 | |
| 116714703 | 11671470 | 15 | 20131209 | 20131223 | 0 | |
| 116714703 | 11671470 | 16 | 20131207 | 20131214 | 0 | |
| 116714703 | 11671470 | 17 | 20131203 | 20131225 | 0 |