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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 104598115 | 10459811 | 5 | F | 20130907 | 20160908 | 20140917 | 20160915 | EXP | JP-SA-2014SA122399 | AVENTIS | 6.00 | YR | C | M | Y | 20.00000 | KG | 20160915 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 104598115 | 10459811 | 1 | PS | THYMOGLOBULINE | LAPINE T-LYMPHOCYTE IMMUNE GLOBULIN | 1 | Intravenous (not otherwise specified) | UNKNOWN | 103869 | 72.5 | MG | POWDER FOR SOLUTION FOR INFUSION | QD | ||||||
| 104598115 | 10459811 | 2 | SS | THYMOGLOBULINE | LAPINE T-LYMPHOCYTE IMMUNE GLOBULIN | 1 | Intravenous (not otherwise specified) | UNKNOWN | 103869 | 72.5 | MG | POWDER FOR SOLUTION FOR INFUSION | QD | ||||||
| 104598115 | 10459811 | 3 | SS | FLUDARA | FLUDARABINE PHOSPHATE | 1 | Unknown | UNK | 0 | 24 | MG | QD | |||||||
| 104598115 | 10459811 | 4 | SS | FLUDARA | FLUDARABINE PHOSPHATE | 1 | Intravenous (not otherwise specified) | STRENGTH: 50 MG | UNK | 0 | INJECTION | ||||||||
| 104598115 | 10459811 | 5 | SS | ALKERAN | MELPHALAN | 1 | Unknown | UNKNOWN | 0 | ||||||||||
| 104598115 | 10459811 | 6 | SS | PROGRAF | TACROLIMUSTACROLIMUS ANHYDROUS | 1 | Unknown | UNKNOWN | 0 | ||||||||||
| 104598115 | 10459811 | 7 | SS | PROGRAF | TACROLIMUSTACROLIMUS ANHYDROUS | 1 | Unknown | UNKNOWN | 0 | ||||||||||
| 104598115 | 10459811 | 8 | SS | VANCOMYCIN HYDROCHLORIDE. | VANCOMYCIN HYDROCHLORIDE | 1 | Unknown | UNK | 0 | ||||||||||
| 104598115 | 10459811 | 9 | SS | VANCOMYCIN HYDROCHLORIDE. | VANCOMYCIN HYDROCHLORIDE | 1 | Unknown | UNK | 0 | ||||||||||
| 104598115 | 10459811 | 10 | SS | PREDONINE | PREDNISOLONEPREDNISOLONE ACETATEPREDNISOLONE SODIUM SUCCINATE | 1 | Unknown | UNKNOWN | 0 | ||||||||||
| 104598115 | 10459811 | 11 | SS | BUSULFEX | BUSULFAN | 1 | Unknown | UNK | 0 | ||||||||||
| 104598115 | 10459811 | 12 | SS | ACICLOVIR | ACYCLOVIR | 1 | Unknown | UNKNOWN | 0 | ||||||||||
| 104598115 | 10459811 | 13 | C | KYTRIL | GRANISETRON HYDROCHLORIDE | 1 | Unknown | 0 | |||||||||||
| 104598115 | 10459811 | 14 | C | SOL-MELCORT | METHYLPREDNISOLONE SODIUM SUCCINATE | 1 | 0 | ||||||||||||
| 104598115 | 10459811 | 15 | C | FUNGUARD | MICAFUNGIN SODIUM | 1 | 0 | ||||||||||||
| 104598115 | 10459811 | 16 | C | ORGARAN | DANAPAROID SODIUM | 1 | 0 | ||||||||||||
| 104598115 | 10459811 | 17 | C | VENOGLOBULIN IH | HUMAN IMMUNOGLOBULIN G | 1 | 0 | ||||||||||||
| 104598115 | 10459811 | 18 | C | METHOTREXATE. | METHOTREXATE | 1 | 0 | ||||||||||||
| 104598115 | 10459811 | 19 | C | NEUART | ANTITHROMBIN III HUMAN | 1 | 0 | ||||||||||||
| 104598115 | 10459811 | 20 | C | LASTET | ETOPOSIDE | 1 | 0 | ||||||||||||
| 104598115 | 10459811 | 21 | C | THYRADIN-S | LEVOTHYROXINE | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 104598115 | 10459811 | 1 | Bone marrow conditioning regimen |
| 104598115 | 10459811 | 2 | Pyrexia |
| 104598115 | 10459811 | 3 | Acute myeloid leukaemia |
| 104598115 | 10459811 | 4 | Acute myeloid leukaemia |
| 104598115 | 10459811 | 5 | Bone marrow conditioning regimen |
| 104598115 | 10459811 | 6 | Prophylaxis against graft versus host disease |
| 104598115 | 10459811 | 7 | Immunosuppression |
| 104598115 | 10459811 | 8 | Bacteraemia |
| 104598115 | 10459811 | 9 | Bacteraemia |
| 104598115 | 10459811 | 10 | Prophylaxis against graft versus host disease |
| 104598115 | 10459811 | 12 | Infection prophylaxis |
| 104598115 | 10459811 | 13 | Prophylaxis of nausea and vomiting |
| 104598115 | 10459811 | 14 | Prophylaxis |
| 104598115 | 10459811 | 15 | Infection prophylaxis |
| 104598115 | 10459811 | 16 | Prophylaxis |
| 104598115 | 10459811 | 17 | Infection prophylaxis |
| 104598115 | 10459811 | 18 | Prophylaxis against graft versus host disease |
| 104598115 | 10459811 | 19 | Prophylaxis |
| 104598115 | 10459811 | 20 | Acute myeloid leukaemia |
| 104598115 | 10459811 | 21 | Hypothyroidism |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 104598115 | 10459811 | DE |
| 104598115 | 10459811 | HO |
| 104598115 | 10459811 | OT |
| 104598115 | 10459811 | LT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 104598115 | 10459811 | Adenovirus infection | |
| 104598115 | 10459811 | Anaemia | |
| 104598115 | 10459811 | Asphyxia | |
| 104598115 | 10459811 | BK virus infection | |
| 104598115 | 10459811 | Bacteraemia | |
| 104598115 | 10459811 | Diarrhoea haemorrhagic | |
| 104598115 | 10459811 | Enterococcal bacteraemia | |
| 104598115 | 10459811 | Enterococcal sepsis | |
| 104598115 | 10459811 | Gastric mucosal lesion | |
| 104598115 | 10459811 | Hepatic function abnormal | |
| 104598115 | 10459811 | Hypertension | |
| 104598115 | 10459811 | Inflammation | |
| 104598115 | 10459811 | Platelet count decreased | |
| 104598115 | 10459811 | Pneumonia | |
| 104598115 | 10459811 | Pyrexia | |
| 104598115 | 10459811 | Renal failure | |
| 104598115 | 10459811 | Respiratory failure | |
| 104598115 | 10459811 | Sepsis | |
| 104598115 | 10459811 | Thrombotic microangiopathy | |
| 104598115 | 10459811 | Venoocclusive liver disease |
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 |
|---|---|---|---|---|---|---|
| 104598115 | 10459811 | 1 | 20130907 | 20130907 | 0 | |
| 104598115 | 10459811 | 2 | 20130907 | 20130907 | 0 | |
| 104598115 | 10459811 | 3 | 20131203 | 20131204 | 0 | |
| 104598115 | 10459811 | 4 | 20130903 | 20130906 | 0 | |
| 104598115 | 10459811 | 5 | 20130907 | 20130907 | 0 | |
| 104598115 | 10459811 | 6 | 20130908 | 20131008 | 0 | |
| 104598115 | 10459811 | 7 | 20130908 | 20131008 | 0 | |
| 104598115 | 10459811 | 8 | 20130916 | 20130930 | 0 | |
| 104598115 | 10459811 | 9 | 20131028 | 20131215 | 0 | |
| 104598115 | 10459811 | 10 | 20130909 | 20131215 | 0 | |
| 104598115 | 10459811 | 11 | 20130830 | 20130902 | 0 | |
| 104598115 | 10459811 | 12 | 20130917 | 20131106 | 0 | |
| 104598115 | 10459811 | 13 | 20130907 | 20130915 | 0 | |
| 104598115 | 10459811 | 14 | 20130907 | 20130908 | 0 | |
| 104598115 | 10459811 | 15 | 20130907 | 20131103 | 0 | |
| 104598115 | 10459811 | 16 | 20130907 | 20131028 | 0 | |
| 104598115 | 10459811 | 17 | 20130908 | 20131208 | 0 | |
| 104598115 | 10459811 | 18 | 20130910 | 20130915 | 0 | |
| 104598115 | 10459811 | 19 | 20130910 | 20131215 | 0 | |
| 104598115 | 10459811 | 20 | 20131203 | 20131205 | 0 | |
| 104598115 | 10459811 | 21 | 20120608 | 20131215 | 0 |