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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127844431 | 12784443 | 1 | I | 20160920 | 20160927 | 20160927 | EXP | CN-SA-2016SA178321 | AVENTIS | WANG J, WANG Y, WU L, ZHANG J, LAI W AND WANG Z. PEG-ASPARGASE AND DEP REGIMEN COMBINATION THERAPY FOR REFRACTORY EPSTEIN-BARR VIRUS-ASSOCIATED HEMOPHAGOCYTIC LYMPHOHISTIOCYTOSIS. JOURNAL OF HEMATOLOGY + ONCOLOGY. (2016) 9:84. DOI 10.1186/S13045-016-0317-7. | 0.00 | A | Y | 0.00000 | 20160927 | OT | CN | CN |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127844431 | 12784443 | 1 | PS | ANTI-THYMOCYTE GLOBULIN (RABBIT) | LAPINE T-LYMPHOCYTE IMMUNE GLOBULIN | 1 | Unknown | DOSE: | U | UNKNOWN | 103869 | 3 | MG/KG | ||||||
| 127844431 | 12784443 | 2 | SS | METHOTREXATE. | METHOTREXATE | 1 | Unknown | U | UNKNOWN | 0 | 15 | MG/M**2 | QD | ||||||
| 127844431 | 12784443 | 3 | SS | METHOTREXATE. | METHOTREXATE | 1 | Unknown | U | UNKNOWN | 0 | 10 | MG/M**2 | QD | ||||||
| 127844431 | 12784443 | 4 | SS | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Unknown | 15 MG/KG/DAY FOR DAYS 1 TO 3, 0.75 MG/KG/DAY FOR DAYS 4 TO 7, AND 0.25 MG/KG/DAY FOR DAYS 8 TO 10 | U | UNKNOWN | 0 | QD | |||||||
| 127844431 | 12784443 | 5 | SS | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Unknown | 15 MG/KG/DAY FOR DAYS 1 TO 3, 0.75 MG/KG/DAY FOR DAYS 4 TO 7, AND 0.25 MG/KG/DAY FOR DAYS 8 TO 10 | U | UNKNOWN | 0 | QD | |||||||
| 127844431 | 12784443 | 6 | SS | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | Unknown | DOSE:1.8 GRAM(S)/SQUARE METER | U | UNKNOWN | 0 | QD | |||||||
| 127844431 | 12784443 | 7 | SS | PEGASPARGASE | PEGASPARGASE | 1 | Unknown | DOSE: 2000 U/M2 | U | UNKNOWN | 0 | ||||||||
| 127844431 | 12784443 | 8 | SS | PEGASPARGASE | PEGASPARGASE | 1 | Unknown | DOSE: 2000 U/M2 | U | UNKNOWN | 0 | ||||||||
| 127844431 | 12784443 | 9 | SS | ETOPOSIDE. | ETOPOSIDE | 1 | Unknown | U | UNKNOWN | 0 | 100 | MG/M**2 | /wk | ||||||
| 127844431 | 12784443 | 10 | SS | ETOPOSIDE. | ETOPOSIDE | 1 | Unknown | U | UNKNOWN | 0 | 100 | MG/M**2 | /wk | ||||||
| 127844431 | 12784443 | 11 | SS | ETOPOSIDE. | ETOPOSIDE | 1 | Unknown | U | UNKNOWN | 0 | 100 | MG/M**2 | /wk | ||||||
| 127844431 | 12784443 | 12 | SS | ETOPOSIDE. | ETOPOSIDE | 1 | Unknown | U | UNKNOWN | 0 | 5 | MG/KG | QD | ||||||
| 127844431 | 12784443 | 13 | SS | ETOPOSIDE. | ETOPOSIDE | 1 | Unknown | U | UNKNOWN | 0 | 5 | MG/KG | QD | ||||||
| 127844431 | 12784443 | 14 | SS | ETOPOSIDE. | ETOPOSIDE | 1 | Unknown | U | UNKNOWN | 0 | 5 | MG/KG | QD | ||||||
| 127844431 | 12784443 | 15 | SS | CYCLOSPORIN A | CYCLOSPORINE | 1 | Intravenous (not otherwise specified) | U | UNKNOWN | 0 | 3 | MG/KG | QD | ||||||
| 127844431 | 12784443 | 16 | SS | DOXORUBICIN HYDROCHLORIDE. | DOXORUBICIN HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | U | UNKNOWN | 0 | 25 | MG/M**2 | INJECTION | QD | |||||
| 127844431 | 12784443 | 17 | SS | DOXORUBICIN HYDROCHLORIDE. | DOXORUBICIN HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | U | UNKNOWN | 0 | 25 | MG/M**2 | INJECTION | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127844431 | 12784443 | 1 | Prophylaxis against graft versus host disease |
| 127844431 | 12784443 | 2 | Prophylaxis against graft versus host disease |
| 127844431 | 12784443 | 3 | Prophylaxis against graft versus host disease |
| 127844431 | 12784443 | 4 | Epstein-Barr virus infection |
| 127844431 | 12784443 | 5 | Histiocytosis haematophagic |
| 127844431 | 12784443 | 6 | Stem cell transplant |
| 127844431 | 12784443 | 7 | Epstein-Barr virus infection |
| 127844431 | 12784443 | 8 | Histiocytosis haematophagic |
| 127844431 | 12784443 | 9 | Epstein-Barr virus infection |
| 127844431 | 12784443 | 10 | Histiocytosis haematophagic |
| 127844431 | 12784443 | 11 | Stem cell transplant |
| 127844431 | 12784443 | 12 | Epstein-Barr virus infection |
| 127844431 | 12784443 | 13 | Histiocytosis haematophagic |
| 127844431 | 12784443 | 14 | Stem cell transplant |
| 127844431 | 12784443 | 15 | Prophylaxis against graft versus host disease |
| 127844431 | 12784443 | 16 | Epstein-Barr virus infection |
| 127844431 | 12784443 | 17 | Histiocytosis haematophagic |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127844431 | 12784443 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127844431 | 12784443 | Gastrointestinal haemorrhage | |
| 127844431 | 12784443 | Graft versus host disease |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |