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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127041811 | 12704181 | 1 | I | 20160822 | 20160831 | 20160831 | EXP | JP-MYLANLABS-2016M1035581 | MYLAN | NAKAGAWA N, HASHII Y, MATSUMURA R, YOSHIDA H, MIYASHITA E, MIYAMURA T, OZONO K.. HEMATOPOIETIC STEM CELL TRANSPLANTATION IN TWO CASES OF SECONDARY ACUTE MYELOID LEUKEMIA AFTER TREATMENT OF RHABDOMYOSARCOMA.. JAPANESE JOURNAL OF PEDIATRIC HEMATOLOGY/ONCOLOGY. 2016;53(2):123-128 | 0.00 | Y | 0.00000 | 20160831 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127041811 | 12704181 | 1 | PS | CARBOPLATIN. | CARBOPLATIN | 1 | Intravenous drip | 300 MG, QD | U | U | 91063 | 300 | MG | INJECTION | QD | ||||
| 127041811 | 12704181 | 2 | SS | CISPLATIN. | CISPLATIN | 1 | Intravenous drip | 400 MG/M2, QD | U | U | 0 | 400 | MG/M**2 | INJECTION | QD | ||||
| 127041811 | 12704181 | 3 | SS | CISPLATIN. | CISPLATIN | 1 | Intravenous drip | 100 MG/M2, QD | U | U | 0 | 100 | MG/M**2 | INJECTION | QD | ||||
| 127041811 | 12704181 | 4 | SS | ETOPOSIDE. | ETOPOSIDE | 1 | Intravenous drip | 3000 MG/M2, QD | U | U | 0 | 3000 | MG/M**2 | INJECTION | QD | ||||
| 127041811 | 12704181 | 5 | SS | IFOSFAMIDE. | IFOSFAMIDE | 1 | Intravenous drip | 27 ??, ?? | U | U | 0 | INJECTION | |||||||
| 127041811 | 12704181 | 6 | SS | TOPOTECAN | TOPOTECANTOPOTECAN HYDROCHLORIDE | 1 | Intravenous drip | 25 MG/M2, QD | U | U | 0 | 25 | MG/M**2 | INJECTION | QD | ||||
| 127041811 | 12704181 | 7 | SS | TOPOTECAN | TOPOTECANTOPOTECAN HYDROCHLORIDE | 1 | Intravenous drip | 37.5 MG/M2, QD | U | U | 0 | 37.5 | MG/M**2 | INJECTION | QD | ||||
| 127041811 | 12704181 | 8 | SS | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | Intravenous drip | 6000G/M2 | U | U | 0 | INJECTION | |||||||
| 127041811 | 12704181 | 9 | SS | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | Intravenous drip | 6000 ??, ?? | U | U | 0 | INJECTION | |||||||
| 127041811 | 12704181 | 10 | SS | PIRARUBICIN | PIRARUBICIN | 1 | Intravenous drip | 180 MG/M2, QD | U | U | 0 | 180 | MG/M**2 | INJECTION | QD | ||||
| 127041811 | 12704181 | 11 | SS | VINCRISTINE SULFATE. | VINCRISTINE SULFATE | 1 | Intravenous drip | 13.5 MG/M2, QD | U | U | 0 | 13.5 | MG/M**2 | INJECTION | QD | ||||
| 127041811 | 12704181 | 12 | SS | VINCRISTINE SULFATE. | VINCRISTINE SULFATE | 1 | Intravenous drip | 1.5 MG/M2, QD | U | U | 0 | 1.5 | MG/M**2 | INJECTION | QD | ||||
| 127041811 | 12704181 | 13 | SS | DACTINOMYCIN | DACTINOMYCIN | 1 | Intravenous drip | 0.195 MG/M2, QD | U | U | 0 | .195 | MG/M**2 | INJECTION | QD | ||||
| 127041811 | 12704181 | 14 | SS | DACTINOMYCIN | DACTINOMYCIN | 1 | Intravenous drip | 0.315 MG/M2, QD | U | U | 0 | .315 | MG/M**2 | INJECTION | QD | ||||
| 127041811 | 12704181 | 15 | SS | IRINOTECAN | IRINOTECAN | 1 | Intravenous drip | 1750 MG/M2, QD | U | U | 0 | 1750 | MG/M**2 | INFUSION | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127041811 | 12704181 | 1 | Embryonal rhabdomyosarcoma |
| 127041811 | 12704181 | 2 | Embryonal rhabdomyosarcoma |
| 127041811 | 12704181 | 4 | Embryonal rhabdomyosarcoma |
| 127041811 | 12704181 | 5 | Embryonal rhabdomyosarcoma |
| 127041811 | 12704181 | 6 | Embryonal rhabdomyosarcoma |
| 127041811 | 12704181 | 8 | Embryonal rhabdomyosarcoma |
| 127041811 | 12704181 | 10 | Embryonal rhabdomyosarcoma |
| 127041811 | 12704181 | 11 | Embryonal rhabdomyosarcoma |
| 127041811 | 12704181 | 13 | Embryonal rhabdomyosarcoma |
| 127041811 | 12704181 | 15 | Embryonal rhabdomyosarcoma |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127041811 | 12704181 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127041811 | 12704181 | Cytomegalovirus infection | |
| 127041811 | 12704181 | Graft versus host disease | |
| 127041811 | 12704181 | Hepatic function abnormal | |
| 127041811 | 12704181 | 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 |
|---|---|---|---|---|---|---|
| 127041811 | 12704181 | 1 | 2008 | 0 | ||
| 127041811 | 12704181 | 2 | 2008 | 0 | ||
| 127041811 | 12704181 | 4 | 2008 | 0 | ||
| 127041811 | 12704181 | 5 | 2008 | 0 | ||
| 127041811 | 12704181 | 6 | 2008 | 0 | ||
| 127041811 | 12704181 | 8 | 2008 | 0 | ||
| 127041811 | 12704181 | 10 | 2008 | 0 | ||
| 127041811 | 12704181 | 11 | 2008 | 0 | ||
| 127041811 | 12704181 | 14 | 2008 | 0 | ||
| 127041811 | 12704181 | 15 | 2008 | 0 |