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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126870932 | 12687093 | 2 | F | 20160908 | 20160826 | 20160919 | EXP | DE-CIPLA LTD.-2016DE17530 | CIPLA | LATZ S, ELLINGER J, GOLTZ D, MARX C, LEUSCHNER I, M?LLER SC ET AL .,. SPINDLE CELL RHABDOMYOSARCOMA OF THE PROSTATE. INTERNATIONAL JOURNAL OF UROLOGY. 2013;20:935 TO 937 | 0.00 | Y | 0.00000 | 20160919 | OT | DE | DE |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126870932 | 12687093 | 1 | PS | TOPOTECAN | TOPOTECANTOPOTECAN HYDROCHLORIDE | 1 | Unknown | 8 MG, 1 CYCLE | U | U | 91199 | 8 | MG | ||||||
| 126870932 | 12687093 | 2 | SS | Vincristine | VINCRISTINE | 1 | Unknown | 1.5 MG/M2, 9 CYCLES | U | U | 0 | 1.5 | MG/M**2 | ||||||
| 126870932 | 12687093 | 3 | SS | Doxorubicin | DOXORUBICIN | 1 | Unknown | 2 ? 20 MG/M2, UNK | U | U | 0 | 20 | MG/M**2 | ||||||
| 126870932 | 12687093 | 4 | SS | IFOSFAMIDE. | IFOSFAMIDE | 1 | Unknown | 3000 MG/M2, 9 CYCLES | U | U | 0 | 3000 | MG/M**2 | ||||||
| 126870932 | 12687093 | 5 | SS | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | Unknown | 2000 MG, 1 CYCLE | U | U | 0 | 2000 | MG | ||||||
| 126870932 | 12687093 | 6 | SS | ACTINOMYCIN D | DACTINOMYCIN | 1 | Unknown | 1.5 MG/M2, 9 CYCLES | U | U | 0 | 1.5 | MG/M**2 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126870932 | 12687093 | 1 | Embryonal rhabdomyosarcoma |
| 126870932 | 12687093 | 2 | Rhabdomyosarcoma |
| 126870932 | 12687093 | 3 | Rhabdomyosarcoma |
| 126870932 | 12687093 | 4 | Embryonal rhabdomyosarcoma |
| 126870932 | 12687093 | 5 | Embryonal rhabdomyosarcoma |
| 126870932 | 12687093 | 6 | Embryonal rhabdomyosarcoma |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126870932 | 12687093 | DE |
| 126870932 | 12687093 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126870932 | 12687093 | Disease progression | |
| 126870932 | 12687093 | Ileus paralytic | |
| 126870932 | 12687093 | Metastases to peritoneum | |
| 126870932 | 12687093 | Neutropenia |
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 |
|---|---|---|---|---|---|---|
| 126870932 | 12687093 | 1 | 200911 | 0 | ||
| 126870932 | 12687093 | 2 | 200901 | 200909 | 0 | |
| 126870932 | 12687093 | 3 | 200901 | 200909 | 0 | |
| 126870932 | 12687093 | 4 | 200901 | 200909 | 0 | |
| 126870932 | 12687093 | 5 | 200911 | 0 | ||
| 126870932 | 12687093 | 6 | 200901 | 200909 | 0 |