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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127291511 | 12729151 | 1 | I | 20160830 | 20160909 | 20160909 | EXP | GB-JNJFOC-20160901486 | JANSSEN | CHISHOLM JC, MERKS JH, CASANOVA M, BISOGNO G, ORBACH D, GENTET J, ET AL. BERNIE: OPEN-LABEL, RANDOMIZED, PHASE II STUDY OF BEVACIZUMAB PLUS CHEMOTHERAPY IN PEDIATRIC METASTATIC RHABDOMYOSARCOMA (RMS) AND NON-RHABDOMYOSARCOMA SOFT TISSUE SARCOMA (NRSTS). JOURNAL OF CLINICAL ONCOLOGY 2016;34. | 0.00 | Y | 0.00000 | 20160909 | OT | GB | GB |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127291511 | 12729151 | 1 | SS | DOXORUBICIN HYDROCHLORIDE. | DOXORUBICIN HYDROCHLORIDE | 1 | Unknown | 4X21 DAY CYCLE | U | U | 0 | LIPOSOME INJECTION | |||||||
| 127291511 | 12729151 | 2 | PS | DOXORUBICIN HYDROCHLORIDE. | DOXORUBICIN HYDROCHLORIDE | 1 | Unknown | 4X21 DAY CYCLE | U | U | 50718 | LIPOSOME INJECTION | |||||||
| 127291511 | 12729151 | 3 | SS | BEVACIZUMAB | BEVACIZUMAB | 1 | Unknown | U | 0 | UNSPECIFIED | |||||||||
| 127291511 | 12729151 | 4 | SS | BEVACIZUMAB | BEVACIZUMAB | 1 | Unknown | U | 0 | UNSPECIFIED | |||||||||
| 127291511 | 12729151 | 5 | SS | IFOSFAMIDE. | IFOSFAMIDE | 1 | Unknown | 4X21 DAY CYCLES | U | 0 | UNSPECIFIED | ||||||||
| 127291511 | 12729151 | 6 | SS | IFOSFAMIDE. | IFOSFAMIDE | 1 | Unknown | 4X21 DAY CYCLES | U | 0 | UNSPECIFIED | ||||||||
| 127291511 | 12729151 | 7 | SS | VINCRISTINE | VINCRISTINE | 1 | Unknown | 4X21 DAY CYCLES | U | 0 | UNSPECIFIED | ||||||||
| 127291511 | 12729151 | 8 | SS | VINCRISTINE | VINCRISTINE | 1 | Unknown | 4X21 DAY CYCLES | U | 0 | UNSPECIFIED | ||||||||
| 127291511 | 12729151 | 9 | SS | ACTINOMYCIN D | DACTINOMYCIN | 1 | Unknown | 4X21 DAY CYCLES | U | 0 | UNSPECIFIED | ||||||||
| 127291511 | 12729151 | 10 | SS | ACTINOMYCIN D | DACTINOMYCIN | 1 | Unknown | 4X21 DAY CYCLES | U | 0 | UNSPECIFIED | ||||||||
| 127291511 | 12729151 | 11 | SS | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | Unknown | U | 0 | UNSPECIFIED | |||||||||
| 127291511 | 12729151 | 12 | SS | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | Unknown | U | 0 | UNSPECIFIED | |||||||||
| 127291511 | 12729151 | 13 | SS | VINORELBINE | VINORELBINEVINORELBINE TARTRATE | 1 | Unknown | U | 0 | UNSPECIFIED | |||||||||
| 127291511 | 12729151 | 14 | SS | VINORELBINE | VINORELBINEVINORELBINE TARTRATE | 1 | Unknown | U | 0 | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127291511 | 12729151 | 1 | Soft tissue sarcoma |
| 127291511 | 12729151 | 2 | Rhabdomyosarcoma |
| 127291511 | 12729151 | 3 | Rhabdomyosarcoma |
| 127291511 | 12729151 | 4 | Soft tissue sarcoma |
| 127291511 | 12729151 | 5 | Soft tissue sarcoma |
| 127291511 | 12729151 | 6 | Rhabdomyosarcoma |
| 127291511 | 12729151 | 7 | Rhabdomyosarcoma |
| 127291511 | 12729151 | 8 | Soft tissue sarcoma |
| 127291511 | 12729151 | 9 | Soft tissue sarcoma |
| 127291511 | 12729151 | 10 | Rhabdomyosarcoma |
| 127291511 | 12729151 | 11 | Rhabdomyosarcoma |
| 127291511 | 12729151 | 12 | Soft tissue sarcoma |
| 127291511 | 12729151 | 13 | Soft tissue sarcoma |
| 127291511 | 12729151 | 14 | Rhabdomyosarcoma |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127291511 | 12729151 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127291511 | 12729151 | Adverse event | |
| 127291511 | 12729151 | Off label use | |
| 127291511 | 12729151 | Product use issue |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |