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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127033861 | 12703386 | 1 | I | 20160824 | 20160831 | 20160831 | EXP | DE-JNJFOC-20160823160 | JANSSEN | FUCHS M, WONGSO D, PLUTSCHOW A, FEURING-BUSKE M, HERTENSTEIN B, HOFFKES HG, ET AL. FINAL ANALYSIS OF A RANDOMIZED PHASE II TRIAL WITH PREDNISONE, VINBLASTINE, DOXORUBICIN, AND GEMCITABINE IN PATIENTS WITH EARLY UNFAVORABLE HODGKIN LYMPHOMA-PVAG-14 PILOT-. ONCOLOGY RESEARCH AND TREATMENT 2014;37:11. | 0.00 | Y | 0.00000 | 20160831 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127033861 | 12703386 | 1 | PS | DOXORUBICIN HYDROCHLORIDE. | DOXORUBICIN HYDROCHLORIDE | 1 | Unknown | DOSE: 25 OR 35 MG/M2 | U | U | 50718 | LIPOSOME INJECTION | |||||||
| 127033861 | 12703386 | 2 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | U | 0 | UNSPECIFIED | |||||||||
| 127033861 | 12703386 | 3 | SS | VINBLASTINE | VINBLASTINE | 1 | Unknown | U | 0 | UNSPECIFIED | |||||||||
| 127033861 | 12703386 | 4 | SS | GEMCITABINE | GEMCITABINEGEMCITABINE HYDROCHLORIDE | 1 | Unknown | U | 0 | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127033861 | 12703386 | 1 | Hodgkin's disease |
| 127033861 | 12703386 | 2 | Hodgkin's disease |
| 127033861 | 12703386 | 3 | Hodgkin's disease |
| 127033861 | 12703386 | 4 | Hodgkin's disease |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127033861 | 12703386 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127033861 | 12703386 | Haematotoxicity | |
| 127033861 | 12703386 | Infection | |
| 127033861 | 12703386 | Leukopenia | |
| 127033861 | 12703386 | Off label use | |
| 127033861 | 12703386 | Product use issue | |
| 127033861 | 12703386 | Toxicity to various agents |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |