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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125053152 | 12505315 | 2 | F | 20160404 | 20160712 | 20160628 | 20160719 | EXP | PHHY2016FR086435 | NOVARTIS | 37.00 | YR | F | Y | 54.00000 | KG | 20160719 | CN | COUNTRY NOT SPECIFIED | FR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125053152 | 12505315 | 1 | PS | ZOLEDRONATE | ZOLEDRONIC ACID | 1 | Intravenous (not otherwise specified) | 4 MG, UNK (1 CYCLE PERFORMED) | 21223 | 4 | MG | ||||||||
| 125053152 | 12505315 | 2 | SS | SIROLIMUS. | SIROLIMUS | 1 | Oral | 4 MG, UNK (1 CYCLE PERFORMED) | Y | 0 | 4 | MG | |||||||
| 125053152 | 12505315 | 3 | SS | METHOTREXATE SODIUM. | METHOTREXATE SODIUM | 1 | Oral | 5 MG, UNK (1 CYCLE PERFORMED) | Y | 0 | 5 | MG | |||||||
| 125053152 | 12505315 | 4 | SS | ENDOXAN | CYCLOPHOSPHAMIDE | 1 | Oral | 50 MG, UNK | Y | 0 | 50 | MG | |||||||
| 125053152 | 12505315 | 5 | C | TOPALGIC//TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | 1 | Unknown | UNK | 0 | ||||||||||
| 125053152 | 12505315 | 6 | C | VOGALENE | METOPIMAZINE | 1 | Unknown | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125053152 | 12505315 | 1 | Product used for unknown indication |
| 125053152 | 12505315 | 2 | Product used for unknown indication |
| 125053152 | 12505315 | 3 | Product used for unknown indication |
| 125053152 | 12505315 | 4 | Product used for unknown indication |
| 125053152 | 12505315 | 5 | Tumour pain |
| 125053152 | 12505315 | 6 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125053152 | 12505315 | HO |
| 125053152 | 12505315 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125053152 | 12505315 | Gamma-glutamyltransferase increased | |
| 125053152 | 12505315 | Hepatocellular injury | |
| 125053152 | 12505315 | Lymphopenia | |
| 125053152 | 12505315 | Metastases to liver | |
| 125053152 | 12505315 | Pleural effusion |
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 |
|---|---|---|---|---|---|---|
| 125053152 | 12505315 | 1 | 20160319 | 20160319 | 0 | |
| 125053152 | 12505315 | 2 | 20160318 | 20160411 | 0 | |
| 125053152 | 12505315 | 3 | 20160318 | 20160411 | 0 | |
| 125053152 | 12505315 | 4 | 20160318 | 20160408 | 0 | |
| 125053152 | 12505315 | 5 | 20160324 | 0 | ||
| 125053152 | 12505315 | 6 | 20160321 | 0 |