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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125451622 | 12545162 | 2 | F | 20120705 | 20160708 | 20160711 | 20160720 | EXP | DE-ASTELLAS-2016US026376 | ASTELLAS | 71.00 | YR | M | Y | 0.00000 | 20160720 | CN | GB | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125451622 | 12545162 | 1 | PS | Erlotinib | ERLOTINIB | 1 | Oral | 2800 | MG | 21743 | 100 | MG | TABLET | QD | |||||
| 125451622 | 12545162 | 2 | SS | GEMCITABINE | GEMCITABINEGEMCITABINE HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | 2000 | MG/M2 | 0 | 1000 | MG/M**2 | FORMULATION UNKNOWN | /wk | |||||
| 125451622 | 12545162 | 3 | C | RAMIPRIL. | RAMIPRIL | 1 | Oral | U | 0 | 10 | MG | FORMULATION UNKNOWN | |||||||
| 125451622 | 12545162 | 4 | C | FLUVASTATIN | FLUVASTATIN SODIUM | 1 | Oral | U | 0 | 40 | MG | FORMULATION UNKNOWN | |||||||
| 125451622 | 12545162 | 5 | C | PANTOPRAZOL | PANTOPRAZOLE SODIUM | 1 | Oral | U | 0 | 40 | MG | FORMULATION UNKNOWN | |||||||
| 125451622 | 12545162 | 6 | C | MACROGOL | POLYETHYLENE GLYCOLS | 1 | Oral | U | 0 | 3350 | MG | FORMULATION UNKNOWN | |||||||
| 125451622 | 12545162 | 7 | C | AMITRIPTYLINE | AMITRIPTYLINE | 1 | Oral | U | 0 | 3350 | MG | FORMULATION UNKNOWN | |||||||
| 125451622 | 12545162 | 8 | C | FENTANYL. | FENTANYL | 1 | Oral | 125 MICRO M/H, THRICE DAILY | 0 | FORMULATION UNKNOWN | TID | ||||||||
| 125451622 | 12545162 | 9 | C | BUPRENORPHIN ACINO | 2 | Sublingual | 0.4 MG, AS NEEDED | U | 0 | .4 | MG | FORMULATION UNKNOWN | |||||||
| 125451622 | 12545162 | 10 | C | RALTEGRAVIR. | RALTEGRAVIR | 1 | Oral | U | 0 | 400 | MG | FORMULATION UNKNOWN | |||||||
| 125451622 | 12545162 | 11 | C | TENOFOVIR | TENOFOVIR | 1 | Oral | U | 0 | 245 | MG | FORMULATION UNKNOWN | |||||||
| 125451622 | 12545162 | 12 | C | LAMIVUDINE. | LAMIVUDINE | 1 | Oral | U | 0 | 300 | MG | FORMULATION UNKNOWN | |||||||
| 125451622 | 12545162 | 13 | C | SMOFKABIVEN | UNSPECIFIED INGREDIENT | 1 | Intravenous (not otherwise specified) | 1600 KCAL, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 125451622 | 12545162 | 14 | C | METOPROLOL. | METOPROLOL | 1 | Oral | 47.5 MG, DAY | U | 0 | 47.5 | MG | FORMULATION UNKNOWN |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125451622 | 12545162 | 1 | Neoplasm malignant |
| 125451622 | 12545162 | 2 | Neoplasm malignant |
| 125451622 | 12545162 | 3 | Hypertension |
| 125451622 | 12545162 | 4 | Product used for unknown indication |
| 125451622 | 12545162 | 5 | Prophylaxis |
| 125451622 | 12545162 | 6 | Constipation |
| 125451622 | 12545162 | 7 | Constipation |
| 125451622 | 12545162 | 8 | Pain |
| 125451622 | 12545162 | 9 | Pain |
| 125451622 | 12545162 | 10 | HIV infection |
| 125451622 | 12545162 | 11 | HIV infection |
| 125451622 | 12545162 | 12 | HIV infection |
| 125451622 | 12545162 | 13 | Prophylaxis |
| 125451622 | 12545162 | 14 | Hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125451622 | 12545162 | HO |
| 125451622 | 12545162 | OT |
| 125451622 | 12545162 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125451622 | 12545162 | Anaemia | |
| 125451622 | 12545162 | General physical health deterioration | |
| 125451622 | 12545162 | Malignant neoplasm progression | |
| 125451622 | 12545162 | Nausea | |
| 125451622 | 12545162 | Platelet count abnormal | |
| 125451622 | 12545162 | Rash | |
| 125451622 | 12545162 | White blood cell count abnormal |
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 |
|---|---|---|---|---|---|---|
| 125451622 | 12545162 | 1 | 20120705 | 20120801 | 0 | |
| 125451622 | 12545162 | 2 | 20120705 | 20120712 | 0 | |
| 125451622 | 12545162 | 3 | 20120705 | 20120923 | 0 | |
| 125451622 | 12545162 | 4 | 20120705 | 20120923 | 0 | |
| 125451622 | 12545162 | 5 | 20120705 | 20120923 | 0 | |
| 125451622 | 12545162 | 6 | 20120705 | 20120923 | 0 | |
| 125451622 | 12545162 | 7 | 20120705 | 20120923 | 0 | |
| 125451622 | 12545162 | 8 | 20120705 | 20120923 | 0 | |
| 125451622 | 12545162 | 9 | 20120705 | 20120923 | 0 | |
| 125451622 | 12545162 | 10 | 20120705 | 20120923 | 0 | |
| 125451622 | 12545162 | 11 | 20120705 | 20120923 | 0 | |
| 125451622 | 12545162 | 12 | 20120705 | 20120923 | 0 | |
| 125451622 | 12545162 | 13 | 20120816 | 20120923 | 0 | |
| 125451622 | 12545162 | 14 | 20120705 | 20120923 | 0 |