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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 109020506 | 10902050 | 6 | F | 20141205 | 20160718 | 20150310 | 20160722 | EXP | FR-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2015-BI-06217II | BOEHRINGER INGELHEIM | 67.18 | YR | F | Y | 50.00000 | KG | 20160722 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 109020506 | 10902050 | 1 | PS | BIBW 2992 | AFATINIB | 1 | Oral | 40 MG | Y | 201292 | 40 | MG | TABLET | QD | |||||
| 109020506 | 10902050 | 2 | SS | CETUXIMAB | CETUXIMAB | 1 | Intravenous (not otherwise specified) | 740 MG | Y | 0 | 740 | MG | SOLUTION FOR INJECTION/INFUSION | QD | |||||
| 109020506 | 10902050 | 3 | C | LOXEN | NICARDIPINE HYDROCHLORIDE | 1 | Oral | 0 | |||||||||||
| 109020506 | 10902050 | 4 | C | LOXEN | NICARDIPINE HYDROCHLORIDE | 1 | Oral | DOSE PER APPLICATION: 50 | 0 | ||||||||||
| 109020506 | 10902050 | 5 | C | IRBESARTAN. | IRBESARTAN | 1 | Oral | 0 | |||||||||||
| 109020506 | 10902050 | 6 | C | IRBESARTAN. | IRBESARTAN | 1 | Oral | DOSE PER APPLICATION: 150 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 109020506 | 10902050 | 1 | Colorectal cancer metastatic |
| 109020506 | 10902050 | 2 | Colorectal cancer metastatic |
| 109020506 | 10902050 | 3 | Hypertension |
| 109020506 | 10902050 | 5 | Hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 109020506 | 10902050 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 109020506 | 10902050 | Asthenia | |
| 109020506 | 10902050 | Dermatitis acneiform | |
| 109020506 | 10902050 | Gamma-glutamyltransferase |
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 |
|---|---|---|---|---|---|---|
| 109020506 | 10902050 | 1 | 20141202 | 20141212 | 0 | |
| 109020506 | 10902050 | 2 | 20141202 | 20141202 | 0 | |
| 109020506 | 10902050 | 3 | 201405 | 0 | ||
| 109020506 | 10902050 | 4 | 20141125 | 0 | ||
| 109020506 | 10902050 | 5 | 201405 | 0 | ||
| 109020506 | 10902050 | 6 | 20141125 | 0 |