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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125422361 | 12542236 | 1 | I | 20100607 | 20100609 | 20160708 | 20160708 | EXP | IT-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2010-IT-00129IT | BOEHRINGER INGELHEIM | 69.94 | YR | F | Y | 94.00000 | KG | 20160709 | MD | COUNTRY NOT SPECIFIED | IT |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125422361 | 12542236 | 1 | PS | BIBF 1120 | NINTEDANIB | 1 | Oral | 400 MG | Y | 71005 | 100 | MG | CAPSULE, SOFT | ||||||
| 125422361 | 12542236 | 2 | SS | CARBOPLATIN. | CARBOPLATIN | 1 | Intravenous (not otherwise specified) | 695 MG | Y | 0 | 450 | MG | SOLUTION FOR INJECTION/INFUSION | ||||||
| 125422361 | 12542236 | 3 | SS | PACLITAXEL. | PACLITAXEL | 1 | Intravenous (not otherwise specified) | 335 MG | Y | 0 | 300 | MG | SOLUTION FOR INJECTION/INFUSION | ||||||
| 125422361 | 12542236 | 4 | C | NORVASC | AMLODIPINE BESYLATE | 1 | Oral | 10 MG | 0 | 10 | MG | TABLET | QD | ||||||
| 125422361 | 12542236 | 5 | C | TENORIM | 2 | Oral | 100 MG | 0 | 100 | MG | TABLET | QD | |||||||
| 125422361 | 12542236 | 6 | C | COTAREG | HYDROCHLOROTHIAZIDEVALSARTAN | 1 | Oral | 80/ 12.5 MG | 0 | TABLET | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125422361 | 12542236 | 1 | Ovarian cancer |
| 125422361 | 12542236 | 2 | Ovarian cancer |
| 125422361 | 12542236 | 3 | Ovarian cancer |
| 125422361 | 12542236 | 4 | Hypertension |
| 125422361 | 12542236 | 5 | Hypertension |
| 125422361 | 12542236 | 6 | Hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125422361 | 12542236 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125422361 | 12542236 | Ascites | |
| 125422361 | 12542236 | Asthenia | |
| 125422361 | 12542236 | Dyspnoea | |
| 125422361 | 12542236 | Intestinal perforation | |
| 125422361 | 12542236 | Mucosal inflammation | |
| 125422361 | 12542236 | Neutropenia | |
| 125422361 | 12542236 | Pneumonitis | |
| 125422361 | 12542236 | Proteinuria | |
| 125422361 | 12542236 | Thrombocytopenia |
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 |
|---|---|---|---|---|---|---|
| 125422361 | 12542236 | 1 | 20100420 | 20100607 | 0 | |
| 125422361 | 12542236 | 2 | 20100419 | 20100630 | 0 | |
| 125422361 | 12542236 | 3 | 20100419 | 20100630 | 0 |