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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125659033 | 12565903 | 3 | F | 20110330 | 20160826 | 20160718 | 20160902 | EXP | DE-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2011-DE-02169DE | BOEHRINGER INGELHEIM | 59.75 | YR | F | Y | 69.00000 | KG | 20160902 | MD | COUNTRY NOT SPECIFIED | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125659033 | 12565903 | 1 | PS | BIBF 1120 | NINTEDANIB | 1 | Oral | 400 MG | Y | 205832 | 200 | MG | CAPSULE, SOFT | BID | |||||
| 125659033 | 12565903 | 2 | SS | BIBF 1120 | NINTEDANIB | 1 | Oral | 300 MG | Y | 205832 | 150 | MG | TABLET | BID | |||||
| 125659033 | 12565903 | 3 | SS | BIBF 1120 | NINTEDANIB | 1 | Oral | 300 MG | Y | 205832 | 150 | MG | TABLET | BID | |||||
| 125659033 | 12565903 | 4 | SS | CARBOPLATIN. | CARBOPLATIN | 1 | Intravenous (not otherwise specified) | U | 0 | SOLUTION FOR INJECTION/INFUSION | |||||||||
| 125659033 | 12565903 | 5 | SS | CARBOPLATIN. | CARBOPLATIN | 1 | Intravenous (not otherwise specified) | U | 0 | 616.8 | MG | SOLUTION FOR INJECTION/INFUSION | |||||||
| 125659033 | 12565903 | 6 | SS | CARBOPLATIN. | CARBOPLATIN | 1 | Intravenous (not otherwise specified) | STRENGTH: 555.30 | U | 0 | 555.3 | MG | SOLUTION FOR INJECTION/INFUSION | ||||||
| 125659033 | 12565903 | 7 | SS | PACLITAXEL. | PACLITAXEL | 1 | Intravenous (not otherwise specified) | Y | 0 | SOLUTION FOR INJECTION/INFUSION | |||||||||
| 125659033 | 12565903 | 8 | SS | PACLITAXEL. | PACLITAXEL | 1 | Intravenous (not otherwise specified) | Y | 0 | 309.75 | MG | SOLUTION FOR INJECTION/INFUSION | |||||||
| 125659033 | 12565903 | 9 | SS | PACLITAXEL. | PACLITAXEL | 1 | Intravenous (not otherwise specified) | Y | 0 | 309.75 | MG | SOLUTION FOR INJECTION/INFUSION | |||||||
| 125659033 | 12565903 | 10 | C | METOCLOPRAMIDE. | METOCLOPRAMIDE | 1 | Oral | PRN | 0 | 30 | MG | TABLET | |||||||
| 125659033 | 12565903 | 11 | C | DIOVAN | VALSARTAN | 1 | Oral | 40 MG | 0 | 40 | MG | TABLET | QD | ||||||
| 125659033 | 12565903 | 12 | C | DILZEM | DILTIAZEM | 1 | Oral | 90 MG | 0 | 90 | MG | TABLET | QD | ||||||
| 125659033 | 12565903 | 13 | C | DIURSAN | 2 | Oral | 50 MG | 0 | 50 | MG | TABLET | QD | |||||||
| 125659033 | 12565903 | 14 | C | EFEROX | LEVOTHYROXINE SODIUM | 1 | Oral | 125 MCG | 0 | 125 | UG | TABLET | |||||||
| 125659033 | 12565903 | 15 | C | VIGANTOLETTEN | CHOLECALCIFEROL | 1 | Oral | 1000 U | 0 | 1000 | IU | TABLET | |||||||
| 125659033 | 12565903 | 16 | C | DEXAMETHASONE. | DEXAMETHASONE | 1 | Oral | 8 MG | 0 | 8 | MG | TABLET | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125659033 | 12565903 | 1 | Ovarian cancer |
| 125659033 | 12565903 | 4 | Ovarian cancer |
| 125659033 | 12565903 | 7 | Ovarian cancer |
| 125659033 | 12565903 | 10 | Antiemetic supportive care |
| 125659033 | 12565903 | 11 | Hypertension |
| 125659033 | 12565903 | 12 | Hypertension |
| 125659033 | 12565903 | 13 | Hypertension |
| 125659033 | 12565903 | 14 | Thyroidectomy |
| 125659033 | 12565903 | 15 | Osteoporosis prophylaxis |
| 125659033 | 12565903 | 16 | Antiemetic supportive care |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125659033 | 12565903 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125659033 | 12565903 | Clostridium difficile colitis | |
| 125659033 | 12565903 | Diarrhoea | |
| 125659033 | 12565903 | Dizziness | |
| 125659033 | 12565903 | Nausea | |
| 125659033 | 12565903 | Vomiting |
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 |
|---|---|---|---|---|---|---|
| 125659033 | 12565903 | 1 | 20110329 | 20110427 | 0 | |
| 125659033 | 12565903 | 2 | 20110428 | 0 | ||
| 125659033 | 12565903 | 3 | 20110511 | 20110512 | 0 | |
| 125659033 | 12565903 | 4 | 20110328 | 20110328 | 0 | |
| 125659033 | 12565903 | 5 | 20110419 | 0 | ||
| 125659033 | 12565903 | 6 | 20110510 | 20110510 | 0 | |
| 125659033 | 12565903 | 7 | 20110328 | 20110328 | 0 | |
| 125659033 | 12565903 | 8 | 20110419 | 0 | ||
| 125659033 | 12565903 | 9 | 20110510 | 20110510 | 0 | |
| 125659033 | 12565903 | 10 | 20110328 | 0 | ||
| 125659033 | 12565903 | 11 | 1999 | 0 | ||
| 125659033 | 12565903 | 12 | 1999 | 0 | ||
| 125659033 | 12565903 | 13 | 1999 | 0 | ||
| 125659033 | 12565903 | 14 | 1989 | 0 | ||
| 125659033 | 12565903 | 15 | 2003 | 0 | ||
| 125659033 | 12565903 | 16 | 20110421 | 20110423 | 0 |