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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 115568356 | 11556835 | 6 | F | 20150911 | 20160919 | 20150925 | 20160923 | EXP | US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2015-BI-45949BI | BOEHRINGER INGELHEIM | 80.24 | YR | F | Y | 0.00000 | 20160923 | MD | COUNTRY NOT SPECIFIED | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 115568356 | 11556835 | 1 | PS | GILOTRIF | AFATINIB | 1 | Oral | 20 MG | Y | 201292 | 20 | MG | TABLET | QD | |||||
| 115568356 | 11556835 | 2 | SS | GILOTRIF | AFATINIB | 1 | Oral | 40 MG | Y | 201292 | 20 | MG | TABLET | BID | |||||
| 115568356 | 11556835 | 3 | SS | GILOTRIF | AFATINIB | 1 | Oral | 30 MG | Y | 201292 | 30 | MG | TABLET | QD | |||||
| 115568356 | 11556835 | 4 | SS | GILOTRIF | AFATINIB | 1 | Oral | 30 MG | Y | 201292 | 30 | MG | QD | ||||||
| 115568356 | 11556835 | 5 | SS | GILOTRIF | AFATINIB | 1 | Oral | 40 MG | Y | 201292 | 40 | MG | QD | ||||||
| 115568356 | 11556835 | 6 | SS | DEXAMETHASONE. | DEXAMETHASONE | 1 | Unknown | Y | 0 | TABLET | |||||||||
| 115568356 | 11556835 | 7 | SS | DEXAMETHASONE. | DEXAMETHASONE | 1 | Unknown | 0.5 ANZ | Y | 0 | TABLET | QD | |||||||
| 115568356 | 11556835 | 8 | C | METOPROLOL. | METOPROLOL | 1 | Unknown | 0 | |||||||||||
| 115568356 | 11556835 | 9 | C | LOSARTAN. | LOSARTAN | 1 | Unknown | 0 | |||||||||||
| 115568356 | 11556835 | 10 | C | HYDROCHLOROTHIAZIDE. | HYDROCHLOROTHIAZIDE | 1 | Unknown | 0 | |||||||||||
| 115568356 | 11556835 | 11 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | Unknown | 0 | |||||||||||
| 115568356 | 11556835 | 12 | C | ATORVASTATIN | ATORVASTATIN | 1 | Unknown | 0 | |||||||||||
| 115568356 | 11556835 | 13 | C | FENOFIBRATE. | FENOFIBRATE | 1 | Unknown | 0 | |||||||||||
| 115568356 | 11556835 | 14 | C | METFORMIN | METFORMIN HYDROCHLORIDE | 1 | Unknown | 0 | |||||||||||
| 115568356 | 11556835 | 15 | C | LEVETIRACETAM. | LEVETIRACETAM | 1 | Unknown | 0 | |||||||||||
| 115568356 | 11556835 | 16 | C | VITAMIN B12 | CYANOCOBALAMIN | 1 | Unknown | 0 | |||||||||||
| 115568356 | 11556835 | 17 | C | CALCIUM | CALCIUM | 1 | Unknown | 0 | |||||||||||
| 115568356 | 11556835 | 18 | C | CENTRUM | VITAMINS | 1 | Unknown | 0 | |||||||||||
| 115568356 | 11556835 | 19 | C | EUCERIN | ENSULIZOLEEUCERINOCTINOXATEOCTISALATETITANIUM DIOXIDEINC OXIDE | 1 | Unknown | 0 | |||||||||||
| 115568356 | 11556835 | 20 | C | LOPERAMIDE | LOPERAMIDE | 1 | Unknown | 0 | |||||||||||
| 115568356 | 11556835 | 21 | C | PRILOSEC | OMEPRAZOLE MAGNESIUM | 1 | Unknown | 0 | |||||||||||
| 115568356 | 11556835 | 22 | C | VITAMIN D | CHOLECALCIFEROL | 1 | Unknown | 0 | |||||||||||
| 115568356 | 11556835 | 23 | C | VITAMIN K2 | MENAQUINONE 6 | 1 | Unknown | 0 | |||||||||||
| 115568356 | 11556835 | 24 | C | HYDROCODONE | HYDROCODONE | 1 | Unknown | 0 | |||||||||||
| 115568356 | 11556835 | 25 | C | ZOLPIDEM TARTRATE. | ZOLPIDEM TARTRATE | 1 | Unknown | 0 | |||||||||||
| 115568356 | 11556835 | 26 | C | LEVOFLOXACIN. | LEVOFLOXACIN | 1 | Unknown | 0 | |||||||||||
| 115568356 | 11556835 | 27 | C | KLOR-CON | POTASSIUM CHLORIDE | 1 | Unknown | 0 | |||||||||||
| 115568356 | 11556835 | 28 | C | MAG OXIDE | MAGNESIUM OXIDE | 1 | Unknown | 0 | |||||||||||
| 115568356 | 11556835 | 29 | C | KEPPRA | LEVETIRACETAM | 1 | Unknown | 0 | |||||||||||
| 115568356 | 11556835 | 30 | C | ZOLPIDEM TARTRATE. | ZOLPIDEM TARTRATE | 1 | Unknown | 0 | |||||||||||
| 115568356 | 11556835 | 31 | C | AZELASTINE HCL | AZELASTINE HYDROCHLORIDE | 1 | Unknown | 0 | |||||||||||
| 115568356 | 11556835 | 32 | C | HYDROCODONE-ACETAMINOP | 2 | Unknown | 0 | ||||||||||||
| 115568356 | 11556835 | 33 | C | MOMETASONE FUROATE. | MOMETASONE FUROATE | 1 | Unknown | 0 | |||||||||||
| 115568356 | 11556835 | 34 | C | METOPROLOL SUCCINATE. | METOPROLOL SUCCINATE | 1 | Unknown | 0 | |||||||||||
| 115568356 | 11556835 | 35 | C | OXYCODONE HYDROCHLORIDE. | OXYCODONE HYDROCHLORIDE | 1 | Unknown | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 115568356 | 11556835 | 1 | Non-small cell lung cancer |
| 115568356 | 11556835 | 6 | Metastases to central nervous system |
| 115568356 | 11556835 | 8 | Hypertension |
| 115568356 | 11556835 | 9 | Hypertension |
| 115568356 | 11556835 | 10 | Hypertension |
| 115568356 | 11556835 | 11 | Barrett's oesophagus |
| 115568356 | 11556835 | 12 | Blood cholesterol increased |
| 115568356 | 11556835 | 13 | Blood cholesterol increased |
| 115568356 | 11556835 | 14 | Type 2 diabetes mellitus |
| 115568356 | 11556835 | 15 | Metastases to central nervous system |
| 115568356 | 11556835 | 16 | Product used for unknown indication |
| 115568356 | 11556835 | 17 | Product used for unknown indication |
| 115568356 | 11556835 | 18 | Product used for unknown indication |
| 115568356 | 11556835 | 19 | Product used for unknown indication |
| 115568356 | 11556835 | 20 | Product used for unknown indication |
| 115568356 | 11556835 | 21 | Product used for unknown indication |
| 115568356 | 11556835 | 22 | Product used for unknown indication |
| 115568356 | 11556835 | 23 | Product used for unknown indication |
| 115568356 | 11556835 | 24 | Product used for unknown indication |
| 115568356 | 11556835 | 25 | Product used for unknown indication |
| 115568356 | 11556835 | 26 | Product used for unknown indication |
| 115568356 | 11556835 | 27 | Product used for unknown indication |
| 115568356 | 11556835 | 28 | Product used for unknown indication |
| 115568356 | 11556835 | 29 | Product used for unknown indication |
| 115568356 | 11556835 | 30 | Product used for unknown indication |
| 115568356 | 11556835 | 31 | Product used for unknown indication |
| 115568356 | 11556835 | 32 | Product used for unknown indication |
| 115568356 | 11556835 | 33 | Product used for unknown indication |
| 115568356 | 11556835 | 34 | Product used for unknown indication |
| 115568356 | 11556835 | 35 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 115568356 | 11556835 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 115568356 | 11556835 | Alopecia | |
| 115568356 | 11556835 | Anal incontinence | |
| 115568356 | 11556835 | Asthenia | |
| 115568356 | 11556835 | Blood magnesium decreased | |
| 115568356 | 11556835 | Blood potassium decreased | |
| 115568356 | 11556835 | Constipation | |
| 115568356 | 11556835 | Cystitis | |
| 115568356 | 11556835 | Decreased appetite | |
| 115568356 | 11556835 | Dehydration | |
| 115568356 | 11556835 | Diarrhoea | |
| 115568356 | 11556835 | Drug ineffective | |
| 115568356 | 11556835 | Dry skin | |
| 115568356 | 11556835 | Dysgeusia | |
| 115568356 | 11556835 | Hallucination | |
| 115568356 | 11556835 | Hypotension | |
| 115568356 | 11556835 | Muscular weakness | |
| 115568356 | 11556835 | Nail bed inflammation | |
| 115568356 | 11556835 | Nail disorder | |
| 115568356 | 11556835 | Paronychia | |
| 115568356 | 11556835 | Peripheral swelling | |
| 115568356 | 11556835 | Rash | |
| 115568356 | 11556835 | Sinus disorder | |
| 115568356 | 11556835 | Skin abrasion | Skin abrasion |
| 115568356 | 11556835 | Sleep disorder | |
| 115568356 | 11556835 | Stomatitis | |
| 115568356 | 11556835 | Syncope | |
| 115568356 | 11556835 | Urine analysis 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 |
|---|---|---|---|---|---|---|
| 115568356 | 11556835 | 1 | 20150808 | 0 | ||
| 115568356 | 11556835 | 2 | 20150818 | 0 | ||
| 115568356 | 11556835 | 3 | 20150821 | 20150915 | 0 |