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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125414012 | 12541401 | 2 | F | 20160627 | 20160713 | 20160708 | 20160720 | EXP | DE-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2016-BI-43951DE | BOEHRINGER INGELHEIM | 74.41 | YR | M | Y | 74.00000 | KG | 20160720 | MD | DE | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125414012 | 12541401 | 1 | PS | GILOTRIF | AFATINIB | 1 | Oral | 40 MG | N | 201292 | 40 | MG | TABLET | QD | |||||
| 125414012 | 12541401 | 2 | SS | GILOTRIF | AFATINIB | 1 | Oral | 30 MG | N | 201292 | 30 | MG | TABLET | QD | |||||
| 125414012 | 12541401 | 3 | SS | SPIRONOLACTON | SPIRONOLACTONE | 1 | Unknown | 1 ANZ | N | 0 | QD | ||||||||
| 125414012 | 12541401 | 4 | SS | METFORMIN | METFORMIN HYDROCHLORIDE | 1 | Unknown | 2 ANZ | N | 0 | BID | ||||||||
| 125414012 | 12541401 | 5 | C | ASPIRIN. | ASPIRIN | 1 | Unknown | 1 ANZ | 0 | QD | |||||||||
| 125414012 | 12541401 | 6 | C | VALSARTAN. | VALSARTAN | 1 | Unknown | 80 MG | 0 | 80 | MG | QD | |||||||
| 125414012 | 12541401 | 7 | C | NEBIVOLOL. | NEBIVOLOL | 1 | Unknown | 5 MG | 0 | 5 | MG | QD | |||||||
| 125414012 | 12541401 | 8 | C | TOREM | TORSEMIDE | 1 | Unknown | 2 ANZ | 0 | BID | |||||||||
| 125414012 | 12541401 | 9 | C | ALLOPURINOL. | ALLOPURINOL | 1 | Unknown | 1 ANZ | 0 | QD | |||||||||
| 125414012 | 12541401 | 10 | C | RANITIC | RANITIDINE HYDROCHLORIDE | 1 | Unknown | 300 MG | 0 | 150 | MG | BID | |||||||
| 125414012 | 12541401 | 11 | C | INEGY | EZETIMIBESIMVASTATIN | 1 | Unknown | 1 ANZ | 0 | QD | |||||||||
| 125414012 | 12541401 | 12 | C | ARCOXIA | ETORICOXIB | 1 | Unknown | STRENGTH: 60MG | 0 | ||||||||||
| 125414012 | 12541401 | 13 | C | BRIMICA GENUAIR | ACLIDINIUM BROMIDEFORMOTEROL FUMARATE | 1 | Unknown | 2 ANZ | 0 | BID | |||||||||
| 125414012 | 12541401 | 14 | C | LYRICA | PREGABALIN | 1 | Unknown | 1 ANZ | 0 | QD | |||||||||
| 125414012 | 12541401 | 15 | C | NOVAMINSULFON | METAMIZOLE | 1 | Unknown | 3 ANZ | 0 | TID | |||||||||
| 125414012 | 12541401 | 16 | C | NOVAMINSULFON | METAMIZOLE | 1 | 0 | ||||||||||||
| 125414012 | 12541401 | 17 | C | ZOMETA | ZOLEDRONIC ACID | 1 | Unknown | 4 MG | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125414012 | 12541401 | 1 | Lung adenocarcinoma |
| 125414012 | 12541401 | 2 | EGFR gene mutation |
| 125414012 | 12541401 | 3 | Product used for unknown indication |
| 125414012 | 12541401 | 4 | Type 2 diabetes mellitus |
| 125414012 | 12541401 | 5 | Coronary artery disease |
| 125414012 | 12541401 | 6 | Hypertension |
| 125414012 | 12541401 | 7 | Hypertension |
| 125414012 | 12541401 | 8 | Cardiac failure |
| 125414012 | 12541401 | 9 | Hyperuricaemia |
| 125414012 | 12541401 | 10 | Gastritis |
| 125414012 | 12541401 | 11 | Hyperlipidaemia |
| 125414012 | 12541401 | 12 | Product used for unknown indication |
| 125414012 | 12541401 | 13 | Chronic obstructive pulmonary disease |
| 125414012 | 12541401 | 14 | Diabetic neuropathy |
| 125414012 | 12541401 | 15 | Pain |
| 125414012 | 12541401 | 16 | Metastases to bone |
| 125414012 | 12541401 | 17 | Metastases to bone |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125414012 | 12541401 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125414012 | 12541401 | Blood creatine increased | |
| 125414012 | 12541401 | Dehydration | |
| 125414012 | 12541401 | Diarrhoea | |
| 125414012 | 12541401 | Renal failure | |
| 125414012 | 12541401 | Renal function test 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 |
|---|---|---|---|---|---|---|
| 125414012 | 12541401 | 1 | 20160301 | 20160702 | 0 | |
| 125414012 | 12541401 | 17 | 20160427 | 0 |