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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127111472 | 12711147 | 2 | F | 20160426 | 20160912 | 20160902 | 20160922 | PER | US-JNJFOC-20160811232 | JANSSEN | 61.30 | YR | A | M | Y | 111.59000 | KG | 20160922 | OT | US | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127111472 | 12711147 | 1 | SS | INVOKAMET | CANAGLIFLOZINMETFORMIN HYDROCHLORIDE | 1 | Oral | Y | U | UNKNOWN;UNKNOWN | 0 | TABLET | |||||||
| 127111472 | 12711147 | 2 | PS | INVOKAMET | CANAGLIFLOZINMETFORMIN HYDROCHLORIDE | 1 | Oral | 50/1000MG WITH MEALS | Y | U | UNKNOWN;UNKNOWN | 204353 | TABLET | ||||||
| 127111472 | 12711147 | 3 | SS | BENAZEPRIL HYDROCHLORIDE. | BENAZEPRIL HYDROCHLORIDE | 1 | Oral | D | 0 | 5 | MG | TABLET | |||||||
| 127111472 | 12711147 | 4 | SS | BENAZEPRIL HYDROCHLORIDE. | BENAZEPRIL HYDROCHLORIDE | 1 | Oral | D | 0 | 20 | MG | TABLET | QD | ||||||
| 127111472 | 12711147 | 5 | C | FUROSEMIDE. | FUROSEMIDE | 1 | Oral | D | 0 | 20 | MG | TABLET | QD | ||||||
| 127111472 | 12711147 | 6 | C | AMLODIPINE BESYLATE. | AMLODIPINE BESYLATE | 1 | Oral | D | 0 | 5 | MG | TABLET | QD | ||||||
| 127111472 | 12711147 | 7 | C | METOPROLOL SUCCINATE. | METOPROLOL SUCCINATE | 1 | Oral | EXTENDED RELEASE 24 HOUR | D | 0 | 100 | MG | TABLET | BID | |||||
| 127111472 | 12711147 | 8 | C | BUPROPION HCL ER | BUPROPION HYDROCHLORIDE | 1 | Oral | EXTENDED RELEASE 12 HOUR | D | 0 | 150 | MG | TABLET | QD | |||||
| 127111472 | 12711147 | 9 | C | NIACIN. | NIACIN | 1 | Oral | EXTENDED RELEASE | D | 0 | 1000 | MG | TABLET | BID | |||||
| 127111472 | 12711147 | 10 | C | INSULIN | INSULIN NOS | 1 | Subcutaneous | 31GX 5/16 MISCELLANEOUS | D | 0 | INJECTION | ||||||||
| 127111472 | 12711147 | 11 | C | HUMULIN R | INSULIN HUMAN | 1 | Subcutaneous | U-500 (CONCENTRATED) 500 UNITS/ML SOLUTON, INJECT 25 UNITS AC BREAKFAST, 15 UNITS AT NIGHT | D | 0 | INJECTION | ||||||||
| 127111472 | 12711147 | 12 | C | ASA | ASPIRIN | 1 | Oral | ADULT ASPIRIN, LOW DOSE; DELAYED RELEASE | D | 0 | 81 | MG | TABLET | QD | |||||
| 127111472 | 12711147 | 13 | C | FENOFIBRATE. | FENOFIBRATE | 1 | Oral | 1 TABLET EVERY NIGHT | D | 0 | 145 | MG | TABLET | QD | |||||
| 127111472 | 12711147 | 14 | C | AMITRIPTYLINE HCL | AMITRIPTYLINE | 1 | Unknown | AT BEDTIME | D | 0 | 25 | MG | TABLET | QD | |||||
| 127111472 | 12711147 | 15 | C | METFORMIN HYDROCHLORIDE. | METFORMIN HYDROCHLORIDE | 1 | Unknown | D | 0 | 1000 | MG | TABLET | QD | ||||||
| 127111472 | 12711147 | 16 | C | METFORMIN HYDROCHLORIDE. | METFORMIN HYDROCHLORIDE | 1 | Unknown | D | 0 | 1000 | MG | TABLET | BID | ||||||
| 127111472 | 12711147 | 17 | C | HYDROCODONE/ACETAMINOPHEN | ACETAMINOPHENHYDROCODONE | 1 | Unknown | 5-325 MG, 1 TABLET AS NEEDED EVERY 8 HOURS | D | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127111472 | 12711147 | 1 | Diabetes mellitus |
| 127111472 | 12711147 | 2 | Diabetes mellitus |
| 127111472 | 12711147 | 3 | Product used for unknown indication |
| 127111472 | 12711147 | 4 | Product used for unknown indication |
| 127111472 | 12711147 | 7 | Blood pressure measurement |
| 127111472 | 12711147 | 8 | Smoking cessation therapy |
| 127111472 | 12711147 | 9 | Hyperlipidaemia |
| 127111472 | 12711147 | 10 | Diabetes mellitus |
| 127111472 | 12711147 | 11 | Diabetes mellitus |
| 127111472 | 12711147 | 12 | Cardiac disorder |
| 127111472 | 12711147 | 13 | Hyperlipidaemia |
| 127111472 | 12711147 | 17 | Pain |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127111472 | 12711147 | Blood creatinine increased | |
| 127111472 | 12711147 | Blood glucose increased | |
| 127111472 | 12711147 | Blood potassium increased | |
| 127111472 | 12711147 | Blood urea increased | |
| 127111472 | 12711147 | Drug prescribing error | |
| 127111472 | 12711147 | Hypoglycaemia | |
| 127111472 | 12711147 | Insomnia | |
| 127111472 | 12711147 | Lethargy | |
| 127111472 | 12711147 | Microalbuminuria | |
| 127111472 | 12711147 | Off label use |
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 |
|---|---|---|---|---|---|---|
| 127111472 | 12711147 | 2 | 20160429 | 0 |