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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127175041 | 12717504 | 1 | I | 20151202 | 20160906 | 20160906 | PER | US-AMNEAL PHARMACEUTICALS-2015AMN00217 | AMNEAL | 0.00 | M | Y | 96.15000 | KG | 20160906 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127175041 | 12717504 | 1 | PS | GABAPENTIN. | GABAPENTIN | 1 | Oral | 300 MG, 3X/DAY | AR150944 | 78428 | 300 | MG | CAPSULE | TID | |||||
| 127175041 | 12717504 | 2 | C | LANTUS | INSULIN GLARGINE | 1 | Subcutaneous | UNK | 0 | ||||||||||
| 127175041 | 12717504 | 3 | C | HUMALOG | INSULIN LISPRO | 1 | Subcutaneous | 10 MG, 1X/DAY | 0 | 10 | MG | QD | |||||||
| 127175041 | 12717504 | 4 | C | LISINOPRIL. | LISINOPRIL | 1 | Oral | 5 MG, 1X/DAY | 0 | 5 | MG | QD | |||||||
| 127175041 | 12717504 | 5 | C | BYDUREON | EXENATIDE | 1 | Subcutaneous | 2 MG, 1X/WEEK | 0 | 2 | MG | /wk |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127175041 | 12717504 | 1 | Neuralgia |
| 127175041 | 12717504 | 2 | Type 2 diabetes mellitus |
| 127175041 | 12717504 | 3 | Type 2 diabetes mellitus |
| 127175041 | 12717504 | 4 | Prophylaxis |
| 127175041 | 12717504 | 5 | Type 2 diabetes mellitus |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127175041 | 12717504 | Drug ineffective | |
| 127175041 | 12717504 | 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 |
|---|---|---|---|---|---|---|
| 127175041 | 12717504 | 1 | 2014 | 0 | ||
| 127175041 | 12717504 | 4 | 201508 | 0 |