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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127838591 | 12783859 | 1 | I | 20130916 | 20160912 | 20160927 | 20160927 | EXP | US-AMNEAL PHARMACEUTICALS-2016AMN00626 | AMNEAL | 53.00 | YR | F | Y | 90.70000 | KG | 20160927 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127838591 | 12783859 | 1 | PS | NAPROXEN. | NAPROXEN | 1 | Oral | UNK, 3X/DAY | Y | U | 75927 | TID | |||||||
| 127838591 | 12783859 | 2 | SS | NAPROXEN. | NAPROXEN | 1 | Y | U | 75927 | ||||||||||
| 127838591 | 12783859 | 3 | C | NEXIUM | ESOMEPRAZOLE MAGNESIUM | 1 | UNK | Y | U | 0 | |||||||||
| 127838591 | 12783859 | 4 | C | LEVOTHYROXINE SODIUM. | LEVOTHYROXINE SODIUM | 1 | UNK | U | U | 0 | |||||||||
| 127838591 | 12783859 | 5 | C | METFORMIN HYDROCHLORIDE. | METFORMIN HYDROCHLORIDE | 1 | UNK | U | U | 0 | |||||||||
| 127838591 | 12783859 | 6 | C | TRICOR | FENOFIBRATE | 1 | UNK | U | U | 0 | |||||||||
| 127838591 | 12783859 | 7 | C | LANTUS | INSULIN GLARGINE | 1 | UNK | U | U | 0 | |||||||||
| 127838591 | 12783859 | 8 | C | NEURONTIN | GABAPENTIN | 1 | UNK | U | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127838591 | 12783859 | 1 | Osteoarthritis |
| 127838591 | 12783859 | 2 | Rheumatoid arthritis |
| 127838591 | 12783859 | 3 | Prophylaxis against gastrointestinal ulcer |
| 127838591 | 12783859 | 4 | Hypothyroidism |
| 127838591 | 12783859 | 5 | Type 2 diabetes mellitus |
| 127838591 | 12783859 | 6 | Dyslipidaemia |
| 127838591 | 12783859 | 7 | Diabetes mellitus |
| 127838591 | 12783859 | 8 | Neuralgia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127838591 | 12783859 | HO |
| 127838591 | 12783859 | LT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127838591 | 12783859 | Myocardial infarction |
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 |
|---|---|---|---|---|---|---|
| 127838591 | 12783859 | 1 | 20130209 | 20130915 | 0 | |
| 127838591 | 12783859 | 3 | 20130209 | 20130915 | 0 | |
| 127838591 | 12783859 | 4 | 20120210 | 0 | ||
| 127838591 | 12783859 | 5 | 20100415 | 0 | ||
| 127838591 | 12783859 | 6 | 20120517 | 0 | ||
| 127838591 | 12783859 | 7 | 20130606 | 0 | ||
| 127838591 | 12783859 | 8 | 20100415 | 0 |