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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127693541 | 12769354 | 1 | I | 201405 | 20160908 | 20160921 | 20160921 | EXP | US-AMNEAL PHARMACEUTICALS-2016AMN00552 | AMNEAL | 52.00 | YR | F | Y | 91.00000 | KG | 20160921 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127693541 | 12769354 | 1 | PS | NAPROXEN. | NAPROXEN | 1 | Oral | UNK, 3X/DAY | Y | U | 75927 | TID | |||||||
| 127693541 | 12769354 | 2 | C | NEXIUM | ESOMEPRAZOLE MAGNESIUM | 1 | UNK | Y | U | 0 | |||||||||
| 127693541 | 12769354 | 3 | C | AMLODIPINE | AMLODIPINE BESYLATE | 1 | UNK | 0 | |||||||||||
| 127693541 | 12769354 | 4 | C | ATENOLOL. | ATENOLOL | 1 | Oral | UNK | 0 | ||||||||||
| 127693541 | 12769354 | 5 | C | insulin | INSULIN NOS | 1 | UNK | 0 | |||||||||||
| 127693541 | 12769354 | 6 | C | PREDNISONE. | PREDNISONE | 1 | UNK | 0 | |||||||||||
| 127693541 | 12769354 | 7 | C | METHOTREXATE. | METHOTREXATE | 1 | UNK | 0 | |||||||||||
| 127693541 | 12769354 | 8 | C | IRBESARTAN. | IRBESARTAN | 1 | UNK | 0 | |||||||||||
| 127693541 | 12769354 | 9 | C | CLOPIDOGREL | CLOPIDOGREL BISULFATE | 1 | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127693541 | 12769354 | 1 | Arthritis |
| 127693541 | 12769354 | 2 | Prophylaxis |
| 127693541 | 12769354 | 3 | Hypertension |
| 127693541 | 12769354 | 4 | Hypertension |
| 127693541 | 12769354 | 5 | Diabetes mellitus |
| 127693541 | 12769354 | 6 | Rheumatoid arthritis |
| 127693541 | 12769354 | 7 | Rheumatoid arthritis |
| 127693541 | 12769354 | 8 | Hypertension |
| 127693541 | 12769354 | 9 | Cerebrovascular accident |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127693541 | 12769354 | LT |
| 127693541 | 12769354 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127693541 | 12769354 | Angina unstable |
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 |
|---|---|---|---|---|---|---|
| 127693541 | 12769354 | 1 | 20121013 | 20131110 | 0 | |
| 127693541 | 12769354 | 2 | 20121013 | 20131216 | 0 | |
| 127693541 | 12769354 | 3 | 1980 | 0 | ||
| 127693541 | 12769354 | 4 | 1980 | 0 | ||
| 127693541 | 12769354 | 5 | 2009 | 0 | ||
| 127693541 | 12769354 | 6 | 201201 | 0 | ||
| 127693541 | 12769354 | 7 | 20121112 | 0 | ||
| 127693541 | 12769354 | 8 | 20130508 | 0 | ||
| 127693541 | 12769354 | 9 | 20130614 | 0 |