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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125808481 | 12580848 | 1 | I | 20160610 | 20160714 | 20160721 | 20160721 | EXP | GB-MYLANLABS-2016M1029455 | MYLAN | 0.00 | Y | 0.00000 | 20160721 | OT | GB | GB |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125808481 | 12580848 | 1 | PS | ATORVASTATIN | ATORVASTATIN | 1 | Oral | 80 MG, UNK | UNKNOWN | 91226 | 80 | MG | |||||||
| 125808481 | 12580848 | 2 | C | INSULATARD /00646002/ | INSULIN HUMAN | 1 | Unknown | UNK | U | 0 | |||||||||
| 125808481 | 12580848 | 3 | C | ISOSORBIDE MONONITRATE. | ISOSORBIDE MONONITRATE | 1 | Unknown | UNK | U | 0 | |||||||||
| 125808481 | 12580848 | 4 | C | NOVORAPID | INSULIN ASPART | 1 | Unknown | UNK | U | 0 | |||||||||
| 125808481 | 12580848 | 5 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | Unknown | UNK | U | 0 | |||||||||
| 125808481 | 12580848 | 6 | C | RAMIPRIL. | RAMIPRIL | 1 | Unknown | UNK | U | 0 |
Indications of drugs used
| no results found |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125808481 | 12580848 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125808481 | 12580848 | Alanine aminotransferase increased | |
| 125808481 | 12580848 | Blood bilirubin increased | |
| 125808481 | 12580848 | Liver function test increased | |
| 125808481 | 12580848 | Weight decreased |
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 |
|---|---|---|---|---|---|---|
| 125808481 | 12580848 | 1 | 20131122 | 0 | ||
| 125808481 | 12580848 | 2 | 20131122 | 0 | ||
| 125808481 | 12580848 | 3 | 20131122 | 0 | ||
| 125808481 | 12580848 | 4 | 20131122 | 0 | ||
| 125808481 | 12580848 | 5 | 20131122 | 0 | ||
| 125808481 | 12580848 | 6 | 20131122 | 0 |