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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126159371 | 12615937 | 1 | I | 2015 | 20160725 | 20160802 | 20160802 | EXP | GB-MHRA-EYC 00142533 | GB-MYLANLABS-2016M1030715 | MYLAN | 0.00 | Y | 0.00000 | 20160802 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126159371 | 12615937 | 1 | PS | SIMVASTATIN. | SIMVASTATIN | 1 | Oral | UNK | 90868 | ||||||||||
| 126159371 | 12615937 | 2 | SS | OMEPRAZOLE. | OMEPRAZOLE | 1 | Oral | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126159371 | 12615937 | 1 | Blood cholesterol increased |
| 126159371 | 12615937 | 2 | Dyspepsia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126159371 | 12615937 | LT |
| 126159371 | 12615937 | DS |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126159371 | 12615937 | Abnormal loss of weight | |
| 126159371 | 12615937 | Amyloidosis | |
| 126159371 | 12615937 | Arthralgia | |
| 126159371 | 12615937 | Asthenia | |
| 126159371 | 12615937 | Back pain | |
| 126159371 | 12615937 | Constipation | |
| 126159371 | 12615937 | Decreased appetite | |
| 126159371 | 12615937 | Dysgeusia | |
| 126159371 | 12615937 | Dyspepsia | |
| 126159371 | 12615937 | Fatigue | |
| 126159371 | 12615937 | Hyperproteinaemia | |
| 126159371 | 12615937 | Hypotension | |
| 126159371 | 12615937 | Muscle atrophy | |
| 126159371 | 12615937 | Muscle spasms |
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 |
|---|---|---|---|---|---|---|
| 126159371 | 12615937 | 1 | 201510 | 0 | ||
| 126159371 | 12615937 | 2 | 201510 | 0 |