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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126480521 | 12648052 | 1 | I | 2015 | 20160801 | 20160812 | 20160812 | EXP | GB-AUROBINDO-AUR-APL-2016-10038 | AUROBINDO | 83.00 | YR | M | Y | 97.50000 | KG | 20160812 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126480521 | 12648052 | 1 | PS | OMEPRAZOLE. | OMEPRAZOLE | 1 | Oral | UNK | 203270 | ||||||||||
| 126480521 | 12648052 | 2 | SS | SIMVASTATIN. | SIMVASTATIN | 1 | Oral | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126480521 | 12648052 | 1 | Dyspepsia |
| 126480521 | 12648052 | 2 | Blood cholesterol increased |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126480521 | 12648052 | DS |
| 126480521 | 12648052 | LT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126480521 | 12648052 | Abnormal loss of weight | |
| 126480521 | 12648052 | Amyloidosis | |
| 126480521 | 12648052 | Arthralgia | |
| 126480521 | 12648052 | Asthenia | |
| 126480521 | 12648052 | Back pain | |
| 126480521 | 12648052 | Constipation | |
| 126480521 | 12648052 | Decreased appetite | |
| 126480521 | 12648052 | Dysgeusia | |
| 126480521 | 12648052 | Dyspepsia | |
| 126480521 | 12648052 | Fatigue | |
| 126480521 | 12648052 | Hyperproteinaemia | |
| 126480521 | 12648052 | Hypotension | |
| 126480521 | 12648052 | Muscle atrophy | |
| 126480521 | 12648052 | 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 |
|---|---|---|---|---|---|---|
| 126480521 | 12648052 | 1 | 201510 | 0 | ||
| 126480521 | 12648052 | 2 | 201510 | 0 |