Person who experienced the adverse event (patient)
| Event ID | CASE | I F COD | FOLL SEQ | IMAGE | EVENT DT | MFR DT | FDA DT | REPT COD | MFR NUM | MFR SNDR | AGE | AGE COD | GNDR COD | E SUB | WT | WT COD | REPT DT | OCCP COD | DEATH DT | TO MFR | CONFID | REPORTER COUNTRY |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 6771431 | 7426843 | F | 1 | 6771431-X | 20100422 | 20100528 | 20100614 | EXP | AUR-APL-2010-01334 | AUROBINDO PHARMA USA | 66 | YR | F | N | 69.85 | KG | 20100611 | OT |
Drug(s) used by person
| Event ID | DRUG SEQ | ROLE COD | DRUGNAME | VAL VBM | ROUTE | DOSE VBM | DECHAL | RECHAL | LOT NUM | EXP DT | NDA NUM |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 6771431 | 1013874155 | PS | SIMVASTATIN | 2 | ORAL | 40MG, ORAL | N | D | 77691 | ||
| 6771431 | 1013907105 | C | ADALAT | 1 | |||||||
| 6771431 | 1013907106 | C | ASPIRIN | 1 | |||||||
| 6771431 | 1013907107 | C | BENDROFLUMETHIAZIDE | 2 | |||||||
| 6771431 | 1013907108 | C | OPTIVE | 2 |
Indications of drugs used
| Event ID | DRUG SEQ | INDI PT |
|---|---|---|
| 6771431 | 1013874155 | BLOOD CHOLESTEROL INCREASED |
Outcome of event
| Event ID | OUTC COD |
|---|---|
| 6771431 | OT |
Reactions reported
| Event ID | PT |
|---|---|
| 6771431 | LIP ULCERATION |
| 6771431 | MOUTH ULCERATION |
| 6771431 | PAIN |
Reporting Sources (this data is often not reported and may therefore be missing here)
| Event ID | RPSR COD |
|---|---|
| 6771431 | FGN |
| 6771431 | HP |
| 6771431 | OTH |
Therapies reported
| Event ID | DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|
| 6771431 | 1013874155 | 20100416 | 20100428 |