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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 6797746 | 7418917 | F | 1 | 6797746-7 | 20100113 | 20100608 | 20100623 | EXP | AUR-APL-2010-01365 | AUROBINDO PHARMA USA | 54 | YR | M | N | 83 | KG | 20100621 | MD |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 6797746 | 1013966276 | PS | METFORMIN HCL | 1 | ORAL | 500MG, QD, ORAL | Y | D | 77095 | ||
| 6797746 | 1014011926 | SS | CRESTOR | 1 | ORAL | 10MG, QD, ORAL | Y | D | |||
| 6797746 | 1014011932 | SS | JANUMET | 1 | ORAL | 50/1000MG, BID, ORAL | Y | D | |||
| 6797746 | 1014011935 | SS | ACTOS | 1 | ORAL | 15MG, DAILY, ORAL | Y | D | |||
| 6797746 | 1014011937 | SS | OMACOR | 1 | ORAL | 1000MG, QID, ORAL | Y | D | |||
| 6797746 | 1014011939 | SS | ALLOPURINOL | 1 | ORAL | 150MG, DAILY, ORAL | Y | D | |||
| 6797746 | 1014011940 | SS | RASILEZ | 2 | ORAL | 150MG, DAILY, ORAL | Y | D | |||
| 6797746 | 1014011942 | C | RAMIPRIL | 1 | |||||||
| 6797746 | 1014011943 | C | METOHEXAL | 2 | |||||||
| 6797746 | 1014011944 | C | SIMVAHEXAL | 2 |
Indications of drugs used
| Event ID | DRUG SEQ | INDI PT |
|---|---|---|
| 6797746 | 1013966276 | TYPE 2 DIABETES MELLITUS |
| 6797746 | 1014011926 | HYPERLIPIDAEMIA |
| 6797746 | 1014011932 | TYPE 2 DIABETES MELLITUS |
| 6797746 | 1014011935 | TYPE 2 DIABETES MELLITUS |
| 6797746 | 1014011937 | HYPERTRIGLYCERIDAEMIA |
| 6797746 | 1014011939 | HYPERURICAEMIA |
| 6797746 | 1014011940 | HYPERTENSION |
Outcome of event
| Event ID | OUTC COD |
|---|---|
| 6797746 | HO |
Reactions reported
| Event ID | PT |
|---|---|
| 6797746 | ALANINE AMINOTRANSFERASE INCREASED |
| 6797746 | ANTINEUTROPHIL CYTOPLASMIC ANTIBODY POSITIVE |
| 6797746 | ASPARTATE AMINOTRANSFERASE INCREASED |
| 6797746 | AUTOIMMUNE HEPATITIS |
| 6797746 | FATIGUE |
| 6797746 | GAMMA-GLUTAMYLTRANSFERASE INCREASED |
| 6797746 | REFUSAL OF TREATMENT BY PATIENT |
Reporting Sources (this data is often not reported and may therefore be missing here)
| Event ID | RPSR COD |
|---|---|
| 6797746 | FGN |
| 6797746 | HP |
| 6797746 | OTH |
Therapies reported
| Event ID | DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|
| 6797746 | 1013966276 | 20080701 | 20100422 | ||
| 6797746 | 1014011926 | 20091008 | 20100423 | ||
| 6797746 | 1014011932 | 20090101 | 20100423 | ||
| 6797746 | 1014011935 | 20090713 | 20100423 | ||
| 6797746 | 1014011937 | 20080701 | 20100423 | ||
| 6797746 | 1014011939 | 20100423 | |||
| 6797746 | 1014011940 | 20070101 | 20100423 |