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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 5195435 | 6201831 | F | 5195435-6 | 20050912 | 20061219 | 20061230 | EXP | JP-NOVOPROD-259485 | NOVOPROD | 83 | YR | F | Y | 34 | KG | 20061230 | MD | 20060303 | JAPAN |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 5195435 | 1007999401 | PS | NOVORAPID CHU | 2 | SUBCUTANEOUS | 18-32 IU, QD | 20986 | ||||
| 5195435 | 1007999402 | SS | NOVOLIN N | 1 | SUBCUTANEOUS | 4 IU, QD | 019959 | ||||
| 5195435 | 1007999403 | C | RADEN | 2 | ORAL | 150 MG, UNK | |||||
| 5195435 | 1007999404 | C | GLORIAMIN | 2 | ORAL | .5 G, UNK | |||||
| 5195435 | 1007999405 | C | ATARAX | 1 | ORAL | 25 MG, QD | |||||
| 5195435 | 1007999406 | C | PREDONINE /00016201/ | 2 | ORAL | 2.5 MG, QD | |||||
| 5195435 | 1007999407 | C | HALCION | 1 | ORAL | .125 MG, QD |
Indications of drugs used
| Event ID | DRUG SEQ | INDI PT |
|---|---|---|
| 5195435 | 1007999401 | INSULIN-REQUIRING TYPE II DIABETES MELLITUS |
| 5195435 | 1007999402 | INSULIN-REQUIRING TYPE II DIABETES MELLITUS |
Outcome of event
| Event ID | OUTC COD |
|---|---|
| 5195435 | DE |
| 5195435 | HO |
| 5195435 | LT |
Reactions reported
| Event ID | PT |
|---|---|
| 5195435 | ALANINE AMINOTRANSFERASE INCREASED |
| 5195435 | ASPARTATE AMINOTRANSFERASE INCREASED |
| 5195435 | BILIARY DILATATION |
| 5195435 | BLOOD ALKALINE PHOSPHATASE INCREASED |
| 5195435 | CHOLANGITIS ACUTE |
| 5195435 | GAMMA-GLUTAMYLTRANSFERASE INCREASED |
| 5195435 | GASTRIC CANCER |
| 5195435 | HAEMOGLOBIN DECREASED |
| 5195435 | HEPATIC ENZYME INCREASED |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| Event ID | DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|
| 5195435 | 1007999401 | 20031002 | |||
| 5195435 | 1007999403 | 20000407 | 20050927 | 1999 | DAY |
| 5195435 | 1007999404 | 20000407 | 20050927 | 1999 | DAY |
| 5195435 | 1007999405 | 20000407 | 20050927 | 1999 | DAY |
| 5195435 | 1007999406 | 20010704 | 20050927 | 1546 | DAY |
| 5195435 | 1007999407 | 20030814 | 20050927 | 775 | DAY |