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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 7205507 | 7550730 | F | 7205507-X | 20100616 | 20101228 | 20101231 | EXP | PHHY2010JP46759 | NOVARTIS PHARMACEUTICAL CORPORATION | 71 | YR | F | Y | 68 | KG | 20101231 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 7205507 | 1015449412 | PS | SANDIMMUNE | 1 | INTRAVENOUS DRIP | 50 MG, BID | 050573 | ||||
| 7205507 | 1015449413 | SS | SANDIMMUNE | 1 | INTRAVENOUS DRIP | 40 MG, BID | 050573 | ||||
| 7205507 | 1015449414 | SS | SANDIMMUNE | 1 | INTRAVENOUS DRIP | 20 MG DAILY | 050573 | ||||
| 7205507 | 1015449415 | SS | SANDIMMUNE | 1 | INTRAVENOUS DRIP | 20 MG, BID | 050573 | ||||
| 7205507 | 1015449416 | SS | NEORAL | 1 | ORAL | UNK | |||||
| 7205507 | 1015449417 | SS | NEORAL | 1 | |||||||
| 7205507 | 1015449418 | SS | TAKEPRON | 2 | INTRAVENOUS | 60 MG, BID | |||||
| 7205507 | 1015449419 | C | PREDONINE | 2 | INTRAVENOUS | 35 MG | |||||
| 7205507 | 1015449420 | C | PREDNISOLONE | 1 | ORAL | UNK |
Indications of drugs used
| Event ID | DRUG SEQ | INDI PT |
|---|---|---|
| 7205507 | 1015449412 | SYSTEMIC LUPUS ERYTHEMATOSUS |
| 7205507 | 1015449416 | THROMBOCYTOPENIA |
| 7205507 | 1015449417 | SYSTEMIC LUPUS ERYTHEMATOSUS |
| 7205507 | 1015449418 | GASTRIC ULCER PERFORATION |
| 7205507 | 1015449419 | SYSTEMIC LUPUS ERYTHEMATOSUS |
| 7205507 | 1015449420 | SYSTEMIC LUPUS ERYTHEMATOSUS |
Outcome of event
| Event ID | OUTC COD |
|---|---|
| 7205507 | DE |
| 7205507 | LT |
| 7205507 | OT |
Reactions reported
| Event ID | PT |
|---|---|
| 7205507 | ALANINE AMINOTRANSFERASE INCREASED |
| 7205507 | ASPARTATE AMINOTRANSFERASE INCREASED |
| 7205507 | BILIRUBIN CONJUGATED |
| 7205507 | BLOOD BILIRUBIN INCREASED |
| 7205507 | BLOOD POTASSIUM DECREASED |
| 7205507 | BLOOD PRESSURE DECREASED |
| 7205507 | GASTRIC ULCER PERFORATION |
| 7205507 | GASTROINTESTINAL HAEMORRHAGE |
| 7205507 | JAUNDICE |
| 7205507 | LIVER DISORDER |
| 7205507 | RESPIRATORY ARREST |
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 |
|---|---|---|---|---|---|
| 7205507 | 1015449412 | 20100611 | 20100615 | 5 | DAY |
| 7205507 | 1015449413 | 20100616 | 20100627 | 12 | DAY |
| 7205507 | 1015449414 | 20100628 | 20100628 | 1 | DAY |
| 7205507 | 1015449415 | 20100629 | 20100701 | 3 | DAY |
| 7205507 | 1015449416 | 20100507 | 20100609 | 34 | DAY |
| 7205507 | 1015449418 | 20100611 | 20100707 | 27 | DAY |
| 7205507 | 1015449419 | 20100610 | |||
| 7205507 | 1015449420 | 19801201 | 20100609 |