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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 4542784 | 4190006 | F | 4542784-8 | 20031201 | 20040608 | 20041231 | EXP | PHBS2004JP07535 | NOVARTIS PHARMACEUTICALS CORP. | 54 | YR | M | Y | 68 | KG | 20041231 | MD | 20040621 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 4542784 | 1005547031 | PS | GLEEVEC | 1 | ORAL | ||||||
| 4542784 | 1005547032 | SS | GLEEVEC | 1 | ORAL | UNK, UNK | |||||
| 4542784 | 1005547033 | C | ADALAT CC | 1 | |||||||
| 4542784 | 1005547034 | C | ZYLORIC | 2 |
Indications of drugs used
| Event ID | DRUG SEQ | INDI PT |
|---|---|---|
| 4542784 | 1005547031 | CHRONIC MYELOID LEUKAEMIA |
Outcome of event
| Event ID | OUTC COD |
|---|---|
| 4542784 | DE |
| 4542784 | HO |
| 4542784 | LT |
| 4542784 | OT |
Reactions reported
| Event ID | PT |
|---|---|
| 4542784 | BLOOD BILIRUBIN INCREASED |
| 4542784 | COMA HEPATIC |
| 4542784 | DEPRESSED LEVEL OF CONSCIOUSNESS |
| 4542784 | DYSPEPSIA |
| 4542784 | FATIGUE |
| 4542784 | HAEMOGLOBIN DECREASED |
| 4542784 | HEPATIC ENCEPHALOPATHY |
| 4542784 | HEPATITIS |
| 4542784 | HEPATITIS B |
| 4542784 | HYPOTENSION |
| 4542784 | JAUNDICE |
| 4542784 | LIVER FUNCTION TEST ABNORMAL |
| 4542784 | LYMPHOPENIA |
| 4542784 | MALAISE |
| 4542784 | MULTI-ORGAN FAILURE |
| 4542784 | NEUTROPENIA |
| 4542784 | PLATELET COUNT DECREASED |
| 4542784 | PNEUMONIA |
| 4542784 | PROTHROMBIN TIME PROLONGED |
| 4542784 | RED BLOOD CELL COUNT DECREASED |
| 4542784 | RESPIRATORY DISTRESS |
| 4542784 | WHITE BLOOD CELL COUNT DECREASED |
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 |
|---|---|---|---|---|---|
| 4542784 | 1005547031 | 20031125 | 20040511 | 169 | DAY |
| 4542784 | 1005547032 | 20031015 | 20031124 | 59040 | MIN |
| 4542784 | 1005547033 | 20031015 | 20040511 | 210 | DAY |
| 4542784 | 1005547034 | 20031015 | 20040511 | 210 | DAY |