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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 5531272 | 6465252 | F | 1 | 5531272-8 | 20071011 | 20071114 | 20071127 | EXP | TH-JNJFOC-20071006902 | MGI PHARMA, INC. | F | N | 20071121 | MD | THAILAND |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 5531272 | 1009214417 | PS | DECITABINE (DECITABINE) LYOPHILIZED POWDER | 2 | INTRAVENOUS | 29 MG, INTRAVENOUS; 29 MG, INTRAVENOUS | D | D | 21790 | ||
| 5531272 | 1009244579 | C | SODAMINT (SODIUM BICARBONATE) UNSPECIFIED) | 2 |
Indications of drugs used
| Event ID | DRUG SEQ | INDI PT |
|---|---|---|
| 5531272 | 1009214417 | MYELODYSPLASTIC SYNDROME |
Outcome of event
| Event ID | OUTC COD |
|---|---|
| 5531272 | HO |
Reactions reported
| Event ID | PT |
|---|---|
| 5531272 | ABDOMINAL PAIN |
| 5531272 | COLITIS |
| 5531272 | DIARRHOEA |
| 5531272 | HYPOTENSION |
| 5531272 | NEUTROPHIL COUNT DECREASED |
| 5531272 | PYREXIA |
| 5531272 | WHITE BLOOD CELL COUNT DECREASED |
Reporting Sources (this data is often not reported and may therefore be missing here)
| Event ID | RPSR COD |
|---|---|
| 5531272 | FGN |
| 5531272 | HP |
| 5531272 | SDY |
Therapies reported
| Event ID | DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|
| 5531272 | 1009214417 | 20070815 | 20070819 | ||
| 5531272 | 1009214417 | 20070912 | 20070916 |