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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 4397545 | 5747274 | I | 4397545-X | 20040623 | 20040708 | EXP | 2004-DE-03482GD | ROXANE LABORATORIES, INC. | F | N | 20040706 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 4397545 | 1005012556 | PS | CYCLOPHOSPHAMIDE | 1 | INTRAVENOUS | IV | D | D | 40032 | ||
| 4397545 | 1005036774 | SS | BUSULPHAN (BUSULPHAN) | 2 | INTRAVENOUS | IV | D | D | |||
| 4397545 | 1005036775 | SS | ANTI-THYMOCYTE GLOBULIN (ANTITHYMOCYTE IMMUNOGLOBULIN) | 2 | INTRAVENOUS | IV | D | D |
Indications of drugs used
| Event ID | DRUG SEQ | INDI PT |
|---|---|---|
| 4397545 | 1005012556 | BONE MARROW CONDITIONING REGIMEN |
| 4397545 | 1005036774 | BONE MARROW CONDITIONING REGIMEN |
| 4397545 | 1005036775 | BONE MARROW CONDITIONING REGIMEN |
Outcome of event
| Event ID | OUTC COD |
|---|---|
| 4397545 | DE |
| 4397545 | RI |
Reactions reported
| Event ID | PT |
|---|---|
| 4397545 | ACUTE RESPIRATORY DISTRESS SYNDROME |
| 4397545 | ARRHYTHMIA |
| 4397545 | CARDIAC FAILURE |
| 4397545 | COMA |
| 4397545 | ELECTROENCEPHALOGRAM ABNORMAL |
| 4397545 | GASTROOESOPHAGEAL REFLUX DISEASE |
| 4397545 | GRAFT VERSUS HOST DISEASE |
| 4397545 | LETHARGY |
| 4397545 | LUNG INFECTION |
| 4397545 | PULMONARY HYPERTENSION |
| 4397545 | PULMONARY TOXICITY |
| 4397545 | PYREXIA |
| 4397545 | THERAPY NON-RESPONDER |
| 4397545 | VENOOCCLUSIVE LIVER DISEASE |
| 4397545 | VOMITING |
Reporting Sources (this data is often not reported and may therefore be missing here)
| Event ID | RPSR COD |
|---|---|
| 4397545 | FGN |
| 4397545 | LIT |
Therapies reported
| no results found |