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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 4397544 | 5747168 | I | 4397544-8 | 20040623 | 20040708 | EXP | 2004-DE-03479GD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 4397544 | 1005012555 | PS | CYCLOPHOSPHAMIDE | 1 | INTRAVENOUS | IV | D | D | 40032 | ||
| 4397544 | 1005036723 | SS | BUSULPHAN (BUSULPHAN) | 2 | INTRAVENOUS | IV | D | D | |||
| 4397544 | 1005036738 | SS | ANTI-THYMOCYTE GLOBULIN (ANTITHYMOCYTE IMMUNOGLOBULIN) | 2 | INTRAVENOUS | IV | D | D |
Indications of drugs used
| Event ID | DRUG SEQ | INDI PT |
|---|---|---|
| 4397544 | 1005012555 | BONE MARROW CONDITIONING REGIMEN |
| 4397544 | 1005036723 | BONE MARROW CONDITIONING REGIMEN |
| 4397544 | 1005036738 | BONE MARROW CONDITIONING REGIMEN |
Outcome of event
| Event ID | OUTC COD |
|---|---|
| 4397544 | HO |
| 4397544 | RI |
Reactions reported
| Event ID | PT |
|---|---|
| 4397544 | BLOOD CULTURE POSITIVE |
| 4397544 | CIRCULATORY COLLAPSE |
| 4397544 | COUGH |
| 4397544 | CYTOMEGALOVIRUS INFECTION |
| 4397544 | DILATATION VENTRICULAR |
| 4397544 | FLOPPY INFANT |
| 4397544 | GRAFT VERSUS HOST DISEASE |
| 4397544 | HYPOTONIA |
| 4397544 | LUNG INFECTION |
| 4397544 | OXYGEN SATURATION DECREASED |
| 4397544 | PALLOR |
| 4397544 | PULMONARY HYPERTENSION |
| 4397544 | PULMONARY TOXICITY |
| 4397544 | PULMONARY VENO-OCCLUSIVE DISEASE |
| 4397544 | RESPIRATORY FAILURE |
| 4397544 | RHINITIS |
| 4397544 | SHOCK |
| 4397544 | STREPTOCOCCAL INFECTION |
| 4397544 | TACHYPNOEA |
| 4397544 | TRICUSPID VALVE INCOMPETENCE |
| 4397544 | VENOOCCLUSIVE DISEASE |
| 4397544 | VENTRICULAR DYSFUNCTION |
| 4397544 | VOMITING |
Reporting Sources (this data is often not reported and may therefore be missing here)
| Event ID | RPSR COD |
|---|---|
| 4397544 | FGN |
| 4397544 | LIT |
Therapies reported
| no results found |