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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 8016633 | 8317519 | I | 8016633-X | 20111227 | 20111231 | EXP | PHHY2011FR112590 | SANDOZ,INC. | YR | M | Y | 18 | KG | 20111231 | OT | FRANCE |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 8016633 | 1018419936 | SS | VINCRISTINE SULFATE | 1 | INTRAVENOUS | 1.2 MG, UNK | |||||
| 8016633 | 1018419937 | SS | CYTARABINE | 1 | INTRATHECAL | 25 MG, UNK | |||||
| 8016633 | 1018419939 | SS | CERUBIDINE | 1 | 31 MG, UNK | ||||||
| 8016633 | 1018419935 | PS | METHOTREXATE | 1 | INTRATHECAL | 12 MG, UNK | 090039 | ||||
| 8016633 | 1018419934 | SS | GLEEVEC | 1 | ORAL | 200 MG, QD | |||||
| 8016633 | 1018419940 | SS | CYCLOPHOSPHAMIDE | 1 | INTRAVENOUS | 780 MG, UNK | |||||
| 8016633 | 1018419938 | SS | KIDROLASE | 2 | INTRAMUSCULAR | 4800 IU, UNK |
Indications of drugs used
| no results found |
Outcome of event
| Event ID | OUTC COD |
|---|---|
| 8016633 | LT |
| 8016633 | OT |
| 8016633 | HO |
Reactions reported
| Event ID | PT |
|---|---|
| 8016633 | ACUTE RESPIRATORY DISTRESS SYNDROME |
| 8016633 | PERICARDIAL EFFUSION |
| 8016633 | GENERALISED OEDEMA |
| 8016633 | URINE OUTPUT DECREASED |
| 8016633 | ASCITES |
| 8016633 | ORAL DISORDER |
| 8016633 | CANDIDIASIS |
| 8016633 | PLEURAL EFFUSION |
| 8016633 | STAPHYLOCOCCAL INFECTION |
| 8016633 | APLASIA |
| 8016633 | HYPOXIA |
| 8016633 | PYREXIA |
| 8016633 | SEPSIS |
| 8016633 | STOMATOCOCCAL INFECTION |
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 |
|---|---|---|---|---|---|
| 8016633 | 1018419936 | 20111006 | 20111013 | 8 | DAY |
| 8016633 | 1018419937 | 20111010 | 20111014 | 5 | DAY |
| 8016633 | 1018419939 | 20111006 | 20111013 | 8 | DAY |
| 8016633 | 1018419935 | 20111003 | 20111014 | 12 | DAY |
| 8016633 | 1018419934 | 20111013 | 20111021 | 9 | DAY |
| 8016633 | 1018419940 | 20111006 | |||
| 8016633 | 1018419938 | 20111006 | 20111014 | 9 | DAY |