Person who experienced the adverse event (patient)
| Event ID | CASEID | CASEVERSION | I F COD | EVENT DT | MFR DT | INIT FDA DT | FDA DT | REPT COD | AUTH NUM | MFR NUM | MFR SNDR | LIT REF | AGE | AGE COD | AGE GRP | GNDR COD | E SUB | WT | WT COD | REPT DT | TO MFR | OCCP COD | REPORTER COUNTRY | OCCR COUNTRY |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126280732 | 12628073 | 2 | F | 20160808 | 20160808 | 20160823 | EXP | IT-MINISAL02-368934 | IT-CIPLA LTD.-2016IT16962 | CIPLA | 0.00 | Y | 0.00000 | 20160823 | OT | IT | IT |
Drug(s) used by person
| Event ID | CASEID | DRUG SEQ | ROLE COD | DRUGNAME | PROD AI | VAL VBM | ROUTE | DOSE VBM | CUM DOSE CHR | CUM DOSE UNIT | DECHAL | RECHAL | LOT NUM | EXP DT | NDA NUM | DOSE AMT | DOSE UNIT | DOSE FORM | DOSE FREQ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126280732 | 12628073 | 1 | PS | CARBOPLATIN. | CARBOPLATIN | 1 | Unknown | 25 MG/KG, IN PHASE A | 77383 | 25 | MG/KG | ||||||||
| 126280732 | 12628073 | 2 | SS | CARBOPLATIN. | CARBOPLATIN | 1 | Unknown | 50 MG/KG, IN PHASE B | 77383 | 50 | MG/KG | ||||||||
| 126280732 | 12628073 | 3 | SS | ETOPOSIDE. | ETOPOSIDE | 1 | Unknown | 80 MG/KG, IN PHASE A | 0 | 80 | MG/KG | ||||||||
| 126280732 | 12628073 | 4 | SS | ETOPOSIDE. | ETOPOSIDE | 1 | Unknown | 50 MG/KG, IN PHASE B | 0 | 50 | MG/KG | ||||||||
| 126280732 | 12628073 | 5 | SS | Vincristine | VINCRISTINE | 1 | Unknown | 0.04 MG/KG,IN PHASE A | 0 | .04 | MG/KG | ||||||||
| 126280732 | 12628073 | 6 | SS | METHOTREXATE. | METHOTREXATE | 1 | Unknown | 250 MG/KG, IN PHASE A | 0 | 250 | MG/KG | ||||||||
| 126280732 | 12628073 | 7 | SS | METHOTREXATE. | METHOTREXATE | 1 | Unknown | UNK, HIGH DOSE | 0 | ||||||||||
| 126280732 | 12628073 | 8 | SS | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | Unknown | 135 MG/KG, UNK | 0 | 135 | MG/KG | ||||||||
| 126280732 | 12628073 | 9 | SS | THIOTEPA. | THIOTEPA | 1 | Unknown | 10 MG/KG/DAY, IN PHASE B | 0 | 10 | MG/KG | ||||||||
| 126280732 | 12628073 | 10 | SS | Melphalan | MELPHALAN | 1 | Unknown | 4 MG/KG/DAY | 0 | 4 | MG/KG | ||||||||
| 126280732 | 12628073 | 11 | C | Granulocyte colony stimulating factors | 2 | Unknown | UNK, GIVEN FROM DAY 35 TO DAY 38 | U | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126280732 | 12628073 | 1 | Glioblastoma multiforme |
| 126280732 | 12628073 | 3 | Glioblastoma multiforme |
| 126280732 | 12628073 | 5 | Glioblastoma multiforme |
| 126280732 | 12628073 | 6 | Glioblastoma multiforme |
| 126280732 | 12628073 | 8 | Glioblastoma multiforme |
| 126280732 | 12628073 | 9 | Glioblastoma multiforme |
| 126280732 | 12628073 | 10 | Glioblastoma multiforme |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126280732 | 12628073 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126280732 | 12628073 | Anaemia | |
| 126280732 | 12628073 | Juvenile melanoma benign | |
| 126280732 | 12628073 | Thrombocytopenia | |
| 126280732 | 12628073 | Transaminases increased |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |