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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
125245211 | 12524521 | 1 | I | 20160621 | 20160704 | 20160704 | EXP | US-CIPLA LTD.-2016US08212 | CIPLA | REARDON DA, DESJARDINS A, PETERS KB, GURURANGAN S, SAMPSON JH, MCLENDON RE. PHASE II STUDY OF CARBOPLATIN, IRINOTECAN, AND BEVACIZUMAB FOR BEVACIZUMAB NAIVE, RECURRENT GLIOBLASTOMA. J NEUROONCOL. 2012;107:155 TO 164 | 0.00 | Y | 0.00000 | 20160704 | OT | US | US |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
125245211 | 12524521 | 1 | PS | CARBOPLATIN. | CARBOPLATIN | 1 | Unknown | AUC 4 MG/ML-MIN, ON DAY 1 OF EACH 28-DAY CYCLE | 77383 | ||||||||||
125245211 | 12524521 | 2 | SS | Irinotecan | IRINOTECAN | 1 | Unknown | 340 MG/M2 OR 125 MG/M2 ON DAYS 1 AND 14 OF EVERY 28-DAY CYCLE | 0 | ||||||||||
125245211 | 12524521 | 3 | SS | TEMOZOLOMIDE. | TEMOZOLOMIDE | 1 | Unknown | UNK | 0 | ||||||||||
125245211 | 12524521 | 4 | SS | Bevacizumab | BEVACIZUMAB | 1 | Intravenous (not otherwise specified) | 10 MG/KG, EVERY 14 DAYS | 0 | 10 | MG/KG | INJECTION | |||||||
125245211 | 12524521 | 5 | C | DEXAMETHASONE. | DEXAMETHASONE | 1 | Unknown | UNK | U | U | 0 |
Indications of drugs used
Event ID | CASEID | INDI DRUG SEQ | INDI PT |
---|---|---|---|
125245211 | 12524521 | 1 | Malignant glioma |
125245211 | 12524521 | 2 | Malignant glioma |
125245211 | 12524521 | 3 | Malignant glioma |
125245211 | 12524521 | 4 | Glioblastoma multiforme |
Outcome of event
Event ID | CASEID | OUTC COD |
---|---|---|
125245211 | 12524521 | OT |
Reactions reported
Event ID | CASEID | DRUG REC ACT | PT |
---|---|---|---|
125245211 | 12524521 | Disease progression |
Reporting Sources (this data is often not reported and may therefore be missing here)
no results found |
Therapies reported
no results found |