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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125268391 | 12526839 | 1 | I | 20160621 | 20160705 | 20160705 | EXP | US-CIPLA LTD.-2016US08216 | CIPLA | REARDON DA, DESJARDINS A, PETERS KB, GURURANGAN S, SAMPSON JH, MCLENDON RE, ET.AL,. 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 | 20160705 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125268391 | 12526839 | 1 | PS | CARBOPLATIN. | CARBOPLATIN | 1 | Unknown | AUC 4 MG/ML ON DAY 1 OF THE STUDY | U | U | 77383 | ||||||||
| 125268391 | 12526839 | 2 | SS | Irinotecan | IRINOTECAN | 1 | Unknown | UNK | U | U | 0 | 340 | MG/M**2 | ||||||
| 125268391 | 12526839 | 3 | SS | TEMOZOLOMIDE. | TEMOZOLOMIDE | 1 | Unknown | UNK | U | U | 0 | ||||||||
| 125268391 | 12526839 | 4 | SS | OXCARBAZEPINE. | OXCARBAZEPINE | 1 | Unknown | UNK | U | U | 0 | ||||||||
| 125268391 | 12526839 | 5 | SS | Bevacizumab | BEVACIZUMAB | 1 | Intravenous (not otherwise specified) | 10 MG/M2, ON DAYS 1 AND 14 OF THE STUDY | U | U | 0 | 10 | MG/M**2 | ||||||
| 125268391 | 12526839 | 6 | SS | PHENYTOIN. | PHENYTOIN | 1 | Unknown | UNK | U | U | 0 | ||||||||
| 125268391 | 12526839 | 7 | SS | PHENOBARBITAL. | PHENOBARBITAL | 1 | Unknown | UNK | U | U | 0 | ||||||||
| 125268391 | 12526839 | 8 | SS | CARBAMAZEPINE. | CARBAMAZEPINE | 1 | Unknown | UNK | U | U | 0 | ||||||||
| 125268391 | 12526839 | 9 | SS | PRIMIDONE. | PRIMIDONE | 1 | Unknown | UNK | U | U | 0 | ||||||||
| 125268391 | 12526839 | 10 | C | DEXAMETHASONE. | DEXAMETHASONE | 1 | Unknown | UNK | U | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125268391 | 12526839 | 1 | Malignant glioma |
| 125268391 | 12526839 | 2 | Malignant glioma |
| 125268391 | 12526839 | 3 | Malignant glioma |
| 125268391 | 12526839 | 5 | Malignant glioma |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125268391 | 12526839 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125268391 | 12526839 | Disease progression | |
| 125268391 | 12526839 | Proteinuria |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |