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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125300021 | 12530002 | 1 | I | 20160621 | 20160706 | 20160706 | EXP | US-CIPLA LTD.-2016US08410 | CIPLA | GOULD N, SILL MW, MANNEL RS, THAKER PH, DISILVESTRO PA, WAGGONER SE, ET AL. A PHASE I STUDY WITH AN EXPANDED COHORT TO ASSESS FEASIBILITY OF INTRAVENOUS DOCETAXEL, INTRAPERITONEAL CARBOPLATIN AND INTRAPERITONEAL PACLITAXEL IN PATIENTS WITH PREVIOUSLY UNTREATED OVARIAN, FALLOPIAN TUBE OR PRIMARY PERITONEAL CARCINOMA: A GYNECOLOGIC ONCOLOGY GROUP STUDY. GYNECOL ONCOL. 2012;127 (3):506 TO 510 | 0.00 | Y | 0.00000 | 20160706 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125300021 | 12530002 | 1 | PS | CARBOPLATIN. | CARBOPLATIN | 1 | Intraperitoneal | AUC 6, ON DAY 1 | U | U | 0 | INFUSION | |||||||
| 125300021 | 12530002 | 2 | SS | CARBOPLATIN. | CARBOPLATIN | 1 | U | U | 0 | INFUSION | |||||||||
| 125300021 | 12530002 | 3 | SS | CARBOPLATIN. | CARBOPLATIN | 1 | U | U | 0 | INFUSION | |||||||||
| 125300021 | 12530002 | 4 | SS | DOCETAXEL. | DOCETAXEL | 1 | Intravenous (not otherwise specified) | 75 MG/M2, ON DAY 1 | U | U | 0 | 75 | MG/M**2 | ||||||
| 125300021 | 12530002 | 5 | SS | DOCETAXEL. | DOCETAXEL | 1 | U | U | 0 | ||||||||||
| 125300021 | 12530002 | 6 | SS | DOCETAXEL. | DOCETAXEL | 1 | U | U | 0 | ||||||||||
| 125300021 | 12530002 | 7 | SS | PACLITAXEL. | PACLITAXEL | 1 | Intraperitoneal | 60 MG/M2, ON DAY 8 | U | U | 0 | 60 | MG/M**2 | INFUSION | |||||
| 125300021 | 12530002 | 8 | SS | PACLITAXEL. | PACLITAXEL | 1 | U | U | 0 | INFUSION | |||||||||
| 125300021 | 12530002 | 9 | SS | PACLITAXEL. | PACLITAXEL | 1 | U | U | 0 | INFUSION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125300021 | 12530002 | 1 | Ovarian cancer |
| 125300021 | 12530002 | 2 | Malignant peritoneal neoplasm |
| 125300021 | 12530002 | 3 | Fallopian tube cancer |
| 125300021 | 12530002 | 4 | Ovarian cancer |
| 125300021 | 12530002 | 5 | Malignant peritoneal neoplasm |
| 125300021 | 12530002 | 6 | Fallopian tube cancer |
| 125300021 | 12530002 | 7 | Ovarian cancer |
| 125300021 | 12530002 | 8 | Malignant peritoneal neoplasm |
| 125300021 | 12530002 | 9 | Fallopian tube cancer |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125300021 | 12530002 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125300021 | 12530002 | Disease progression |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |