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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125302131 | 12530213 | 1 | I | 20130226 | 20160706 | 20160706 | EXP | US-CIPLA LTD.-2013US00462 | 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. GYNECOLOGIC ONCOLOGY. 2012;127:506 TO 510 | 0.00 | A | F | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125302131 | 12530213 | 1 | PS | CARBOPLATIN. | CARBOPLATIN | 1 | Intraperitoneal | AUC 5 ON DAY 1 AND AND EACH CYCLE WAS REPEATED EVERY 21 DAYS | U | U | 0 | ||||||||
| 125302131 | 12530213 | 2 | SS | CARBOPLATIN. | CARBOPLATIN | 1 | U | U | 0 | ||||||||||
| 125302131 | 12530213 | 3 | SS | CARBOPLATIN. | CARBOPLATIN | 1 | U | U | 0 | ||||||||||
| 125302131 | 12530213 | 4 | SS | PACLITAXEL. | PACLITAXEL | 1 | Intraperitoneal | 60 MG/M2, ON DAY 8 AND AND EACH CYCLE WAS REPEATED EVERY 21 DAYS. | U | U | 0 | 60 | MG/M**2 | ||||||
| 125302131 | 12530213 | 5 | SS | PACLITAXEL. | PACLITAXEL | 1 | U | U | 0 | ||||||||||
| 125302131 | 12530213 | 6 | SS | PACLITAXEL. | PACLITAXEL | 1 | U | U | 0 | ||||||||||
| 125302131 | 12530213 | 7 | SS | DOCETAXEL. | DOCETAXEL | 1 | Intravenous (not otherwise specified) | 65 MG/M2, ON DAY 1 AND EACH CYCLE WAS REPEATED EVERY 21 DAYS | U | U | 0 | 65 | MG/M**2 | ||||||
| 125302131 | 12530213 | 8 | SS | DOCETAXEL. | DOCETAXEL | 1 | U | U | 0 | ||||||||||
| 125302131 | 12530213 | 9 | SS | DOCETAXEL. | DOCETAXEL | 1 | U | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125302131 | 12530213 | 1 | Ovarian cancer |
| 125302131 | 12530213 | 2 | Fallopian tube cancer |
| 125302131 | 12530213 | 3 | Malignant peritoneal neoplasm |
| 125302131 | 12530213 | 4 | Ovarian cancer |
| 125302131 | 12530213 | 5 | Fallopian tube cancer |
| 125302131 | 12530213 | 6 | Malignant peritoneal neoplasm |
| 125302131 | 12530213 | 7 | Ovarian cancer |
| 125302131 | 12530213 | 8 | Fallopian tube cancer |
| 125302131 | 12530213 | 9 | Malignant peritoneal neoplasm |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125302131 | 12530213 | HO |
| 125302131 | 12530213 | OT |
| 125302131 | 12530213 | DE |
| 125302131 | 12530213 | CA |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125302131 | 12530213 | Dehydration | |
| 125302131 | 12530213 | Diarrhoea | |
| 125302131 | 12530213 | Hypocalcaemia | |
| 125302131 | 12530213 | Hypotension | |
| 125302131 | 12530213 | Nausea | |
| 125302131 | 12530213 | Pancytopenia | |
| 125302131 | 12530213 | Respiratory arrest | |
| 125302131 | 12530213 | Sepsis | |
| 125302131 | 12530213 | Vomiting |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |