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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125244681 | 12524468 | 1 | I | 20160621 | 20160704 | 20160704 | EXP | JP-CIPLA LTD.-2016JP08277 | CIPLA | NAGAO S, IWASA N, KUROSAKI A, NISHIKAWA T, OHISHI R, HASEGAWA K ET.AL. INTRAVENOUS/INTRAPERITONEAL PACLITAXEL AND INTRAPERITONEAL CARBOPLATIN IN PATIENTS WITH EPITHELIAL OVARIAN, FALLOPIAN TUBE, OR PERITONEAL CARCINOMA: A FEASIBILITY STUDY.. INT J GYNECOL CANCER. 2012;22:70 TO 75 | 0.00 | Y | 0.00000 | 20160704 | OT | JP | JP |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125244681 | 12524468 | 1 | PS | CARBOPLATIN. | CARBOPLATIN | 1 | Intraperitoneal | AUC = 6, 1000 ML OF SALINE WAS INFUSED THROUGH THE IP PORT | U | 77383 | |||||||||
| 125244681 | 12524468 | 2 | SS | CARBOPLATIN. | CARBOPLATIN | 1 | Intravenous (not otherwise specified) | AUC = 6 ON DAY 1, AS A BOLUS INFUSION | U | 77383 | |||||||||
| 125244681 | 12524468 | 3 | SS | PACLITAXEL. | PACLITAXEL | 1 | Intravenous (not otherwise specified) | 135 MG/M2, ON DAY 1 DILUTED IN 500 ML OF SALINE FOR 3 HOURS | U | 0 | 135 | MG/M**2 | INFUSION | ||||||
| 125244681 | 12524468 | 4 | SS | PACLITAXEL. | PACLITAXEL | 1 | Intraperitoneal | 45 OR 60 MG/M2, DILUTED IN 1000 ML OF SALINE FOR MORE THAN AN HOUR | U | 0 | INFUSION | ||||||||
| 125244681 | 12524468 | 5 | C | Ondansetron | ONDANSETRON | 1 | Unknown | UNK, ON DAYS 1 AND 8 | U | U | 0 | ||||||||
| 125244681 | 12524468 | 6 | C | Granisetron | GRANISETRON | 1 | Unknown | UNK, ON DAYS 1 AND 8 | U | U | 0 | ||||||||
| 125244681 | 12524468 | 7 | C | DEXAMETHASONE. | DEXAMETHASONE | 1 | Unknown | UNK, ON DAYS 1 AND 8 | U | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125244681 | 12524468 | 1 | Neoplasm malignant |
| 125244681 | 12524468 | 3 | Neoplasm malignant |
| 125244681 | 12524468 | 5 | Antiemetic supportive care |
| 125244681 | 12524468 | 6 | Antiemetic supportive care |
| 125244681 | 12524468 | 7 | Antiallergic therapy |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125244681 | 12524468 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125244681 | 12524468 | Disease progression |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |