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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125349471 | 12534947 | 1 | I | 20160622 | 20160707 | 20160707 | EXP | FR-CIPLA LTD.-2016FR08443 | CIPLA | KURTZ JE, FREYER G, JOLY F, GLADIEFF L, KAMINSKI MC, FABBRO M, ET AL.. COMBINED ORAL TOPOTECAN PLUS CARBOPLATIN IN RELAPSED OR ADVANCED CERVICAL CANCER: A GINECO PHASE I-II TRIAL. ANTICANCER RESEARCH. 2012;32:1045 TO 1050 | 0.00 | Y | 0.00000 | 20160707 | OT | FR | FR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125349471 | 12534947 | 1 | PS | TOPOTECAN | TOPOTECANTOPOTECAN HYDROCHLORIDE | 1 | Oral | UNK | U | U | 91199 | ||||||||
| 125349471 | 12534947 | 2 | SS | CARBOPLATIN. | CARBOPLATIN | 1 | Unknown | UNK, PRIOR CHEMOTHERAPY | U | U | 0 | ||||||||
| 125349471 | 12534947 | 3 | SS | CARBOPLATIN. | CARBOPLATIN | 1 | Intravenous (not otherwise specified) | AUC-5, ON DAY 1, EVERY 3 WEEKS | U | U | 0 | ||||||||
| 125349471 | 12534947 | 4 | SS | CISPLATIN. | CISPLATIN | 1 | Unknown | UNK, PRIOR CHEMOTHERAPY | U | U | 0 | ||||||||
| 125349471 | 12534947 | 5 | SS | PACLITAXEL. | PACLITAXEL | 1 | Unknown | UNK, PRIOR CHEMOTHERAPY | U | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125349471 | 12534947 | 1 | Cervix carcinoma |
| 125349471 | 12534947 | 2 | Cervix carcinoma |
| 125349471 | 12534947 | 4 | Cervix carcinoma |
| 125349471 | 12534947 | 5 | Cervix carcinoma |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125349471 | 12534947 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125349471 | 12534947 | Disease progression |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |