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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125353991 | 12535399 | 1 | I | 200612 | 20120320 | 20160707 | 20160707 | EXP | US-CIPLA LTD.-2012US00362 | CIPLA | ANDREA STEBEL. REDUCTION IN CIRCULATING TUMOR CELL COUNT FOLLOWING THERAPY WITH NAB?-PACLITAXEL PLUS CARBOPLATIN IN A PATIENT WITH LEPTOMENINGEAL CARCINOMATOSIS FROM BREAST CANCER. ONCOLOGY. 2012;5:56 TO 61 | 0.00 | Y | 0.00000 | 20160707 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125353991 | 12535399 | 1 | PS | CARBOPLATIN. | CARBOPLATIN | 1 | AUC6 ON DAY 1 WEEKLY FOR 3 WEEKS OF A 4-WEEK CYCLE | Y | U | 77383 | INFUSION | ||||||||
| 125353991 | 12535399 | 2 | SS | PACLITAXEL. | PACLITAXEL | 1 | Unknown | 100 MG/M2, UNK | Y | U | 0 | 100 | MG/M**2 | INFUSION | |||||
| 125353991 | 12535399 | 3 | SS | PACLITAXEL. | PACLITAXEL | 1 | 100 MG/M2, WEEKLY | Y | U | 0 | 100 | MG/M**2 | INFUSION | ||||||
| 125353991 | 12535399 | 4 | SS | DOCETAXEL. | DOCETAXEL | 1 | Unknown | 100 MG/M2, | Y | U | 0 | 100 | MG/M**2 | ||||||
| 125353991 | 12535399 | 5 | C | ADRIAMYCIN | DOXORUBICIN HYDROCHLORIDE | 1 | Unknown | UNK | U | U | 0 | ||||||||
| 125353991 | 12535399 | 6 | C | CYTOXAN | CYCLOPHOSPHAMIDE | 1 | Unknown | UNK | U | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125353991 | 12535399 | 1 | Metastases to meninges |
| 125353991 | 12535399 | 2 | Metastases to meninges |
| 125353991 | 12535399 | 4 | Breast cancer |
| 125353991 | 12535399 | 5 | Breast cancer |
| 125353991 | 12535399 | 6 | Breast cancer |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125353991 | 12535399 | DE |
| 125353991 | 12535399 | HO |
| 125353991 | 12535399 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125353991 | 12535399 | Abasia | |
| 125353991 | 12535399 | Anaemia | |
| 125353991 | 12535399 | Gait disturbance | |
| 125353991 | 12535399 | Hydrocephalus | |
| 125353991 | 12535399 | Incontinence | |
| 125353991 | 12535399 | Metastases to meninges | |
| 125353991 | 12535399 | Metastatic neoplasm | |
| 125353991 | 12535399 | Neuropathy peripheral | |
| 125353991 | 12535399 | Neutropenia | |
| 125353991 | 12535399 | Urosepsis |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| Event ID | CASEID | DSG DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|---|
| 125353991 | 12535399 | 2 | 200607 | 0 | ||
| 125353991 | 12535399 | 3 | 200701 | 0 | ||
| 125353991 | 12535399 | 5 | 200606 | 0 | ||
| 125353991 | 12535399 | 6 | 200606 | 0 |