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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 104219112 | 10421911 | 2 | F | 201009 | 20160810 | 20140901 | 20160825 | EXP | IT-CIPLA LTD.-2014IT01200 | CIPLA | ARPINO G, PLACIDO SD, ANGELIS CD. NAB-PACLITAXEL FOR THE MANAGEMENT OF TRIPLE-NEGATIVE METASTATIC BREAST CANCER: A CASE STUDY. ANTI-CANCER DRUGS. 2015;26:117 TO 126 | 0.00 | Y | 0.00000 | 20160825 | OT | IT | IT |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 104219112 | 10421911 | 1 | PS | Epirubicin | EPIRUBICIN | 1 | Unknown | UNK | 0 | ||||||||||
| 104219112 | 10421911 | 2 | SS | GEMCITABINE | GEMCITABINEGEMCITABINE HYDROCHLORIDE | 1 | Unknown | 1000 MG/M2, QW 2/3 | U | U | 0 | 1000 | MG/M**2 | ||||||
| 104219112 | 10421911 | 3 | SS | CARBOPLATIN. | CARBOPLATIN | 1 | Unknown | AUC5 ON DAY 1 Q3W | U | U | 0 | ||||||||
| 104219112 | 10421911 | 4 | SS | FLUOROURACIL. | FLUOROURACIL | 1 | Unknown | UNK | 0 | ||||||||||
| 104219112 | 10421911 | 5 | SS | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | Unknown | UNK | 0 | ||||||||||
| 104219112 | 10421911 | 6 | SS | VINORELBINE | VINORELBINEVINORELBINE TARTRATE | 1 | Unknown | UNK | U | U | 0 | ||||||||
| 104219112 | 10421911 | 7 | SS | PACLITAXEL. | PACLITAXEL | 1 | Unknown | 90 MG/M2 WEEKLY FOR 3 OF 4 WEEKS (QW 3/4)] | U | 0 | 90 | MG/M**2 | |||||||
| 104219112 | 10421911 | 8 | SS | PACLITAXEL. | PACLITAXEL | 1 | Unknown | 260 MG/M2, Q3W, SECOND-LINE | U | 0 | 260 | MG/M**2 | |||||||
| 104219112 | 10421911 | 9 | SS | Bevacizumab | BEVACIZUMAB | 1 | Unknown | 10 MG/KG EVERY 2 WEEKS (Q2W)] | 0 | 10 | MG/KG | ||||||||
| 104219112 | 10421911 | 10 | SS | Pegylated liposomal doxorubicin | DOXORUBICIN | 1 | Unknown | 50 MG/M2 EVERY 4 WEEKS | U | U | 0 | 50 | MG/M**2 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 104219112 | 10421911 | 1 | Breast cancer |
| 104219112 | 10421911 | 2 | Breast cancer metastatic |
| 104219112 | 10421911 | 3 | Breast cancer metastatic |
| 104219112 | 10421911 | 4 | Breast cancer |
| 104219112 | 10421911 | 5 | Breast cancer |
| 104219112 | 10421911 | 6 | Breast cancer metastatic |
| 104219112 | 10421911 | 7 | Breast cancer metastatic |
| 104219112 | 10421911 | 9 | Breast cancer metastatic |
| 104219112 | 10421911 | 10 | Breast cancer metastatic |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 104219112 | 10421911 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 104219112 | 10421911 | Disease progression | |
| 104219112 | 10421911 | Disease recurrence | |
| 104219112 | 10421911 | Drug ineffective | |
| 104219112 | 10421911 | Fatigue | |
| 104219112 | 10421911 | General physical health deterioration | |
| 104219112 | 10421911 | Neurotoxicity | |
| 104219112 | 10421911 | Peripheral sensory neuropathy |
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 |
|---|---|---|---|---|---|---|
| 104219112 | 10421911 | 1 | 200906 | 0 | ||
| 104219112 | 10421911 | 4 | 200906 | 0 | ||
| 104219112 | 10421911 | 5 | 200906 | 0 | ||
| 104219112 | 10421911 | 7 | 201003 | 201009 | 0 | |
| 104219112 | 10421911 | 9 | 201003 | 201104 | 0 |