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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 120802563 | 12080256 | 3 | F | 20110421 | 20160830 | 20160216 | 20160913 | EXP | FR-SA-2016SA027264 | AVENTIS | 56.00 | YR | A | F | Y | 83.00000 | KG | 20160913 | LW | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 120802563 | 12080256 | 1 | PS | TAXOTERE | DOCETAXEL | 1 | Intravenous (not otherwise specified) | UNKNOWN | 20449 | 1 | DF | INJECTION | /cycle | ||||||
| 120802563 | 12080256 | 2 | SS | PACLITAXEL. | PACLITAXEL | 1 | FORM AND ROUTE- INTRAVENOUS INFUSION | UNKNOWN | 0 | 1 | DF | /cycle | |||||||
| 120802563 | 12080256 | 3 | SS | PACLITAXEL. | PACLITAXEL | 1 | FORM AND ROUTE- INTRAVENOUS INFUSION | UNKNOWN | 0 | 1 | DF | /cycle | |||||||
| 120802563 | 12080256 | 4 | SS | PACLITAXEL. | PACLITAXEL | 1 | FORM AND ROUTE- INTRAVENOUS INFUSION | UNKNOWN | 0 | 1 | DF | /cycle | |||||||
| 120802563 | 12080256 | 5 | SS | PACLITAXEL. | PACLITAXEL | 1 | FORM AND ROUTE- INTRAVENOUS INFUSION | UNKNOWN | 0 | 1 | DF | /cycle | |||||||
| 120802563 | 12080256 | 6 | SS | PACLITAXEL. | PACLITAXEL | 1 | FORM AND ROUTE- INTRAVENOUS INFUSION | UNKNOWN | 0 | 1 | DF | /cycle | |||||||
| 120802563 | 12080256 | 7 | SS | PACLITAXEL. | PACLITAXEL | 1 | FORM AND ROUTE- INTRAVENOUS INFUSION | UNKNOWN | 0 | 1 | DF | /cycle | |||||||
| 120802563 | 12080256 | 8 | SS | ENDOXAN | CYCLOPHOSPHAMIDE | 1 | FORM AND ROUTE- INTRAVENOUS INFUSION | UNKNOWN | 0 | 1 | DF | /cycle | |||||||
| 120802563 | 12080256 | 9 | SS | ENDOXAN | CYCLOPHOSPHAMIDE | 1 | FORM AND ROUTE- INTRAVENOUS INFUSION | UNKNOWN | 0 | 1 | DF | /cycle | |||||||
| 120802563 | 12080256 | 10 | SS | ENDOXAN | CYCLOPHOSPHAMIDE | 1 | FORM AND ROUTE- INTRAVENOUS INFUSION | UNKNOWN | 0 | 1 | DF | /cycle | |||||||
| 120802563 | 12080256 | 11 | SS | ENDOXAN | CYCLOPHOSPHAMIDE | 1 | FORM AND ROUTE- INTRAVENOUS INFUSION | UNKNOWN | 0 | 1 | DF | /cycle | |||||||
| 120802563 | 12080256 | 12 | SS | ENDOXAN | CYCLOPHOSPHAMIDE | 1 | FORM AND ROUTE- INTRAVENOUS INFUSION | UNKNOWN | 0 | 1 | DF | /cycle | |||||||
| 120802563 | 12080256 | 13 | SS | ENDOXAN | CYCLOPHOSPHAMIDE | 1 | FORM AND ROUTE- INTRAVENOUS INFUSION | UNKNOWN | 0 | 1 | DF | /cycle | |||||||
| 120802563 | 12080256 | 14 | SS | ENDOXAN | CYCLOPHOSPHAMIDE | 1 | FORM AND ROUTE- INTRAVENOUS INFUSION | UNKNOWN | 0 | 1 | DF | /cycle | |||||||
| 120802563 | 12080256 | 15 | SS | FEMARA | LETROZOLE | 1 | Oral | UNKNOWN | 0 | 2.5 | MG | FILM-COATED TABLET | QD | ||||||
| 120802563 | 12080256 | 16 | SS | AROMASIN | EXEMESTANE | 1 | Unknown | UNKNOWN | 0 | 25 | MG | TABLET | QD | ||||||
| 120802563 | 12080256 | 17 | SS | TAMOXIFEN | TAMOXIFEN | 1 | Oral | UNKNOWN | 0 | ||||||||||
| 120802563 | 12080256 | 18 | C | AUGMENTIN | AMOXICILLINCLAVULANATE POTASSIUM | 1 | Unknown | 0 | 1 | G | TID | ||||||||
| 120802563 | 12080256 | 19 | C | FEMARA | LETROZOLE | 1 | Oral | 0 | |||||||||||
| 120802563 | 12080256 | 20 | C | TAMOXIFEN | TAMOXIFEN | 1 | Oral | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 120802563 | 12080256 | 1 | Breast cancer |
| 120802563 | 12080256 | 2 | Breast cancer |
| 120802563 | 12080256 | 3 | Breast cancer |
| 120802563 | 12080256 | 4 | Breast cancer |
| 120802563 | 12080256 | 5 | Breast cancer |
| 120802563 | 12080256 | 6 | Breast cancer |
| 120802563 | 12080256 | 7 | Breast cancer |
| 120802563 | 12080256 | 8 | Breast cancer |
| 120802563 | 12080256 | 9 | Breast cancer |
| 120802563 | 12080256 | 10 | Breast cancer |
| 120802563 | 12080256 | 11 | Breast cancer |
| 120802563 | 12080256 | 12 | Breast cancer |
| 120802563 | 12080256 | 13 | Breast cancer |
| 120802563 | 12080256 | 14 | Breast cancer |
| 120802563 | 12080256 | 15 | Breast cancer |
| 120802563 | 12080256 | 16 | Breast cancer |
| 120802563 | 12080256 | 18 | Infection |
| 120802563 | 12080256 | 19 | Breast cancer |
| 120802563 | 12080256 | 20 | Breast cancer |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 120802563 | 12080256 | LT |
| 120802563 | 12080256 | HO |
| 120802563 | 12080256 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 120802563 | 12080256 | Bone pain | |
| 120802563 | 12080256 | Chronic myelomonocytic leukaemia | |
| 120802563 | 12080256 | Diarrhoea | |
| 120802563 | 12080256 | Skin toxicity | |
| 120802563 | 12080256 | Toxic skin eruption |
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 |
|---|---|---|---|---|---|---|
| 120802563 | 12080256 | 1 | 20110421 | 20110421 | 0 | |
| 120802563 | 12080256 | 2 | 20110512 | 20110512 | 0 | |
| 120802563 | 12080256 | 3 | 20110519 | 20110519 | 0 | |
| 120802563 | 12080256 | 4 | 20110526 | 20110526 | 0 | |
| 120802563 | 12080256 | 5 | 20110603 | 20110603 | 0 | |
| 120802563 | 12080256 | 6 | 20110609 | 20110609 | 0 | |
| 120802563 | 12080256 | 7 | 20110616 | 20110616 | 0 | |
| 120802563 | 12080256 | 8 | 20110421 | 20110616 | 0 | |
| 120802563 | 12080256 | 9 | 20110512 | 20110512 | 0 | |
| 120802563 | 12080256 | 10 | 20110519 | 20110519 | 0 | |
| 120802563 | 12080256 | 11 | 20110526 | 20110526 | 0 | |
| 120802563 | 12080256 | 12 | 20110603 | 20110603 | 0 | |
| 120802563 | 12080256 | 13 | 20110609 | 20110609 | 0 | |
| 120802563 | 12080256 | 14 | 20110616 | 20110616 | 0 | |
| 120802563 | 12080256 | 15 | 20110829 | 20111027 | 0 | |
| 120802563 | 12080256 | 16 | 20111115 | 20120403 | 0 | |
| 120802563 | 12080256 | 17 | 20120410 | 20130910 | 0 | |
| 120802563 | 12080256 | 18 | 20110623 | 20110630 | 0 | |
| 120802563 | 12080256 | 19 | 20110829 | 20111027 | 0 | |
| 120802563 | 12080256 | 20 | 2011 | 201109 | 0 |