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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 100235131 | 10023513 | 1 | I | 20110831 | 20131217 | 20131231 | 20131231 | EXP | 2011SA067532 | SANOFI | 0.00 | F | N | 43.00000 | KG | 20131230 | N | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 100235131 | 10023513 | 1 | PS | DOCETAXEL | 1 | INTRAVENOUS | D | D | 20449 | 600 | MG/M**2 | Q3W | |||||||
| 100235131 | 10023513 | 2 | SS | DOXORUBICIN | 1 | INTRAVENOUS | D | D | 0 | 600 | MG/M**2 | Q3W | |||||||
| 100235131 | 10023513 | 4 | SS | CYCLOPHOSPHAMIDE | 1 | INTRAVENOUS | D | D | 0 | 600 | MG/M**2 | Q3W | |||||||
| 100235131 | 10023513 | 5 | SS | TRASTUZUMAB | 1 | INTRAVENOUS | D | D | 0 | Q3W |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 100235131 | 10023513 | 1 | Breast cancer |
| 100235131 | 10023513 | 2 | Breast cancer |
| 100235131 | 10023513 | 4 | Breast cancer |
| 100235131 | 10023513 | 5 | Breast cancer |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 100235131 | 10023513 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 100235131 | 10023513 | Chronic myeloid leukaemia |
Reporting Sources (this data is often not reported and may therefore be missing here)
| Event ID | CASEID | RPSR COD |
|---|---|---|
| 100235131 | 10023513 | HP |
| 100235131 | 10023513 | SDY |
Therapies reported
| Event ID | CASEID | DSG DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|---|
| 100235131 | 10023513 | 1 | 20030605 | 20030605 | 0 | |
| 100235131 | 10023513 | 1 | 20030806 | 20030806 | 0 | |
| 100235131 | 10023513 | 2 | 20030312 | 20030312 | 0 | |
| 100235131 | 10023513 | 2 | 20030514 | 20030514 | 0 | |
| 100235131 | 10023513 | 4 | 20030312 | 20030514 | 0 | |
| 100235131 | 10023513 | 4 | 20030514 | 20030514 | 0 | |
| 100235131 | 10023513 | 5 | 20030605 | 20030605 | 0 | |
| 100235131 | 10023513 | 5 | 20030821 | 20030821 | 0 |