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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123291522 | 12329152 | 2 | F | 20160421 | 20160914 | 20160503 | 20160920 | EXP | DE-ROCHE-1746835 | ROCHE | 65.00 | YR | F | Y | 55.00000 | KG | 20160920 | MD | DE | DE |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123291522 | 12329152 | 1 | PS | Pertuzumab | PERTUZUMAB | 1 | Intravenous (not otherwise specified) | LOADING DOSE AS PER PROTOCOL | 125409 | 840 | MG | SOLUTION FOR INFUSION | |||||||
| 123291522 | 12329152 | 2 | SS | Pertuzumab | PERTUZUMAB | 1 | Intravenous (not otherwise specified) | MAINTENANCE DOSE, ?LAST DOSE PRIOR TO SAE ON 06/APR/2016 | 125409 | 420 | MG | SOLUTION FOR INFUSION | Q3W | ||||||
| 123291522 | 12329152 | 3 | SS | Trastuzumab | TRASTUZUMAB | 1 | Intravenous (not otherwise specified) | LOADING DOSE AS PER PROTOCOL | 103792 | 8 | MG/KG | SOLUTION FOR INFUSION | |||||||
| 123291522 | 12329152 | 4 | SS | Trastuzumab | TRASTUZUMAB | 1 | Intravenous (not otherwise specified) | MAINTENANCE DOSE, LAST DOSE PRIOR TO SAE ON 06/APR/2016 | 103792 | 6 | MG/KG | SOLUTION FOR INFUSION | Q3W | ||||||
| 123291522 | 12329152 | 5 | SS | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | Intravenous (not otherwise specified) | LAST DOSE PRIOR TO SAE ON 18/MAY/2016?TEMPORARILY INTERRUPTED ON 21/APR/2016 | N | 0 | QOW | ||||||||
| 123291522 | 12329152 | 6 | SS | PACLITAXEL. | PACLITAXEL | 1 | Intravenous (not otherwise specified) | LAST DOSE PRIOR TO SAE ON 30/MAR/2016 | 0 | QOW | |||||||||
| 123291522 | 12329152 | 7 | SS | EPIRUBICIN | EPIRUBICIN | 1 | Intravenous (not otherwise specified) | LAST DOSE PRIOR TO SAE ON 03/FEB/2016 | 0 | QOW |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123291522 | 12329152 | 1 | HER-2 positive breast cancer |
| 123291522 | 12329152 | 3 | HER-2 positive breast cancer |
| 123291522 | 12329152 | 5 | HER-2 positive breast cancer |
| 123291522 | 12329152 | 6 | HER-2 positive breast cancer |
| 123291522 | 12329152 | 7 | HER-2 positive breast cancer |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123291522 | 12329152 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123291522 | 12329152 | Pancytopenia |
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 |
|---|---|---|---|---|---|---|
| 123291522 | 12329152 | 1 | 20160224 | 0 | ||
| 123291522 | 12329152 | 3 | 20160224 | 0 | ||
| 123291522 | 12329152 | 5 | 20160413 | 0 | ||
| 123291522 | 12329152 | 6 | 20160224 | 0 | ||
| 123291522 | 12329152 | 7 | 20151223 | 0 |