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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126788503 | 12678850 | 3 | F | 201608 | 20160907 | 20160824 | 20160912 | EXP | IT-ROCHE-1815584 | ROCHE | 36.00 | YR | F | Y | 0.00000 | 20160912 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126788503 | 12678850 | 1 | PS | PERJETA | PERTUZUMAB | 1 | Unknown | CONCENTRARE FOR SOLUTION FOR INTRAVENOUS?INFUSION | U | 125409 | |||||||||
| 126788503 | 12678850 | 2 | SS | HERCEPTIN | TRASTUZUMAB | 1 | Intravenous (not otherwise specified) | CONCENTRARE FOR SOLUTION FOR INTRAVENOUS?INFUSION | U | 103792 | |||||||||
| 126788503 | 12678850 | 3 | SS | PACLITAXEL. | PACLITAXEL | 1 | Intravenous (not otherwise specified) | CONCENTRARE FOR SOLUTION FOR INTRAVENOUS?INFUSION | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126788503 | 12678850 | 1 | HER-2 positive breast cancer |
| 126788503 | 12678850 | 2 | HER-2 positive breast cancer |
| 126788503 | 12678850 | 3 | HER-2 positive breast cancer |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126788503 | 12678850 | HO |
| 126788503 | 12678850 | LT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126788503 | 12678850 | Chills | |
| 126788503 | 12678850 | Dyspnoea | |
| 126788503 | 12678850 | Headache | |
| 126788503 | 12678850 | Hypersensitivity | |
| 126788503 | 12678850 | Lung infiltration | |
| 126788503 | 12678850 | Pyrexia | |
| 126788503 | 12678850 | Respiratory distress | |
| 126788503 | 12678850 | Sinus pain |
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 |
|---|---|---|---|---|---|---|
| 126788503 | 12678850 | 1 | 20160620 | 0 | ||
| 126788503 | 12678850 | 2 | 20160620 | 0 | ||
| 126788503 | 12678850 | 3 | 20160627 | 0 |