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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125357701 | 12535770 | 1 | I | 20160312 | 20160701 | 20160707 | 20160707 | EXP | KR-ROCHE-1787920 | ROCHE | 0.00 | F | Y | 0.00000 | 20160707 | MD | KR | KR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125357701 | 12535770 | 1 | PS | Pertuzumab | PERTUZUMAB | 1 | Intravenous (not otherwise specified) | 125409 | 840 | MG | Q3W | ||||||||
| 125357701 | 12535770 | 2 | SS | Trastuzumab | TRASTUZUMAB | 1 | Intravenous (not otherwise specified) | 103792 | 8 | MG/KG | Q3W | ||||||||
| 125357701 | 12535770 | 3 | SS | DOCETAXEL. | DOCETAXEL | 1 | Intravenous (not otherwise specified) | 0 | 75 | MG/M**2 | Q3W | ||||||||
| 125357701 | 12535770 | 4 | C | SANCUSO | GRANISETRON | 1 | Unknown | PREMEDICATION FOR NAUSEA | 0 | 34.3 | MG | ||||||||
| 125357701 | 12535770 | 5 | C | DEXAMETHASONE. | DEXAMETHASONE | 1 | Intravenous (not otherwise specified) | PREMEDICATION FOR NEUROPATHY | 0 | 16 | MG | ||||||||
| 125357701 | 12535770 | 6 | C | SUSPEN ER | 2 | Oral | PREMEDICATION FOR NEURALGIA | 0 | 650 | MG | |||||||||
| 125357701 | 12535770 | 7 | C | CURAN | RANITIDINE HYDROCHLORIDE | 1 | Oral | PREVENTION FOR URTICARIA | 0 | 300 | MG | ||||||||
| 125357701 | 12535770 | 8 | C | NEURONTIN (SOUTH KOREA) | 2 | Oral | 0 | 900 | MG | ||||||||||
| 125357701 | 12535770 | 9 | C | TANTUM | BENZYDAMINE HYDROCHLORIDE | 1 | Other | PREVENTION OF STOMATITIS | 0 | 300 | ML | ||||||||
| 125357701 | 12535770 | 10 | C | NEOPLATIN (SOUTH KOREA) | 2 | Intravenous (not otherwise specified) | 0 | 450 | MG | ||||||||||
| 125357701 | 12535770 | 11 | C | NASERON | 2 | Intravenous (not otherwise specified) | PREMEDICATION FOR NAUSEA | 0 | .3 | MG | |||||||||
| 125357701 | 12535770 | 12 | C | KYTRIL | GRANISETRON HYDROCHLORIDE | 1 | Oral | PREVENTION FOR NAUSEA | 0 | 1 | MG | ||||||||
| 125357701 | 12535770 | 13 | C | LEUCOSTIM | FILGRASTIM | 1 | Intravenous (not otherwise specified) | 0 | 300 | UG | |||||||||
| 125357701 | 12535770 | 14 | C | LEUCOSTIM | FILGRASTIM | 1 | Intravenous (not otherwise specified) | 0 | 300 | UG | |||||||||
| 125357701 | 12535770 | 15 | C | LEUCOSTIM | FILGRASTIM | 1 | Intravenous (not otherwise specified) | 0 | 300 | UG | |||||||||
| 125357701 | 12535770 | 16 | C | MAXIPIME | CEFEPIME HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | PREVENTION OF INFECTION | 0 | 6000 | MG | ||||||||
| 125357701 | 12535770 | 17 | C | URSA | 2 | Oral | 0 | 600 | MG | ||||||||||
| 125357701 | 12535770 | 18 | C | URSA | 2 | 0 | |||||||||||||
| 125357701 | 12535770 | 19 | C | ONSERAN | 2 | Intravenous (not otherwise specified) | 0 | 4 | MG | ||||||||||
| 125357701 | 12535770 | 20 | C | EMEND | APREPITANT | 1 | Oral | 0 | 80 | MG | |||||||||
| 125357701 | 12535770 | 21 | C | SMECTA | MONTMORILLONITE | 1 | Oral | 0 | 60 | ML | |||||||||
| 125357701 | 12535770 | 22 | C | KETORAC | 2 | Intravenous (not otherwise specified) | 0 | 30 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125357701 | 12535770 | 1 | Breast cancer |
| 125357701 | 12535770 | 2 | Breast cancer |
| 125357701 | 12535770 | 3 | Breast cancer |
| 125357701 | 12535770 | 10 | Breast cancer |
| 125357701 | 12535770 | 13 | Neutropenia |
| 125357701 | 12535770 | 17 | Aspartate aminotransferase increased |
| 125357701 | 12535770 | 18 | Alanine aminotransferase increased |
| 125357701 | 12535770 | 19 | Nausea |
| 125357701 | 12535770 | 20 | Vomiting |
| 125357701 | 12535770 | 21 | Diarrhoea |
| 125357701 | 12535770 | 22 | Febrile neutropenia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125357701 | 12535770 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125357701 | 12535770 | Cholecystitis acute | |
| 125357701 | 12535770 | Febrile neutropenia |
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 |
|---|---|---|---|---|---|---|
| 125357701 | 12535770 | 1 | 20160304 | 0 | ||
| 125357701 | 12535770 | 2 | 20160304 | 0 | ||
| 125357701 | 12535770 | 3 | 20160304 | 0 | ||
| 125357701 | 12535770 | 4 | 20160303 | 0 | ||
| 125357701 | 12535770 | 5 | 20160303 | 0 | ||
| 125357701 | 12535770 | 6 | 20160304 | 0 | ||
| 125357701 | 12535770 | 7 | 20160304 | 0 | ||
| 125357701 | 12535770 | 8 | 20160304 | 0 | ||
| 125357701 | 12535770 | 9 | 20160304 | 0 | ||
| 125357701 | 12535770 | 10 | 20160304 | 0 | ||
| 125357701 | 12535770 | 11 | 20160304 | 0 | ||
| 125357701 | 12535770 | 12 | 20160305 | 0 | ||
| 125357701 | 12535770 | 13 | 20160605 | 20160606 | 0 | |
| 125357701 | 12535770 | 14 | 20160425 | 20160425 | 0 | |
| 125357701 | 12535770 | 15 | 20160626 | 20160627 | 0 | |
| 125357701 | 12535770 | 16 | 20160313 | 20160607 | 0 | |
| 125357701 | 12535770 | 17 | 20160425 | 0 | ||
| 125357701 | 12535770 | 19 | 20160514 | 0 | ||
| 125357701 | 12535770 | 20 | 20160605 | 20160607 | 0 | |
| 125357701 | 12535770 | 21 | 20160617 | 20160617 | 0 | |
| 125357701 | 12535770 | 22 | 20160304 | 20160516 | 0 |