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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 105972914 | 10597291 | 4 | F | 20141022 | 20160830 | 20141121 | 20160902 | EXP | AU-ROCHE-1479807 | ROCHE | 74.37 | YR | F | Y | 79.00000 | KG | 20160902 | MD | AU | AU |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 105972914 | 10597291 | 1 | PS | Pertuzumab | PERTUZUMAB | 1 | Intravenous (not otherwise specified) | LOADING DOSE | Y | H0030B18,1133409 | 125409 | 840 | MG | SOLUTION FOR INFUSION | |||||
| 105972914 | 10597291 | 2 | SS | Pertuzumab | PERTUZUMAB | 1 | Intravenous (not otherwise specified) | LAST DOSE PRIOR TO SAE 08/OCT/2014?MAINTENANCE DOSE | Y | H0030B18,1133409 | 125409 | 420 | MG | SOLUTION FOR INFUSION | Q3W | ||||
| 105972914 | 10597291 | 3 | SS | Trastuzumab | TRASTUZUMAB | 1 | Subcutaneous | LAST DOSE PRIOR TO SAE 08/OCT/2014 | Y | 1133409,1146333 | 103792 | 600 | MG | SOLUTION FOR INJECTION | Q3W | ||||
| 105972914 | 10597291 | 4 | SS | NAB-PACLITAXEL | PACLITAXEL | 1 | Intravenous (not otherwise specified) | LAST DOSE PRIOR TO SAE 22/OCT/2014 | Y | 0 | 180 | MG | SOLUTION FOR INFUSION | /wk | |||||
| 105972914 | 10597291 | 5 | C | LORATADINE. | LORATADINE | 1 | Unknown | 0 | |||||||||||
| 105972914 | 10597291 | 6 | C | PANADEINE FORTE | ACETAMINOPHENCODEINE PHOSPHATE | 1 | Unknown | 0 | |||||||||||
| 105972914 | 10597291 | 7 | C | OXYCONTIN | OXYCODONE HYDROCHLORIDE | 1 | Unknown | 0 | |||||||||||
| 105972914 | 10597291 | 8 | C | ENDONE | OXYCODONE HYDROCHLORIDE | 1 | Unknown | 0 | |||||||||||
| 105972914 | 10597291 | 9 | C | SLOW K | POTASSIUM CHLORIDE | 1 | Oral | 0 | 2 | DF | TABLET | ||||||||
| 105972914 | 10597291 | 10 | C | COLOXYL WITH SENNA | DOCUSATESENNOSIDES | 1 | Oral | 0 | 4 | DF | TABLET | ||||||||
| 105972914 | 10597291 | 11 | C | PARACETAMOL | ACETAMINOPHEN | 1 | Unknown | 0 | |||||||||||
| 105972914 | 10597291 | 12 | C | MAGMIN | MAGNESIUM ASPARTATE | 1 | Oral | 0 | 4 | DF | TABLET | ||||||||
| 105972914 | 10597291 | 13 | C | CALTRATE | CALCIUM CARBONATE | 1 | Oral | 0 | TABLET | ||||||||||
| 105972914 | 10597291 | 14 | C | CALTRATE | CALCIUM CARBONATE | 1 | Unknown | 0 | |||||||||||
| 105972914 | 10597291 | 15 | C | CHOLECALCIFEROL | CHOLECALCIFEROL | 1 | Unknown | 0 | 70 | UG | |||||||||
| 105972914 | 10597291 | 16 | C | LASIX | FUROSEMIDE | 1 | Unknown | 20-40 MG | 0 | ||||||||||
| 105972914 | 10597291 | 17 | C | CLEXANE | ENOXAPARIN SODIUM | 1 | Unknown | 0 | 20 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 105972914 | 10597291 | 1 | HER-2 positive breast cancer |
| 105972914 | 10597291 | 3 | HER-2 positive breast cancer |
| 105972914 | 10597291 | 4 | HER-2 positive breast cancer |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 105972914 | 10597291 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 105972914 | 10597291 | Dermatitis bullous | |
| 105972914 | 10597291 | Vomiting |
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 |
|---|---|---|---|---|---|---|
| 105972914 | 10597291 | 1 | 20140716 | 20140716 | 0 | |
| 105972914 | 10597291 | 2 | 20140806 | 20141113 | 0 | |
| 105972914 | 10597291 | 3 | 20140717 | 20141112 | 0 | |
| 105972914 | 10597291 | 4 | 20140717 | 20141027 | 0 | |
| 105972914 | 10597291 | 5 | 20140731 | 0 | ||
| 105972914 | 10597291 | 6 | 20140731 | 0 | ||
| 105972914 | 10597291 | 7 | 20141008 | 0 | ||
| 105972914 | 10597291 | 8 | 20141008 | 0 | ||
| 105972914 | 10597291 | 9 | 20141025 | 0 | ||
| 105972914 | 10597291 | 10 | 20141025 | 0 | ||
| 105972914 | 10597291 | 11 | 20141026 | 0 | ||
| 105972914 | 10597291 | 12 | 20141028 | 0 | ||
| 105972914 | 10597291 | 13 | 20141029 | 0 | ||
| 105972914 | 10597291 | 14 | 20141210 | 20141212 | 0 | |
| 105972914 | 10597291 | 15 | 20141029 | 0 | ||
| 105972914 | 10597291 | 16 | 20141008 | 0 | ||
| 105972914 | 10597291 | 17 | 20141210 | 20141212 | 0 |