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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124833825 | 12483382 | 5 | F | 20150916 | 20160906 | 20160621 | 20160909 | EXP | DE-ROCHE-1645577 | ROCHE | 64.00 | YR | F | Y | 105.00000 | KG | 20160909 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124833825 | 12483382 | 1 | PS | Pertuzumab | PERTUZUMAB | 1 | Intravenous (not otherwise specified) | LOADING DOSE | N | 125409 | 840 | MG | SOLUTION FOR INFUSION | ||||||
| 124833825 | 12483382 | 2 | SS | Pertuzumab | PERTUZUMAB | 1 | Intravenous (not otherwise specified) | N | 125409 | 420 | MG | SOLUTION FOR INFUSION | Q3W | ||||||
| 124833825 | 12483382 | 3 | SS | Trastuzumab | TRASTUZUMAB | 1 | Intravenous (not otherwise specified) | N | 103792 | 840 | MG | SOLUTION FOR INFUSION | |||||||
| 124833825 | 12483382 | 4 | SS | Trastuzumab | TRASTUZUMAB | 1 | Intravenous (not otherwise specified) | N | 103792 | 630 | MG | SOLUTION FOR INFUSION | Q3W | ||||||
| 124833825 | 12483382 | 5 | SS | Trastuzumab | TRASTUZUMAB | 1 | Intravenous (not otherwise specified) | N | 103792 | 600 | MG | SOLUTION FOR INFUSION | Q3W | ||||||
| 124833825 | 12483382 | 6 | SS | Trastuzumab | TRASTUZUMAB | 1 | Intravenous (not otherwise specified) | N | 103792 | 660 | MG | SOLUTION FOR INFUSION | Q3W | ||||||
| 124833825 | 12483382 | 7 | SS | Trastuzumab | TRASTUZUMAB | 1 | Intravenous (not otherwise specified) | N | 103792 | 690 | MG | SOLUTION FOR INFUSION | Q3W | ||||||
| 124833825 | 12483382 | 8 | SS | Trastuzumab | TRASTUZUMAB | 1 | Intravenous (not otherwise specified) | N | 103792 | 534 | MG | SOLUTION FOR INFUSION | Q3W | ||||||
| 124833825 | 12483382 | 9 | SS | Trastuzumab | TRASTUZUMAB | 1 | Intravenous (not otherwise specified) | N | 103792 | 468 | MG | SOLUTION FOR INFUSION | Q3W | ||||||
| 124833825 | 12483382 | 10 | SS | DOCETAXEL. | DOCETAXEL | 1 | Intravenous (not otherwise specified) | N | 0 | 150 | MG | Q3W | |||||||
| 124833825 | 12483382 | 11 | SS | DOCETAXEL. | DOCETAXEL | 1 | Intravenous (not otherwise specified) | N | 0 | 112.5 | MG | Q3W | |||||||
| 124833825 | 12483382 | 12 | C | BISOPROLOL | BISOPROLOL | 1 | Oral | 0 | 5 | MG | QD | ||||||||
| 124833825 | 12483382 | 13 | C | METHOTREXATE. | METHOTREXATE | 1 | Unknown | 0 | 15 | MG | /wk | ||||||||
| 124833825 | 12483382 | 14 | C | SULFASALAZINE DELAYED-RELEASE | SULFASALAZINE | 1 | Oral | 0 | 500 | MG | BID | ||||||||
| 124833825 | 12483382 | 15 | C | AMITRIPTYLIN | AMITRIPTYLINE | 1 | Oral | 0 | 25 | MG | QD | ||||||||
| 124833825 | 12483382 | 16 | C | PANTOPRAZOL | PANTOPRAZOLE SODIUM | 1 | Oral | 0 | 40 | MG | QD | ||||||||
| 124833825 | 12483382 | 17 | C | ALOXI | PALONOSETRON HYDROCHLORIDE | 1 | Oral | 0 | 500 | UG | |||||||||
| 124833825 | 12483382 | 18 | C | DEXAMETHASON | DEXAMETHASONE | 1 | Intravenous (not otherwise specified) | 0 | 20 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124833825 | 12483382 | 1 | HER-2 positive breast cancer |
| 124833825 | 12483382 | 3 | HER-2 positive breast cancer |
| 124833825 | 12483382 | 10 | Breast cancer |
| 124833825 | 12483382 | 12 | Hypertension |
| 124833825 | 12483382 | 13 | Arthropathy |
| 124833825 | 12483382 | 14 | Arthropathy |
| 124833825 | 12483382 | 15 | Arthropathy |
| 124833825 | 12483382 | 16 | Abdominal pain upper |
| 124833825 | 12483382 | 17 | Nausea |
| 124833825 | 12483382 | 18 | Nausea |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124833825 | 12483382 | OT |
| 124833825 | 12483382 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124833825 | 12483382 | Alopecia | |
| 124833825 | 12483382 | Ascites | |
| 124833825 | 12483382 | Constipation | |
| 124833825 | 12483382 | Decreased appetite | |
| 124833825 | 12483382 | Dyspnoea | |
| 124833825 | 12483382 | Intestinal haemorrhage | |
| 124833825 | 12483382 | Nail disorder | |
| 124833825 | 12483382 | Nausea | |
| 124833825 | 12483382 | Peripheral sensory neuropathy | |
| 124833825 | 12483382 | Pyrexia |
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 |
|---|---|---|---|---|---|---|
| 124833825 | 12483382 | 1 | 20150916 | 20150916 | 0 | |
| 124833825 | 12483382 | 2 | 20151007 | 0 | ||
| 124833825 | 12483382 | 3 | 20150916 | 20150916 | 0 | |
| 124833825 | 12483382 | 4 | 20151007 | 20151007 | 0 | |
| 124833825 | 12483382 | 5 | 20151028 | 20151216 | 0 | |
| 124833825 | 12483382 | 6 | 20160113 | 20160113 | 0 | |
| 124833825 | 12483382 | 7 | 20160208 | 20160208 | 0 | |
| 124833825 | 12483382 | 8 | 20160229 | 20160523 | 0 | |
| 124833825 | 12483382 | 9 | 20160613 | 0 | ||
| 124833825 | 12483382 | 10 | 20150916 | 20151028 | 0 | |
| 124833825 | 12483382 | 11 | 20151125 | 20151216 | 0 | |
| 124833825 | 12483382 | 12 | 20050701 | 0 | ||
| 124833825 | 12483382 | 13 | 20000701 | 0 | ||
| 124833825 | 12483382 | 14 | 20000701 | 0 | ||
| 124833825 | 12483382 | 15 | 20000701 | 0 | ||
| 124833825 | 12483382 | 16 | 2000 | 0 | ||
| 124833825 | 12483382 | 17 | 20150916 | 20151216 | 0 | |
| 124833825 | 12483382 | 18 | 20150916 | 20151216 | 0 |