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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1160848318 | 11608483 | 18 | F | 2015 | 20160630 | 20151007 | 20160706 | EXP | CA-ROCHE-1592804 | ROCHE | 62.00 | YR | F | Y | 76.50000 | KG | 20160706 | CN | CA | CA |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1160848318 | 11608483 | 1 | PS | PERJETA | PERTUZUMAB | 1 | Intravenous (not otherwise specified) | H0080801 | 125409 | 840 | MG | Q3W | |||||||
| 1160848318 | 11608483 | 2 | SS | PERJETA | PERTUZUMAB | 1 | Intravenous (not otherwise specified) | H0080801 | 125409 | 420 | MG | Q3W | |||||||
| 1160848318 | 11608483 | 3 | SS | HERCEPTIN | TRASTUZUMAB | 1 | Intravenous (not otherwise specified) | 103792 | |||||||||||
| 1160848318 | 11608483 | 4 | SS | TAXOL | PACLITAXEL | 1 | Unknown | 0 | |||||||||||
| 1160848318 | 11608483 | 5 | SS | VANCOMYCIN | VANCOMYCIN | 1 | Intravenous (not otherwise specified) | U | 0 | ||||||||||
| 1160848318 | 11608483 | 6 | SS | ZYVOXAM | LINEZOLID | 1 | Oral | 2 PILLS FOR 5 DAYS | U | 0 | 600 | MG | QD | ||||||
| 1160848318 | 11608483 | 7 | C | VITAMIN C | ASCORBIC ACID | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 1160848318 | 11608483 | 1 | HER-2 positive breast cancer |
| 1160848318 | 11608483 | 3 | HER-2 positive breast cancer |
| 1160848318 | 11608483 | 4 | HER-2 positive breast cancer |
| 1160848318 | 11608483 | 5 | Product used for unknown indication |
| 1160848318 | 11608483 | 6 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 1160848318 | 11608483 | OT |
| 1160848318 | 11608483 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 1160848318 | 11608483 | Abdominal distension | |
| 1160848318 | 11608483 | Abdominal pain upper | |
| 1160848318 | 11608483 | Alanine aminotransferase increased | |
| 1160848318 | 11608483 | Aspartate aminotransferase increased | |
| 1160848318 | 11608483 | Asthenia | |
| 1160848318 | 11608483 | Blood calcium decreased | |
| 1160848318 | 11608483 | Blood chloride decreased | |
| 1160848318 | 11608483 | Blood glucose increased | |
| 1160848318 | 11608483 | Blood lactate dehydrogenase increased | |
| 1160848318 | 11608483 | Blood magnesium decreased | |
| 1160848318 | 11608483 | Blood pressure increased | |
| 1160848318 | 11608483 | Carbohydrate antigen 15-3 increased | |
| 1160848318 | 11608483 | Cellulitis | |
| 1160848318 | 11608483 | Condition aggravated | |
| 1160848318 | 11608483 | Diarrhoea | |
| 1160848318 | 11608483 | Dysgeusia | |
| 1160848318 | 11608483 | Eczema | |
| 1160848318 | 11608483 | Fatigue | |
| 1160848318 | 11608483 | Gastritis | |
| 1160848318 | 11608483 | Haematocrit decreased | |
| 1160848318 | 11608483 | Haemoglobin decreased | |
| 1160848318 | 11608483 | Hypoaesthesia | |
| 1160848318 | 11608483 | Infusion site erythema | |
| 1160848318 | 11608483 | Lymphocyte count decreased | |
| 1160848318 | 11608483 | Mean cell haemoglobin increased | |
| 1160848318 | 11608483 | Mean cell volume increased | |
| 1160848318 | 11608483 | Mean platelet volume decreased | |
| 1160848318 | 11608483 | Monocyte count increased | |
| 1160848318 | 11608483 | Nail discolouration | |
| 1160848318 | 11608483 | Neuropathy peripheral | |
| 1160848318 | 11608483 | Neutrophil count decreased | |
| 1160848318 | 11608483 | Neutrophil count increased | |
| 1160848318 | 11608483 | Platelet count decreased | |
| 1160848318 | 11608483 | Pneumonia | |
| 1160848318 | 11608483 | Red blood cell count decreased | |
| 1160848318 | 11608483 | Red cell distribution width increased | |
| 1160848318 | 11608483 | Urinary tract infection | |
| 1160848318 | 11608483 | Weight decreased | |
| 1160848318 | 11608483 | White blood cell count decreased |
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 |
|---|---|---|---|---|---|---|
| 1160848318 | 11608483 | 1 | 20150615 | 0 | ||
| 1160848318 | 11608483 | 2 | 20150706 | 0 | ||
| 1160848318 | 11608483 | 3 | 20130323 | 0 | ||
| 1160848318 | 11608483 | 4 | 20150124 | 0 |