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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 115970302 | 11597030 | 2 | F | 20150624 | 20160810 | 20151006 | 20160824 | EXP | GB-ROCHE-1641219 | ROCHE | 72.85 | YR | F | Y | 0.00000 | 20160824 | MD | GB | GB |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 115970302 | 11597030 | 1 | PS | Trastuzumab Emtansine | ADO-TRASTUZUMAB EMTANSINE | 1 | Intravenous (not otherwise specified) | 125427 | 184 | MG | SOLUTION FOR INFUSION | Q3W | |||||||
| 115970302 | 11597030 | 2 | SS | Trastuzumab Emtansine | ADO-TRASTUZUMAB EMTANSINE | 1 | Intravenous (not otherwise specified) | 125427 | 148 | MG | SOLUTION FOR INFUSION | Q3W | |||||||
| 115970302 | 11597030 | 3 | SS | Pertuzumab | PERTUZUMAB | 1 | Intravenous (not otherwise specified) | Y | 125409 | 420 | MG | SOLUTION FOR INFUSION | Q3W | ||||||
| 115970302 | 11597030 | 4 | SS | Trastuzumab | TRASTUZUMAB | 1 | Intravenous (not otherwise specified) | LOADING DOSE | 103792 | 400 | MG | SOLUTION FOR INFUSION | Q3W | ||||||
| 115970302 | 11597030 | 5 | SS | Trastuzumab | TRASTUZUMAB | 1 | Intravenous (not otherwise specified) | 103792 | 300 | MG | SOLUTION FOR INFUSION | Q3W | |||||||
| 115970302 | 11597030 | 6 | SS | Trastuzumab | TRASTUZUMAB | 1 | Intravenous (not otherwise specified) | 103792 | 275 | MG | SOLUTION FOR INFUSION | Q3W | |||||||
| 115970302 | 11597030 | 7 | SS | Trastuzumab | TRASTUZUMAB | 1 | Intravenous (not otherwise specified) | 103792 | 300 | MG | SOLUTION FOR INFUSION | Q3W | |||||||
| 115970302 | 11597030 | 8 | SS | DOCETAXEL. | DOCETAXEL | 1 | Intravenous (not otherwise specified) | 0 | 92 | MG | SOLUTION FOR INFUSION | Q3W | |||||||
| 115970302 | 11597030 | 9 | SS | DOCETAXEL. | DOCETAXEL | 1 | Intravenous (not otherwise specified) | 0 | 86 | MG | SOLUTION FOR INFUSION | Q3W | |||||||
| 115970302 | 11597030 | 10 | C | DOMPERIDONE | DOMPERIDONE | 1 | Oral | 0 | 10 | MG | TABLET | TID | |||||||
| 115970302 | 11597030 | 11 | C | 3M CAVILON ANTIFUNGAL | MICONAZOLE NITRATE | 1 | Topical | 0 | 92 | G | CREAM | ||||||||
| 115970302 | 11597030 | 12 | C | CLAVULANIC ACID | CLAVULANIC ACID | 1 | Oral | 0 | 125 | MG | TABLET | TID | |||||||
| 115970302 | 11597030 | 13 | C | AMOXYCILLIN | AMOXICILLIN | 1 | Oral | 0 | 300 | MG | TABLET | TID | |||||||
| 115970302 | 11597030 | 14 | C | DEXAMETHASONE. | DEXAMETHASONE | 1 | Oral | THREE DAYS PRIOR TO CHEMOTHERAPY | 0 | 2 | MG | TABLET | BID | ||||||
| 115970302 | 11597030 | 15 | C | DEXAMETHASONE. | DEXAMETHASONE | 1 | Ophthalmic | LIQUID | 0 | 5 | ML | QID | |||||||
| 115970302 | 11597030 | 16 | C | RANITIDINE. | RANITIDINE | 1 | Oral | 0 | 150 | MG | TABLET | BID | |||||||
| 115970302 | 11597030 | 17 | C | CETIRIZINE | CETIRIZINE HYDROCHLORIDE | 1 | Oral | 0 | 10 | MG | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 115970302 | 11597030 | 1 | Breast cancer metastatic |
| 115970302 | 11597030 | 3 | Breast cancer metastatic |
| 115970302 | 11597030 | 4 | Breast cancer metastatic |
| 115970302 | 11597030 | 8 | HER-2 positive breast cancer |
| 115970302 | 11597030 | 10 | Prophylaxis |
| 115970302 | 11597030 | 11 | Prophylaxis |
| 115970302 | 11597030 | 12 | Infection |
| 115970302 | 11597030 | 13 | Infection |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 115970302 | 11597030 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 115970302 | 11597030 | Amnesia | |
| 115970302 | 11597030 | Anaphylactic reaction | |
| 115970302 | 11597030 | Axillary pain | |
| 115970302 | 11597030 | Catheter site haemorrhage | |
| 115970302 | 11597030 | Chest discomfort | |
| 115970302 | 11597030 | Constipation | |
| 115970302 | 11597030 | Dry skin | |
| 115970302 | 11597030 | Ejection fraction decreased | |
| 115970302 | 11597030 | Fatigue | |
| 115970302 | 11597030 | Lacrimation increased | |
| 115970302 | 11597030 | Memory impairment | |
| 115970302 | 11597030 | Nail dystrophy | |
| 115970302 | 11597030 | Neuropathy peripheral | |
| 115970302 | 11597030 | Pruritus |
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 |
|---|---|---|---|---|---|---|
| 115970302 | 11597030 | 1 | 20160426 | 20160720 | 0 | |
| 115970302 | 11597030 | 2 | 20160810 | 0 | ||
| 115970302 | 11597030 | 3 | 20150603 | 20150807 | 0 | |
| 115970302 | 11597030 | 4 | 20150513 | 20150513 | 0 | |
| 115970302 | 11597030 | 5 | 20150603 | 20150804 | 0 | |
| 115970302 | 11597030 | 6 | 20150818 | 0 | ||
| 115970302 | 11597030 | 7 | 20160108 | 20160405 | 0 | |
| 115970302 | 11597030 | 8 | 20150514 | 20150715 | 0 | |
| 115970302 | 11597030 | 9 | 20150828 | 0 | ||
| 115970302 | 11597030 | 10 | 20150803 | 20150805 | 0 | |
| 115970302 | 11597030 | 11 | 20150804 | 0 | ||
| 115970302 | 11597030 | 12 | 20150804 | 20150810 | 0 | |
| 115970302 | 11597030 | 13 | 20150804 | 20150810 | 0 | |
| 115970302 | 11597030 | 14 | 20150803 | 20150805 | 0 | |
| 115970302 | 11597030 | 15 | 20150714 | 20150923 | 0 | |
| 115970302 | 11597030 | 16 | 20150805 | 20150807 | 0 | |
| 115970302 | 11597030 | 17 | 20150805 | 20150807 | 0 |