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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118719445 | 11871944 | 5 | F | 201511 | 20160427 | 20151228 | 20160728 | EXP | GB-ROCHE-1675688 | ROCHE | 59.64 | YR | F | Y | 0.00000 | 20160728 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118719445 | 11871944 | 1 | PS | Pertuzumab | PERTUZUMAB | 1 | Intravenous (not otherwise specified) | LOADING DOSE | 125409 | 840 | MG | SOLUTION FOR INFUSION | 1X | ||||||
| 118719445 | 11871944 | 2 | SS | Pertuzumab | PERTUZUMAB | 1 | Intravenous (not otherwise specified) | MAINTAINANCE DOSE | 125409 | 420 | MG | SOLUTION FOR INFUSION | Q3W | ||||||
| 118719445 | 11871944 | 3 | SS | Trastuzumab | TRASTUZUMAB | 1 | Intravenous (not otherwise specified) | LOADING DOSE: 8 MG/KG | 103792 | 609 | MG | SOLUTION FOR INFUSION | 1X | ||||||
| 118719445 | 11871944 | 4 | SS | Trastuzumab | TRASTUZUMAB | 1 | Intravenous (not otherwise specified) | MAINTAINANCE DOSE: 6 MG/KG | 103792 | 441 | MG | SOLUTION FOR INFUSION | Q3W | ||||||
| 118719445 | 11871944 | 5 | SS | DOCETAXEL. | DOCETAXEL | 1 | Intravenous (not otherwise specified) | NUMBER OF CYCLE PER REGIMEN 2 | 0 | 110 | MG | Q3W | |||||||
| 118719445 | 11871944 | 6 | SS | PACLITAXEL. | PACLITAXEL | 1 | Intravenous (not otherwise specified) | 0 | 150 | MG | /wk | ||||||||
| 118719445 | 11871944 | 7 | SS | PACLITAXEL. | PACLITAXEL | 1 | Intravenous (not otherwise specified) | 0 | 120 | MG | /wk | ||||||||
| 118719445 | 11871944 | 8 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | Oral | 0 | 20 | MG | CAPSULE | QD | |||||||
| 118719445 | 11871944 | 9 | C | PREGABALIN. | PREGABALIN | 1 | Oral | 0 | 75 | MG | TABLET | BID | |||||||
| 118719445 | 11871944 | 10 | C | MORPHINE | MORPHINE | 1 | Oral | MORPHINE MR | 0 | 30 | MG | CAPSULE | BID | ||||||
| 118719445 | 11871944 | 11 | C | CALCICHEW D3 | CALCIUMCHOLECALCIFEROL | 1 | Oral | 0 | 2 | DF | TABLET | QD | |||||||
| 118719445 | 11871944 | 12 | C | MIRTAZAPINE. | MIRTAZAPINE | 1 | Oral | 0 | 15 | MG | TABLET | QD | |||||||
| 118719445 | 11871944 | 13 | C | ORAMORPH | MORPHINE SULFATE | 1 | Oral | 0 | 10 | MG | |||||||||
| 118719445 | 11871944 | 14 | C | CO-AMOXICLAV | AMOXICILLINCLAVULANIC ACID | 1 | Oral | 0 | 625 | MG | TABLET | TID | |||||||
| 118719445 | 11871944 | 15 | C | LEVOFLOXACIN. | LEVOFLOXACIN | 1 | Oral | 0 | 500 | MG | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 118719445 | 11871944 | 1 | Breast cancer metastatic |
| 118719445 | 11871944 | 3 | Breast cancer metastatic |
| 118719445 | 11871944 | 5 | Breast cancer metastatic |
| 118719445 | 11871944 | 6 | Breast cancer metastatic |
| 118719445 | 11871944 | 8 | Dyspepsia |
| 118719445 | 11871944 | 14 | Febrile neutropenia |
| 118719445 | 11871944 | 15 | Febrile neutropenia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 118719445 | 11871944 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 118719445 | 11871944 | Alopecia | |
| 118719445 | 11871944 | Cellulitis | |
| 118719445 | 11871944 | Diarrhoea | |
| 118719445 | 11871944 | Dyspepsia | |
| 118719445 | 11871944 | Fatigue | |
| 118719445 | 11871944 | Mucosal inflammation | |
| 118719445 | 11871944 | Nasal discomfort | |
| 118719445 | 11871944 | Nausea | |
| 118719445 | 11871944 | Neuropathy peripheral |
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 |
|---|---|---|---|---|---|---|
| 118719445 | 11871944 | 1 | 20150930 | 20150930 | 0 | |
| 118719445 | 11871944 | 2 | 20151021 | 0 | ||
| 118719445 | 11871944 | 3 | 20150930 | 20150930 | 0 | |
| 118719445 | 11871944 | 4 | 20151021 | 0 | ||
| 118719445 | 11871944 | 5 | 20150930 | 20151021 | 0 | |
| 118719445 | 11871944 | 6 | 20151111 | 20151222 | 0 | |
| 118719445 | 11871944 | 7 | 20151223 | 0 | ||
| 118719445 | 11871944 | 8 | 201509 | 0 | ||
| 118719445 | 11871944 | 9 | 201509 | 0 | ||
| 118719445 | 11871944 | 10 | 201509 | 0 | ||
| 118719445 | 11871944 | 11 | 2011 | 0 | ||
| 118719445 | 11871944 | 12 | 201510 | 0 | ||
| 118719445 | 11871944 | 13 | 201509 | 0 | ||
| 118719445 | 11871944 | 14 | 20151121 | 20151125 | 0 | |
| 118719445 | 11871944 | 15 | 20151125 | 20151128 | 0 |