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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123151122 | 12315112 | 2 | F | 20160301 | 20160812 | 20160428 | 20160817 | EXP | US-ROCHE-1743744 | ROCHE | 61.00 | YR | F | Y | 82.70000 | KG | 20160817 | MD | US | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123151122 | 12315112 | 1 | PS | Trastuzumab | TRASTUZUMAB | 1 | Intravenous drip | LOADING DOSE?OVER 90 MIN ON DAY 1 OF CYCLE 1 | 1148016,1149499 | 103792 | 8 | MG/KG | SOLUTION FOR INFUSION | 1X | |||||
| 123151122 | 12315112 | 2 | SS | Trastuzumab | TRASTUZUMAB | 1 | Intravenous drip | 6 MG/KG X 95.3 KG, OVER 30-60 MIN ON DAY 1 (MAINTAINANCE DOSE)?LAST DOSE ADMNISTERATION DATE 23/FEB/ | 1148016,1149499 | 103792 | 6 | MG/KG | SOLUTION FOR INFUSION | Q3W | |||||
| 123151122 | 12315112 | 3 | SS | Pertuzumab | PERTUZUMAB | 1 | Intravenous drip | LOADING DOSE?OVER 60 MIN ON DAY 1 OF CYCLE 1 | 1150227,1151083 | 125409 | 840 | MG | SOLUTION FOR INFUSION | 1X | |||||
| 123151122 | 12315112 | 4 | SS | Pertuzumab | PERTUZUMAB | 1 | Intravenous drip | LAST DOSE ADMNISTERATION DATE 23/FEB/2016?TOTAL DOSE ADMINISTERED AT LAST INFUSION 420 MG?OVER 30-60 | 1150227,1151083 | 125409 | 420 | MG | SOLUTION FOR INFUSION | /wk | |||||
| 123151122 | 12315112 | 5 | SS | DOCETAXEL. | DOCETAXEL | 1 | Intravenous (not otherwise specified) | LAST DOSE ADMNISTERATION DATE 23/FEB/2016?TOTAL DOSE ADMINISTERED AT LAST ADMINISTRATION 161MG?75 MG | 0 | Q3W | |||||||||
| 123151122 | 12315112 | 6 | SS | CARBOPLATIN. | CARBOPLATIN | 1 | Intravenous (not otherwise specified) | AUC=6 MG/ML/MIN IV OVER 30-60 MIN ON DAY 1 OF EVERY CYCLE?LAST DOSE ADMNISTERATION DATE 23/FEB/2016 | 0 | Q3W |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123151122 | 12315112 | 1 | Invasive breast carcinoma |
| 123151122 | 12315112 | 3 | Invasive breast carcinoma |
| 123151122 | 12315112 | 5 | Invasive breast carcinoma |
| 123151122 | 12315112 | 6 | Invasive breast carcinoma |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123151122 | 12315112 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123151122 | 12315112 | Anaemia | |
| 123151122 | 12315112 | Colitis | |
| 123151122 | 12315112 | Dehydration | |
| 123151122 | 12315112 | Hypocalcaemia | |
| 123151122 | 12315112 | Mucosal infection | |
| 123151122 | 12315112 | Nausea | |
| 123151122 | 12315112 | Urinary tract infection |
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 |
|---|---|---|---|---|---|---|
| 123151122 | 12315112 | 1 | 20160107 | 20160504 | 0 | |
| 123151122 | 12315112 | 2 | 20160128 | 0 | ||
| 123151122 | 12315112 | 3 | 20160107 | 20160504 | 0 | |
| 123151122 | 12315112 | 4 | 20160128 | 0 | ||
| 123151122 | 12315112 | 5 | 20160107 | 20160504 | 0 | |
| 123151122 | 12315112 | 6 | 20160107 | 20160504 | 0 |