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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 91787862 | 9178786 | 2 | F | 20160801 | 20130321 | 20160810 | EXP | GB-ROCHE-1203914 | ROCHE | , REA D, AHMED S, BECK J, LOPEZ R, BIGANZOLI L, ARMSTRONG A, AGLIETTA M, ALBA E, CAMPONE M, SCHMITZ S, LEFEBVRE C, AKIMOV M AND LEE S-C. PHASE 1B/2 STUDY OF THE HSP90 INHIBITOR AUY922 PLUS TRASTUZUMAB IN METASTATIC HER2-POSITIVE BREAST CANCER PATIENTS WHO HAVE PROGRESSED ON TRASTUZUMAB-BASED REGIMEN. ONCOTARGET 2016;7 (25):37680-37692. | 0.00 | F | Y | 0.00000 | 20160810 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 91787862 | 9178786 | 1 | PS | Trastuzumab | TRASTUZUMAB | 1 | Intravenous (not otherwise specified) | THE LICENSED WEEKLY DOSE OF 2 MG/KG OVER 30 MINUTES (OR 4 MG/KG OVER 90 MINUTES IF A LOADING DOSE WA | U | 103792 | SOLUTION FOR INFUSION | ||||||||
| 91787862 | 9178786 | 2 | SS | INVESTIGATIONAL ANTINEOPLASTIC AGENT | INVESTIGATIONAL PRODUCT | 1 | Intravenous (not otherwise specified) | 55 OR 70 MG/M2 IN A 28-DAY CYCLE | U | 0 | INFUSION | /wk |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 91787862 | 9178786 | 1 | HER-2 positive breast cancer |
| 91787862 | 9178786 | 2 | HER-2 positive breast cancer |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 91787862 | 9178786 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 91787862 | 9178786 | Accommodation disorder | |
| 91787862 | 9178786 | Asthenia | |
| 91787862 | 9178786 | Diarrhoea | |
| 91787862 | 9178786 | Ejection fraction decreased | |
| 91787862 | 9178786 | Fatigue | |
| 91787862 | 9178786 | Nausea | |
| 91787862 | 9178786 | Optic nerve disorder | |
| 91787862 | 9178786 | Visual impairment | |
| 91787862 | 9178786 | Vomiting |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |