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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126772711 | 12677271 | 1 | I | 20160816 | 20160823 | 20160823 | EXP | US-JNJFOC-20160815542 | JANSSEN | TAP WD, JONES RL, VAN TINE BA, CHMIELOWSKI B, D ELIAS A, ADKINS D, ET AL. OLARATUMAB AND DOXORUBICIN VERSUS DOXORUBICIN ALONE FOR TREATMENT OF SOFT-TISSUE SARCOMA: AN OPEN LABEL PHASE 1B AND RANDOMISED PHASE 2 TRIAL. LANCET 30-JUL-2016;388/10043:488-497. | 0.00 | Y | 0.00000 | 20160823 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126772711 | 12677271 | 1 | PS | DOXORUBICIN HYDROCHLORIDE. | DOXORUBICIN HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | ON DAY 1 OF EACH 21-DAY CYCLE | U | U | 50718 | 75 | MG/M**2 | LIPOSOME INJECTION | |||||
| 126772711 | 12677271 | 2 | SS | OLARATUMAB | OLARATUMAB | 1 | Unknown | ON DAY 1 AND DAY 8 | U | 0 | 15 | MG/KG | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126772711 | 12677271 | 1 | Sarcoma metastatic |
| 126772711 | 12677271 | 2 | Sarcoma metastatic |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126772711 | 12677271 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126772711 | 12677271 | Abdominal pain | |
| 126772711 | 12677271 | Adverse event | |
| 126772711 | 12677271 | Alopecia | |
| 126772711 | 12677271 | Anaemia | |
| 126772711 | 12677271 | Cardiac disorder | |
| 126772711 | 12677271 | Constipation | |
| 126772711 | 12677271 | Decreased appetite | |
| 126772711 | 12677271 | Diarrhoea | |
| 126772711 | 12677271 | Ejection fraction decreased | |
| 126772711 | 12677271 | Fatigue | |
| 126772711 | 12677271 | Febrile neutropenia | |
| 126772711 | 12677271 | Infection | |
| 126772711 | 12677271 | Leukopenia | |
| 126772711 | 12677271 | Mucosal inflammation | |
| 126772711 | 12677271 | Musculoskeletal pain | |
| 126772711 | 12677271 | Nausea | |
| 126772711 | 12677271 | Neutropenia | |
| 126772711 | 12677271 | Oedema peripheral | |
| 126772711 | 12677271 | Pyrexia | |
| 126772711 | 12677271 | Thrombocytopenia | |
| 126772711 | 12677271 | Vomiting |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |