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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125524181 | 12552418 | 1 | I | 20160628 | 20160713 | 20160713 | EXP | JP-CIPLA LTD.-2016JP09415 | CIPLA | OKUSAKA T, IKEDA M, FUKUTOMI A, KOBAYASHI Y, SHIBAYAMA K, TAKUBO T ET AL.. SAFETY, TOLERABILITY, PHARMACOKINETICS AND ANTITUMOR ACTIVITY OF GANITUMAB, AN INVESTIGATIONAL FULLY HUMAN MONOCLONAL ANTIBODY TO INSULIN-LIKE GROWTH FACTOR TYPE 1 RECEPTOR, COMBINED WITH GEMCITABINE AS FIRST-LINE THERAPY IN PATIENTS WITH METASTATIC PANCREATIC CANCER: A PHASE 1B STUDY. JAPANESE JOURNAL OF CLINICAL ONCOLOGY. 2014;44 (5):442 TO 447 | 0.00 | Y | 0.00000 | 20160713 | OT | JP | JP |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125524181 | 12552418 | 1 | PS | GEMCITABINE | GEMCITABINEGEMCITABINE HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | 1000 MG/M2,ON DAYS 1, 8 AND 15 | U | 78759 | 1000 | MG/M**2 | INJECTION | ||||||
| 125524181 | 12552418 | 2 | SS | Ganitumab | GANITUMAB | 1 | Intravenous (not otherwise specified) | 20 MG/KG,ON DAYS 1 AND 15 OF EACH 28-DAY CYCLE | U | 0 | 20 | MG/KG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125524181 | 12552418 | 1 | Pancreatic carcinoma metastatic |
| 125524181 | 12552418 | 2 | Pancreatic carcinoma metastatic |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125524181 | 12552418 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125524181 | 12552418 | Disease progression | |
| 125524181 | 12552418 | Leukopenia | |
| 125524181 | 12552418 | Thrombocytopenia |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |