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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 93044453 | 9304445 | 3 | F | 20160822 | 20130522 | 20160829 | EXP | JP-ROCHE-1226112 | ROCHE | , NISHIKAWA K, NOSHIRO H, TSUBURAYA A, NISHIDA Y, YAMADA Y, MIWA H, SAKAI Y, YOSHIDA K, KODERA Y, BOKU N, MORITA S, SAKAMOTO J, SAJI S AND KITAGAWA Y. EFFICACY AND SAFETY OF TRASTUZUMAB (T-MAB) AND PACLITAXEL FOR T-MAB NAIVE PATIENTS WITH HER2 POSITIVE PREVIOUSLY TREATED METASTATIC GASTRIC CANCER (JFMC45-1102) (ABSTRACT 63). JOURNAL OF CLINICAL ONCOLOGY 2012;30 (SUP34):-. | 0.00 | Y | 0.00000 | 20160829 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 93044453 | 9304445 | 1 | PS | Trastuzumab | TRASTUZUMAB | 1 | Intravenous (not otherwise specified) | INITIAL DOSE | 103792 | 8 | MG/KG | SOLUTION FOR INFUSION | |||||||
| 93044453 | 9304445 | 2 | SS | Trastuzumab | TRASTUZUMAB | 1 | Intravenous (not otherwise specified) | 103792 | 6 | MG/KG | SOLUTION FOR INFUSION | Q3W | |||||||
| 93044453 | 9304445 | 3 | SS | PACLITAXEL. | PACLITAXEL | 1 | Intravenous (not otherwise specified) | DAYS 1, 8, AND, 15?OVER 60 MINUTES ONCE WEEKLY FOR 3 WEEKS FOLLOWED BY A 1 WEEK REST, REPEATED EVERY | U | 0 | 80 | MG/M**2 | INFUSION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 93044453 | 9304445 | 1 | Metastatic gastric cancer |
| 93044453 | 9304445 | 3 | Metastatic gastric cancer |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 93044453 | 9304445 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 93044453 | 9304445 | Alanine aminotransferase increased | |
| 93044453 | 9304445 | Altered state of consciousness | |
| 93044453 | 9304445 | Anaemia | |
| 93044453 | 9304445 | Aspartate aminotransferase increased | |
| 93044453 | 9304445 | Decreased appetite | |
| 93044453 | 9304445 | Fatigue | |
| 93044453 | 9304445 | Hypoalbuminaemia | |
| 93044453 | 9304445 | Hypokalaemia | |
| 93044453 | 9304445 | Hyponatraemia | |
| 93044453 | 9304445 | Leukopenia | |
| 93044453 | 9304445 | Neutropenia | |
| 93044453 | 9304445 | Peripheral sensory neuropathy | |
| 93044453 | 9304445 | Vomiting |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |