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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126950481 | 12695048 | 1 | I | 20160823 | 20160829 | 20160829 | EXP | GR-MYLANLABS-2016M1036442 | MYLAN | KONTOPODIS E, KOTSAKIS A, KENTEPOZIDIS N, SYRIGOS K, ZIRAS N, MOUTSOS M, ET AL. A PHASE II, OPEN-LABEL TRIAL OF BORTEZOMIB (VELCADE) IN COMBINATION WITH GEMCITABINE AND CISPLATIN IN PATIENTS WITH LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER. CANCER-CHEMOTHER-PHARMACOL 2016;77(5):949-956. | 0.00 | Y | 0.00000 | 20160829 | OT | GR | GR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126950481 | 12695048 | 1 | PS | GEMCITABINE | GEMCITABINEGEMCITABINE HYDROCHLORIDE | 1 | Unknown | 1000 MG/M2 ON DAYS 1 AND 8, REPEATED EVERY 21 DAYS | 200145 | ||||||||||
| 126950481 | 12695048 | 2 | SS | CISPLATIN. | CISPLATIN | 1 | Unknown | 70 MG/M2 ON DAY 1, REPEATED EVERY 21 DAYS | 0 | ||||||||||
| 126950481 | 12695048 | 3 | SS | VELCADE | BORTEZOMIB | 1 | Intravenous (not otherwise specified) | 1 MG/M2 ON DAYS 1 AND 8 OF 21 DAY TREATMENT CYCLE | U | 0 | |||||||||
| 126950481 | 12695048 | 4 | SS | VELCADE | BORTEZOMIB | 1 | Unknown | 1 MG/M2 ON DAYS 1 AND 8, REPEATED EVERY 21 DAYS | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126950481 | 12695048 | 1 | Non-small cell lung cancer |
| 126950481 | 12695048 | 2 | Non-small cell lung cancer |
| 126950481 | 12695048 | 3 | Non-small cell lung cancer |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126950481 | 12695048 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126950481 | 12695048 | Multiple organ dysfunction syndrome | |
| 126950481 | 12695048 | Sepsis |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |