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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125515491 | 12551549 | 1 | I | 20160628 | 20160713 | 20160713 | EXP | US-CIPLA LTD.-2016US09397 | CIPLA | SPIGEL DR, HAINSWORTH JD, SHIPLEY DL, ERVIN TJ, KOHLER PC, LUBINER ET ET AL.,. A RANDOMIZED PHASE II TRIAL OF PEMETREXED/GEMCITABINE/BEVACIZUMAB OR PEMETREXED/CARBOPLATIN/BEVACIZUMAB IN THE FIRST-LINE TREATMENT OF ELDERLY PATIENTS WITH ADVANCED NON-SMALL CELL LUNG CANCER. JOURNAL OF THORACIC ONCOLOGY. 2012;7:196 TO 202 | 0.00 | Y | 0.00000 | 20160713 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125515491 | 12551549 | 1 | PS | CARBOPLATIN. | CARBOPLATIN | 1 | Intravenous (not otherwise specified) | AUC OF 5MG/ML/MIN ON DAY 1 OF 21-DAY CYCLE | U | U | 77383 | ||||||||
| 125515491 | 12551549 | 2 | SS | Pemetrexed | PEMETREXED | 1 | Intravenous (not otherwise specified) | 500 MG/M2 ON DAY 1 OF 21-DAY CYCLE | U | U | 0 | 500 | MG/M**2 | ||||||
| 125515491 | 12551549 | 3 | SS | Bevacizumab | BEVACIZUMAB | 1 | Intravenous (not otherwise specified) | 15 MG/KG,ON DAY 1 OF 21-DAY CYCLE | U | U | 0 | 15 | MG/KG | ||||||
| 125515491 | 12551549 | 4 | C | FOLIC ACID. | FOLIC ACID | 1 | Oral | 350 TO 1000 MICROGRAM DAILY | U | U | 0 | ||||||||
| 125515491 | 12551549 | 5 | C | VITAMIN B12 | CYANOCOBALAMIN | 1 | Intramuscular | 1000 ?G, EVERY 9 WEEKS | U | U | 0 | 1000 | UG | ||||||
| 125515491 | 12551549 | 6 | C | DEXAMETHASONE. | DEXAMETHASONE | 1 | Unknown | UNK | U | U | 0 | ||||||||
| 125515491 | 12551549 | 7 | C | LEUCOVORIN. | LEUCOVORIN | 1 | Unknown | UNK | U | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125515491 | 12551549 | 1 | Non-small cell lung cancer |
| 125515491 | 12551549 | 2 | Non-small cell lung cancer |
| 125515491 | 12551549 | 3 | Non-small cell lung cancer |
| 125515491 | 12551549 | 6 | Premedication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125515491 | 12551549 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125515491 | 12551549 | Dyspnoea |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |