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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
125385881 | 12538588 | 1 | I | 20160623 | 20160708 | 20160708 | EXP | US-CIPLA LTD.-2016US09079 | CIPLA | SOCINSKI MA, STINCHCOMBE TE, MOORE DT, GETTINGER SN , DECKER RH, PETTY WJ ET AL.,. INCORPORATING BEVACIZUMAB AND ERLOTINIB IN THE COMBINED-MODALITY TREATMENT OF STAGE III NON-SMALL-CELL LUNG CANCER: RESULTS OF A PHASE I/II TRIAL. JOURNAL OF CLINICAL ONCOLOGY. 2012;30(32):3953 TO 3959 | 0.00 | Y | 0.00000 | 20160708 | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
125385881 | 12538588 | 1 | PS | CARBOPLATIN. | CARBOPLATIN | 1 | Intravenous (not otherwise specified) | AUC 6 ON DAYS 1 AND 22 | U | U | 77383 | INFUSION | |||||||
125385881 | 12538588 | 2 | SS | CARBOPLATIN. | CARBOPLATIN | 1 | Intravenous (not otherwise specified) | AUC 2 ON DAY 43 | U | U | 77383 | INFUSION | |||||||
125385881 | 12538588 | 3 | SS | PACLITAXEL. | PACLITAXEL | 1 | Intravenous (not otherwise specified) | 225 MG/M2 OVER 3 HOURS ON DAYS 1 AND 22 | U | U | 0 | 225 | MG/M**2 | ||||||
125385881 | 12538588 | 4 | SS | PACLITAXEL. | PACLITAXEL | 1 | Intravenous (not otherwise specified) | 45 MG/M2 ON DAY 43 | U | U | 0 | 45 | MG/M**2 | ||||||
125385881 | 12538588 | 5 | SS | Erlotinib | ERLOTINIB | 1 | Oral | 100 OR 150 MG, CONCURRENT CHEMOTHERAPY | U | U | 0 | ||||||||
125385881 | 12538588 | 6 | SS | Bevacizumab | BEVACIZUMAB | 1 | Intravenous (not otherwise specified) | 15 MG/KG ON DAYS 1 AND 22 | U | U | 0 | 15 | MG/KG | ||||||
125385881 | 12538588 | 7 | SS | Bevacizumab | BEVACIZUMAB | 1 | Intravenous (not otherwise specified) | 10 MG/KG, EVERY OTHER WEEK FOR FOUR DOSES, CONCURRENT CHEMOTHERAPY | U | U | 0 | 10 | MG/KG |
Indications of drugs used
Event ID | CASEID | INDI DRUG SEQ | INDI PT |
---|---|---|---|
125385881 | 12538588 | 1 | Non-small cell lung cancer stage III |
125385881 | 12538588 | 3 | Non-small cell lung cancer stage III |
125385881 | 12538588 | 5 | Non-small cell lung cancer stage III |
125385881 | 12538588 | 6 | Non-small cell lung cancer stage III |
Outcome of event
Event ID | CASEID | OUTC COD |
---|---|---|
125385881 | 12538588 | OT |
Reactions reported
Event ID | CASEID | DRUG REC ACT | PT |
---|---|---|---|
125385881 | 12538588 | Pneumonitis |
Reporting Sources (this data is often not reported and may therefore be missing here)
no results found |
Therapies reported
no results found |