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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126056421 | 12605642 | 1 | I | 20110615 | 20110914 | 20160729 | 20160729 | EXP | US-ROCHE-1008709 | ROCHE | 52.29 | YR | F | Y | 99.20000 | KG | 20160729 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126056421 | 12605642 | 1 | PS | Vismodegib | VISMODEGIB | 1 | Oral | U | 203388 | 3150 | MG | CAPSULE | QD | ||||||
| 126056421 | 12605642 | 2 | SS | Vismodegib | VISMODEGIB | 1 | Oral | U | 203388 | 2550 | MG | CAPSULE | QD | ||||||
| 126056421 | 12605642 | 3 | SS | Vismodegib | VISMODEGIB | 1 | Oral | U | 203388 | 4550 | MG | CAPSULE | QD | ||||||
| 126056421 | 12605642 | 4 | SS | CISPLATIN. | CISPLATIN | 1 | Intravenous (not otherwise specified) | IV OVER 2 HOURS ON DAY 1 | U | 0 | 75 | MG/M**2 | |||||||
| 126056421 | 12605642 | 5 | SS | ETOPOSIDE. | ETOPOSIDE | 1 | Intravenous (not otherwise specified) | DOSE: 100 MG/M2/DAY,IV OVER 2 HOURS ON DAYS 1-3 | U | 0 | |||||||||
| 126056421 | 12605642 | 6 | C | LISINOPRIL. | LISINOPRIL | 1 | 0 | ||||||||||||
| 126056421 | 12605642 | 7 | C | LORAZEPAM. | LORAZEPAM | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126056421 | 12605642 | 1 | Small cell lung cancer |
| 126056421 | 12605642 | 4 | Small cell lung cancer |
| 126056421 | 12605642 | 5 | Small cell lung cancer |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126056421 | 12605642 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126056421 | 12605642 | Hypertension | |
| 126056421 | 12605642 | Hypokalaemia | |
| 126056421 | 12605642 | Neutrophil count decreased | |
| 126056421 | 12605642 | Syncope | |
| 126056421 | 12605642 | White blood cell count decreased |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| Event ID | CASEID | DSG DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|---|
| 126056421 | 12605642 | 1 | 20110615 | 0 | ||
| 126056421 | 12605642 | 2 | 20110727 | 0 | ||
| 126056421 | 12605642 | 3 | 20110817 | 20111006 | 0 | |
| 126056421 | 12605642 | 4 | 20110615 | 0 | ||
| 126056421 | 12605642 | 5 | 20110615 | 0 |