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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126094871 | 12609487 | 1 | I | 20100426 | 20110311 | 20160801 | 20160801 | EXP | US-ROCHE-772128 | ROCHE | 53.15 | YR | M | Y | 62.10000 | KG | 20160801 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126094871 | 12609487 | 1 | PS | Vismodegib | VISMODEGIB | 1 | Oral | Y | NOT REPORTED | 203388 | 3150 | MG | CAPSULE | ||||||
| 126094871 | 12609487 | 2 | SS | Vismodegib | VISMODEGIB | 1 | Oral | Y | NOT REPORTED | 203388 | 4050 | MG | |||||||
| 126094871 | 12609487 | 3 | SS | Vismodegib | VISMODEGIB | 1 | Oral | Y | NOT REPORTED | 203388 | 3600 | MG | |||||||
| 126094871 | 12609487 | 4 | SS | CISPLATIN. | CISPLATIN | 1 | Intravenous (not otherwise specified) | 75 MG/M2 Q21D OVER 2 HRS ON DAY 1 | U | 0 | 75 | MG/M**2 | |||||||
| 126094871 | 12609487 | 5 | SS | ETOPOSIDE. | ETOPOSIDE | 1 | Intravenous (not otherwise specified) | 100 MG/M2 QD*3D/21DC, OVER 2 HOURS ON DAY 1-3 | U | 0 | 100 | MG/M**2 | /cycle |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126094871 | 12609487 | 1 | Small cell lung cancer extensive stage |
| 126094871 | 12609487 | 4 | Small cell lung cancer extensive stage |
| 126094871 | 12609487 | 5 | Small cell lung cancer extensive stage |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126094871 | 12609487 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126094871 | 12609487 | Headache | |
| 126094871 | 12609487 | Hyponatraemia | |
| 126094871 | 12609487 | Neutrophil 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 |
|---|---|---|---|---|---|---|
| 126094871 | 12609487 | 4 | 20100224 | 0 | ||
| 126094871 | 12609487 | 5 | 20100224 | 0 |