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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126093081 | 12609308 | 1 | I | 20101214 | 20120418 | 20160801 | 20160801 | EXP | US-ROCHE-1060769 | ROCHE | 66.00 | YR | F | Y | 49.90000 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126093081 | 12609308 | 1 | PS | Vismodegib | VISMODEGIB | 1 | Oral | TREATMENT ASSIGNED CODE: ARM B, COURSE 1 (3150 MG) | 203388 | 150 | MG | QD | |||||||
| 126093081 | 12609308 | 2 | SS | Vismodegib | VISMODEGIB | 1 | Oral | TREATMENT ASSIGNED CODE: ARM B, COURSE 2 | 203388 | 3150 | MG | QD | |||||||
| 126093081 | 12609308 | 3 | SS | Vismodegib | VISMODEGIB | 1 | Oral | TREATMENT ASSIGNED CODE: ARM B, COURSE 3 | 203388 | 3150 | MG | QD | |||||||
| 126093081 | 12609308 | 4 | SS | Vismodegib | VISMODEGIB | 1 | Oral | TREATMENT ASSIGNED CODE: ARM B, COURSE 4 | 203388 | 3450 | MG | QD | |||||||
| 126093081 | 12609308 | 5 | SS | Vismodegib | VISMODEGIB | 1 | Oral | TREATMENT ASSIGNED CODE: ARM B, COURSE 5 | 203388 | 3150 | MG | QD | |||||||
| 126093081 | 12609308 | 6 | SS | Vismodegib | VISMODEGIB | 1 | Oral | TREATMENT ASSIGNED CODE: ARM B, COURSE 6 | 203388 | 3150 | MG | QD | |||||||
| 126093081 | 12609308 | 7 | SS | Vismodegib | VISMODEGIB | 1 | Oral | TREATMENT ASSIGNED CODE: ARM B, COURSE 7 | 203388 | 3150 | MG | QD | |||||||
| 126093081 | 12609308 | 8 | SS | Vismodegib | VISMODEGIB | 1 | Oral | TREATMENT ASSIGNED CODE: ARM B, COURSE 8 | 203388 | 3150 | MG | QD | |||||||
| 126093081 | 12609308 | 9 | SS | ETOPOSIDE. | ETOPOSIDE | 1 | Intravenous (not otherwise specified) | CYCLE =21DAYS, ON CYCLE 4 AT TIME OF EVENT, TOTAL DOSE ADMINISTERED THIS COURSE 152MG, LAST DOSE PRI | 0 | 100 | MG/M**2 | ||||||||
| 126093081 | 12609308 | 10 | SS | CISPLATIN. | CISPLATIN | 1 | Intravenous (not otherwise specified) | ON CYCLE 4 AT TIME OF EVENT, TOTAL DOSE ADMINISTERED THIS COURSE 113 MG, LAST DOSE PRIOR TO SAE 06/D | 0 | 75 | MG/M**2 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126093081 | 12609308 | 1 | Small cell lung cancer |
| 126093081 | 12609308 | 9 | Small cell lung cancer |
| 126093081 | 12609308 | 10 | Small cell lung cancer |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126093081 | 12609308 | OT |
| 126093081 | 12609308 | LT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126093081 | 12609308 | Arthralgia | |
| 126093081 | 12609308 | Back pain | |
| 126093081 | 12609308 | Pain | |
| 126093081 | 12609308 | Platelet count decreased | |
| 126093081 | 12609308 | 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 |
|---|---|---|---|---|---|---|
| 126093081 | 12609308 | 1 | 20100927 | 0 | ||
| 126093081 | 12609308 | 2 | 20101018 | 0 | ||
| 126093081 | 12609308 | 3 | 20101115 | 0 | ||
| 126093081 | 12609308 | 4 | 20101206 | 0 | ||
| 126093081 | 12609308 | 5 | 20101229 | 0 | ||
| 126093081 | 12609308 | 6 | 20110119 | 0 | ||
| 126093081 | 12609308 | 7 | 20110209 | 0 | ||
| 126093081 | 12609308 | 8 | 20110302 | 0 | ||
| 126093081 | 12609308 | 9 | 20100927 | 20101208 | 0 | |
| 126093081 | 12609308 | 10 | 20100927 | 20101206 | 0 |