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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 92179983 | 9217998 | 3 | F | 20110727 | 20160706 | 20130408 | 20160801 | EXP | US-ROCHE-796837 | ROCHE | 73.00 | YR | M | Y | 96.10000 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 92179983 | 9217998 | 1 | PS | Vismodegib | VISMODEGIB | 1 | Oral | TOTAL DOSE: 2400 MG, LAST DOSE: 27 JULY 2011 | 203388 | 150 | MG | QD | |||||||
| 92179983 | 9217998 | 2 | SS | Vismodegib | VISMODEGIB | 1 | Oral | TREATMENT ASSIGNED CODE: ARM B. COURSE 2 | 203388 | 3150 | MG | QD | |||||||
| 92179983 | 9217998 | 3 | SS | Vismodegib | VISMODEGIB | 1 | Oral | TREATMENT ASSIGNED CODE: ARM B. COURSE 3 | 203388 | 3150 | MG | QD | |||||||
| 92179983 | 9217998 | 4 | SS | Vismodegib | VISMODEGIB | 1 | Oral | TREATMENT ASSIGNED CODE: ARM B. COURSE 4 | 203388 | 4500 | MG | QD | |||||||
| 92179983 | 9217998 | 5 | SS | Vismodegib | VISMODEGIB | 1 | Oral | TREATMENT ASSIGNED CODE: ARM B. COURSE 5 | 203388 | 3150 | MG | QD | |||||||
| 92179983 | 9217998 | 6 | SS | Vismodegib | VISMODEGIB | 1 | Oral | TREATMENT ASSIGNED CODE: ARM B. COURSE 6 | 203388 | 2250 | MG | QD | |||||||
| 92179983 | 9217998 | 7 | SS | CISPLATIN. | CISPLATIN | 1 | Intravenous (not otherwise specified) | FREQUENCY: OVER 2 HOURS ON DAY 1?LAST DOSE PRIOR TO SAE: 12/JUL/2011 (TOTAL DOSE: 204 MG) | 0 | 75 | MG/M**2 | ||||||||
| 92179983 | 9217998 | 8 | SS | ETOPOSIDE. | ETOPOSIDE | 1 | Intravenous (not otherwise specified) | FREQUENCY: OVER 2 HOURS ON DAYS 1-3 (21 DAYS CYCLE)?LAST DOSE PRIOR TO SAE: 14/JUL/2011 (TOTAL DOSE: | 0 | 100 | MG/M**2 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 92179983 | 9217998 | 1 | Small cell lung cancer |
| 92179983 | 9217998 | 7 | Small cell lung cancer |
| 92179983 | 9217998 | 8 | Small cell lung cancer |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 92179983 | 9217998 | HO |
| 92179983 | 9217998 | LT |
| 92179983 | 9217998 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 92179983 | 9217998 | Anaemia | |
| 92179983 | 9217998 | Blood alkaline phosphatase increased | |
| 92179983 | 9217998 | Febrile neutropenia | |
| 92179983 | 9217998 | Hypercalcaemia | |
| 92179983 | 9217998 | Hypotension | |
| 92179983 | 9217998 | Musculoskeletal chest pain | |
| 92179983 | 9217998 | Weight decreased | |
| 92179983 | 9217998 | 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 |
|---|---|---|---|---|---|---|
| 92179983 | 9217998 | 6 | 20111103 | 20111117 | 0 | |
| 92179983 | 9217998 | 7 | 20110712 | 0 | ||
| 92179983 | 9217998 | 8 | 20110712 | 0 |