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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 92584423 | 9258442 | 3 | F | 20100831 | 20160706 | 20130426 | 20160802 | EXP | US-ROCHE-772031 | ROCHE | 62.00 | YR | M | Y | 98.20000 | KG | 20160802 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 92584423 | 9258442 | 1 | PS | Vismodegib | VISMODEGIB | 1 | Oral | 150 MG, QD, LAST DOSE ADMINISTERED ON 12/NOV/2010 | 4650 | MG | NOT REPORTED | 203388 | |||||||
| 92584423 | 9258442 | 2 | SS | Vismodegib | VISMODEGIB | 1 | Oral | 150 MG, QD | 4650 | MG | NOT REPORTED | 203388 | 150 | MG | CAPSULE | QD | |||
| 92584423 | 9258442 | 3 | SS | Vismodegib | VISMODEGIB | 1 | Oral | COURSE 5 | 4650 | MG | NOT REPORTED | 203388 | 3000 | MG | |||||
| 92584423 | 9258442 | 4 | SS | Vismodegib | VISMODEGIB | 1 | Oral | COURSE 6 | 4650 | MG | NOT REPORTED | 203388 | 1500 | MG | |||||
| 92584423 | 9258442 | 5 | SS | Vismodegib | VISMODEGIB | 1 | Oral | COURSE 7 | 4650 | MG | NOT REPORTED | 203388 | 3150 | MG | |||||
| 92584423 | 9258442 | 6 | SS | Vismodegib | VISMODEGIB | 1 | Oral | COURSE 8 | 4650 | MG | NOT REPORTED | 203388 | 3300 | MG | |||||
| 92584423 | 9258442 | 7 | SS | ETOPOSIDE. | ETOPOSIDE | 1 | Intravenous (not otherwise specified) | 100 MG/M2, QDX3D/21DC, LAST DOSE ADMINISTERED ON 06/NOV/2010 | U | 0 | 100 | MG/M**2 | |||||||
| 92584423 | 9258442 | 8 | SS | CISPLATIN. | CISPLATIN | 1 | Intravenous (not otherwise specified) | 75 MG/M2, Q21D, LAST DSOE ON 11/APR/2010 | Y | 0 | 75 | MG/M**2 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 92584423 | 9258442 | 1 | Small cell lung cancer extensive stage |
| 92584423 | 9258442 | 7 | Small cell lung cancer extensive stage |
| 92584423 | 9258442 | 8 | Small cell lung cancer extensive stage |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 92584423 | 9258442 | HO |
| 92584423 | 9258442 | LT |
| 92584423 | 9258442 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 92584423 | 9258442 | Abdominal pain | |
| 92584423 | 9258442 | Back pain | |
| 92584423 | 9258442 | Constipation | |
| 92584423 | 9258442 | Dyspepsia | |
| 92584423 | 9258442 | Embolism | |
| 92584423 | 9258442 | Headache | |
| 92584423 | 9258442 | Hyponatraemia | |
| 92584423 | 9258442 | Inappropriate antidiuretic hormone secretion | |
| 92584423 | 9258442 | Memory impairment | |
| 92584423 | 9258442 | Mood swings | |
| 92584423 | 9258442 | Nausea | |
| 92584423 | 9258442 | Neutrophil count decreased | |
| 92584423 | 9258442 | Vomiting | |
| 92584423 | 9258442 | 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 |
|---|---|---|---|---|---|---|
| 92584423 | 9258442 | 1 | 20100824 | 20101112 | 0 | |
| 92584423 | 9258442 | 2 | 20101012 | 20101112 | 0 | |
| 92584423 | 9258442 | 6 | 20110118 | 20110208 | 0 | |
| 92584423 | 9258442 | 7 | 20101012 | 20110208 | 0 | |
| 92584423 | 9258442 | 8 | 20101012 | 20110208 | 0 |