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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126053981 | 12605398 | 1 | I | 20110415 | 20121109 | 20160729 | 20160729 | EXP | US-ROCHE-1154312 | ROCHE | 72.00 | YR | F | Y | 75.50000 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126053981 | 12605398 | 1 | PS | Vismodegib | VISMODEGIB | 1 | Oral | LAST DOSE RECEIVED ON 26/MAY/2011?COURSE 1 | 203388 | 4200 | MG | CAPSULE | QD | ||||||
| 126053981 | 12605398 | 2 | SS | Vismodegib | VISMODEGIB | 1 | Oral | LAST DOSE RECEIVED ON 26/MAY/2011?COURSE 2 | 203388 | 2550 | MG | CAPSULE | |||||||
| 126053981 | 12605398 | 3 | SS | CISPLATIN. | CISPLATIN | 1 | Intravenous (not otherwise specified) | 0 | 75 | MG/M**2 | |||||||||
| 126053981 | 12605398 | 4 | SS | ETOPOSIDE. | ETOPOSIDE | 1 | Intravenous (not otherwise specified) | LAST DOSE PRIOR TO SAE:07/APR/2011 | 0 | 100 | MG/M**2 | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126053981 | 12605398 | 1 | Small cell lung cancer |
| 126053981 | 12605398 | 3 | Small cell lung cancer |
| 126053981 | 12605398 | 4 | Small cell lung cancer |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126053981 | 12605398 | OT |
| 126053981 | 12605398 | LT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126053981 | 12605398 | Dyspnoea | |
| 126053981 | 12605398 | Hyperglycaemia | |
| 126053981 | 12605398 | Hyponatraemia | |
| 126053981 | 12605398 | Neutrophil count decreased | |
| 126053981 | 12605398 | 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 |
|---|---|---|---|---|---|---|
| 126053981 | 12605398 | 1 | 20110405 | 0 | ||
| 126053981 | 12605398 | 2 | 20110510 | 0 | ||
| 126053981 | 12605398 | 3 | 20110405 | 20110405 | 0 | |
| 126053981 | 12605398 | 4 | 20110405 | 20110407 | 0 |