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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 92938613 | 9293861 | 3 | F | 20110328 | 20160706 | 20130516 | 20160803 | EXP | US-ROCHE-778162 | ROCHE | 61.23 | YR | M | Y | 58.70000 | KG | 20160803 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 92938613 | 9293861 | 1 | PS | Vismodegib | VISMODEGIB | 1 | Oral | ON DAYS 1-21 | 203388 | 1650 | MG | CAPSULE | QD | ||||||
| 92938613 | 9293861 | 2 | SS | CISPLATIN. | CISPLATIN | 1 | Intravenous (not otherwise specified) | 0 | 75 | MG/M**2 | |||||||||
| 92938613 | 9293861 | 3 | SS | ETOPOSIDE. | ETOPOSIDE | 1 | Intravenous (not otherwise specified) | 0 | 100 | MG/M**2 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 92938613 | 9293861 | 1 | Small cell lung cancer |
| 92938613 | 9293861 | 2 | Small cell lung cancer |
| 92938613 | 9293861 | 3 | Small cell lung cancer |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 92938613 | 9293861 | DE |
| 92938613 | 9293861 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 92938613 | 9293861 | Acute respiratory distress syndrome | |
| 92938613 | 9293861 | Anaemia | |
| 92938613 | 9293861 | Hypermagnesaemia | |
| 92938613 | 9293861 | Hypoalbuminaemia | |
| 92938613 | 9293861 | Hypocalcaemia | |
| 92938613 | 9293861 | Hyponatraemia | |
| 92938613 | 9293861 | Hypotension | |
| 92938613 | 9293861 | Neutrophil count decreased | |
| 92938613 | 9293861 | 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 |
|---|---|---|---|---|---|---|
| 92938613 | 9293861 | 1 | 20110315 | 20110328 | 0 | |
| 92938613 | 9293861 | 2 | 20110315 | 20110328 | 0 | |
| 92938613 | 9293861 | 3 | 20110315 | 0 |