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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 98154343 | 9815434 | 3 | F | 20110830 | 20160706 | 20140114 | 20160810 | EXP | US-ROCHE-1004483 | ROCHE | 63.00 | YR | M | Y | 78.90000 | KG | 20160810 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 98154343 | 9815434 | 1 | PS | Vismodegib | VISMODEGIB | 1 | Oral | U | 203388 | 1950 | MG | CAPSULE | QD | ||||||
| 98154343 | 9815434 | 2 | SS | Vismodegib | VISMODEGIB | 1 | Oral | U | 203388 | 2550 | MG | CAPSULE | QD | ||||||
| 98154343 | 9815434 | 3 | SS | CISPLATIN. | CISPLATIN | 1 | Intravenous (not otherwise specified) | U | 0 | 75 | MG/M**2 | ||||||||
| 98154343 | 9815434 | 4 | SS | CISPLATIN. | CISPLATIN | 1 | Intravenous (not otherwise specified) | DOSE REDUCTION OF 25% | U | 0 | |||||||||
| 98154343 | 9815434 | 5 | SS | ETOPOSIDE. | ETOPOSIDE | 1 | Intravenous (not otherwise specified) | U | 0 | 100 | MG/M**2 | ||||||||
| 98154343 | 9815434 | 6 | SS | ETOPOSIDE. | ETOPOSIDE | 1 | Intravenous (not otherwise specified) | DOSE REDUCTION OF 25% | U | 0 | 75 | MG/M**2 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 98154343 | 9815434 | 1 | Small cell lung cancer |
| 98154343 | 9815434 | 3 | Small cell lung cancer |
| 98154343 | 9815434 | 5 | Small cell lung cancer |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 98154343 | 9815434 | OT |
| 98154343 | 9815434 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 98154343 | 9815434 | Diarrhoea | |
| 98154343 | 9815434 | Febrile neutropenia | |
| 98154343 | 9815434 | Lung infection | |
| 98154343 | 9815434 | Muscular weakness | |
| 98154343 | 9815434 | Nausea | |
| 98154343 | 9815434 | Neutrophil count decreased | |
| 98154343 | 9815434 | Oesophagitis | |
| 98154343 | 9815434 | Upper gastrointestinal haemorrhage | |
| 98154343 | 9815434 | Vomiting | |
| 98154343 | 9815434 | 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 |
|---|---|---|---|---|---|---|
| 98154343 | 9815434 | 1 | 20110816 | 0 | ||
| 98154343 | 9815434 | 2 | 20110913 | 0 | ||
| 98154343 | 9815434 | 3 | 20110816 | 0 | ||
| 98154343 | 9815434 | 5 | 20110816 | 0 |