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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 98155733 | 9815573 | 3 | F | 20100317 | 20160706 | 20140114 | 20160811 | EXP | US-ROCHE-1038822 | ROCHE | 56.00 | YR | M | Y | 69.10000 | KG | 20160811 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 98155733 | 9815573 | 1 | PS | Vismodegib | VISMODEGIB | 1 | Oral | 203388 | 3150 | MG | CAPSULE | QD | |||||||
| 98155733 | 9815573 | 2 | SS | Vismodegib | VISMODEGIB | 1 | Oral | 203388 | 3300 | MG | CAPSULE | QD | |||||||
| 98155733 | 9815573 | 3 | SS | Vismodegib | VISMODEGIB | 1 | Oral | 203388 | 4200 | MG | CAPSULE | QD | |||||||
| 98155733 | 9815573 | 4 | SS | Vismodegib | VISMODEGIB | 1 | Oral | 203388 | 3450 | MG | CAPSULE | QD | |||||||
| 98155733 | 9815573 | 5 | SS | Vismodegib | VISMODEGIB | 1 | Oral | 203388 | 3450 | MG | CAPSULE | QD | |||||||
| 98155733 | 9815573 | 6 | SS | CISPLATIN. | CISPLATIN | 1 | Intravenous (not otherwise specified) | LAST DOSE PRIOR TO SAE: 09/MAR/2010. TOTAL DOSE ADMINISTERED IN THE COURSE PRIOR TO SAE: 135MG | 0 | 75 | MG/M**2 | ||||||||
| 98155733 | 9815573 | 7 | SS | ETOPOSIDE. | ETOPOSIDE | 1 | Intravenous (not otherwise specified) | LAST DOSE PRIOR TO SAE: 11/MAR/2010. TOTAL DOSE ADMINISTERED IN THE COURSE PRIOR TO SAE: 540MG | 0 | 100 | MG/M**2 | ||||||||
| 98155733 | 9815573 | 8 | SS | WARFARIN | WARFARIN | 1 | Unknown | U | 0 | ||||||||||
| 98155733 | 9815573 | 9 | SS | CIPROFLOXACIN. | CIPROFLOXACIN | 1 | Unknown | U | 0 | 500 | MG | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 98155733 | 9815573 | 1 | Small cell lung cancer |
| 98155733 | 9815573 | 6 | Small cell lung cancer |
| 98155733 | 9815573 | 7 | Small cell lung cancer |
| 98155733 | 9815573 | 8 | Product used for unknown indication |
| 98155733 | 9815573 | 9 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 98155733 | 9815573 | LT |
| 98155733 | 9815573 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 98155733 | 9815573 | Febrile neutropenia | |
| 98155733 | 9815573 | International normalised ratio increased | |
| 98155733 | 9815573 | Neutrophil count decreased | |
| 98155733 | 9815573 | 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 |
|---|---|---|---|---|---|---|
| 98155733 | 9815573 | 1 | 20100309 | 0 | ||
| 98155733 | 9815573 | 2 | 20100330 | 0 | ||
| 98155733 | 9815573 | 3 | 20100421 | 0 | ||
| 98155733 | 9815573 | 4 | 20100519 | 0 | ||
| 98155733 | 9815573 | 5 | 20100611 | 20100620 | 0 | |
| 98155733 | 9815573 | 6 | 20100309 | 0 | ||
| 98155733 | 9815573 | 7 | 20100309 | 0 |