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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126130941 | 12613094 | 1 | I | 20110520 | 20110818 | 20160802 | 20160802 | EXP | US-ROCHE-798295 | ROCHE | 70.63 | YR | F | Y | 55.40000 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126130941 | 12613094 | 1 | PS | Vismodegib | VISMODEGIB | 1 | Oral | TOTAL DOSE: 3150 MG, LAST DOSE: 12/AUG/2011 AND 22/MAY/2011 | 203388 | 3150 | MG | CAPSULE | QD | ||||||
| 126130941 | 12613094 | 2 | SS | Vismodegib | VISMODEGIB | 1 | Oral | 203388 | 3150 | MG | CAPSULE | QD | |||||||
| 126130941 | 12613094 | 3 | SS | Vismodegib | VISMODEGIB | 1 | Oral | 203388 | 2850 | MG | CAPSULE | QD | |||||||
| 126130941 | 12613094 | 4 | SS | Vismodegib | VISMODEGIB | 1 | Oral | 203388 | 2550 | MG | CAPSULE | QD | |||||||
| 126130941 | 12613094 | 5 | SS | Vismodegib | VISMODEGIB | 1 | Oral | 203388 | 1050 | MG | CAPSULE | QD | |||||||
| 126130941 | 12613094 | 6 | SS | CISPLATIN. | CISPLATIN | 1 | Intravenous (not otherwise specified) | IV OVER 2 HRS ON DAY 1, TOTAL DOSE:114 MG, LAST DOSE:12 JULY 2011 AND 02/MAY/2011. | 0 | 75 | MG/M**2 | ||||||||
| 126130941 | 12613094 | 7 | SS | ETOPOSIDE. | ETOPOSIDE | 1 | Intravenous (not otherwise specified) | IV OVER 2 HRS ON DAY 1-3, LAST DOSE PRIOR TO SAE 14 JULY 2011 AND 02/MAY/2011, TOTAL DOSE:456 MG | 0 | 100 | MG/M**2 | ||||||||
| 126130941 | 12613094 | 8 | SS | AUGMENTIN | AMOXICILLINCLAVULANATE POTASSIUM | 1 | Unknown | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126130941 | 12613094 | 1 | Small cell lung cancer |
| 126130941 | 12613094 | 6 | Small cell lung cancer |
| 126130941 | 12613094 | 7 | Small cell lung cancer |
| 126130941 | 12613094 | 8 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126130941 | 12613094 | HO |
| 126130941 | 12613094 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126130941 | 12613094 | Anaemia | |
| 126130941 | 12613094 | Diarrhoea | |
| 126130941 | 12613094 | Neutrophil count decreased | |
| 126130941 | 12613094 | 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 |
|---|---|---|---|---|---|---|
| 126130941 | 12613094 | 1 | 20110502 | 20110907 | 0 | |
| 126130941 | 12613094 | 6 | 20110502 | 0 | ||
| 126130941 | 12613094 | 7 | 20110502 | 0 |