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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126051831 | 12605183 | 1 | I | 20110810 | 20111012 | 20160729 | 20160729 | EXP | US-ROCHE-1004074 | ROCHE | 69.00 | YR | M | Y | 76.70000 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126051831 | 12605183 | 1 | PS | Vismodegib | VISMODEGIB | 1 | Oral | 21 DAYS CYCLE?LAST DOSE ADMINISTERED: 14/SEP/2011 AND 15-NOV-2011 | 203388 | 2850 | MG | CAPSULE | QD | ||||||
| 126051831 | 12605183 | 2 | SS | Vismodegib | VISMODEGIB | 1 | Oral | 203388 | 4050 | MG | CAPSULE | ||||||||
| 126051831 | 12605183 | 3 | SS | Vismodegib | VISMODEGIB | 1 | Oral | 203388 | 4050 | MG | CAPSULE | ||||||||
| 126051831 | 12605183 | 4 | SS | Vismodegib | VISMODEGIB | 1 | Oral | 203388 | 4200 | MG | CAPSULE | ||||||||
| 126051831 | 12605183 | 5 | SS | Vismodegib | VISMODEGIB | 1 | Oral | 15/NOV/2011 | 203388 | 3150 | MG | CAPSULE | |||||||
| 126051831 | 12605183 | 6 | SS | Vismodegib | VISMODEGIB | 1 | Oral | 203388 | 3000 | MG | CAPSULE | ||||||||
| 126051831 | 12605183 | 7 | SS | ETOPOSIDE. | ETOPOSIDE | 1 | Intravenous (not otherwise specified) | OVER 2 HRS ON DAY 1-3?LAST DATE ADMINISTERED: 02/SEP/2011 AND 28-OCT-2011, DOSE DELAYED BY 7 DAYS | 0 | ||||||||||
| 126051831 | 12605183 | 8 | SS | CISPLATIN. | CISPLATIN | 1 | Intravenous (not otherwise specified) | OVER 2 HRS ON DAY 1?LAST DATE ADMINISTERED: 31/AUG/2011 AND 26-OCT-2011, DOSE DELAYED BY 7 DAYS. | 0 | 75 | MG/M**2 | ||||||||
| 126051831 | 12605183 | 9 | C | ATENOLOL. | ATENOLOL | 1 | Oral | QD | 0 | 100 | MG | ||||||||
| 126051831 | 12605183 | 10 | C | LISINOPRIL. | LISINOPRIL | 1 | Oral | QD | 0 | 40 | MG | ||||||||
| 126051831 | 12605183 | 11 | C | RISPERIDONE. | RISPERIDONE | 1 | Oral | QD | 0 | 4 | MG | ||||||||
| 126051831 | 12605183 | 12 | C | VENLAFAXINE | VENLAFAXINE HYDROCHLORIDE | 1 | Oral | QD | 0 | 150 | MG | ||||||||
| 126051831 | 12605183 | 13 | C | OMEPRAZON | OMEPRAZOLE | 1 | Oral | 0 | 20 | MG | QID | ||||||||
| 126051831 | 12605183 | 14 | C | OXYBUTYNIN | OXYBUTYNIN | 1 | Oral | 0 | 5 | MG | BID | ||||||||
| 126051831 | 12605183 | 15 | C | PRAZOSIN | PRAZOSIN | 1 | Oral | 0 | 5 | MG | BID | ||||||||
| 126051831 | 12605183 | 16 | C | AMLODIPINE | AMLODIPINE BESYLATE | 1 | Oral | QD | 0 | 5 | MG | ||||||||
| 126051831 | 12605183 | 17 | C | APREPITANT. | APREPITANT | 1 | Oral | 125MG DAY 1, AND 80MG DAY 2 AND 3 | 0 | ||||||||||
| 126051831 | 12605183 | 18 | C | OXYCODONE | OXYCODONE | 1 | Oral | 0 | 5 | MG | Q4H |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126051831 | 12605183 | 1 | Small cell lung cancer |
| 126051831 | 12605183 | 7 | Small cell lung cancer |
| 126051831 | 12605183 | 8 | Small cell lung cancer |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126051831 | 12605183 | HO |
| 126051831 | 12605183 | OT |
| 126051831 | 12605183 | LT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126051831 | 12605183 | Acidosis | |
| 126051831 | 12605183 | Delirium | |
| 126051831 | 12605183 | Dyspnoea | |
| 126051831 | 12605183 | Hypertension | |
| 126051831 | 12605183 | Neutrophil count decreased | |
| 126051831 | 12605183 | 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 |
|---|---|---|---|---|---|---|
| 126051831 | 12605183 | 1 | 20110810 | 0 | ||
| 126051831 | 12605183 | 2 | 20110831 | 0 | ||
| 126051831 | 12605183 | 3 | 20110831 | 0 | ||
| 126051831 | 12605183 | 4 | 20110928 | 0 | ||
| 126051831 | 12605183 | 5 | 20111026 | 0 | ||
| 126051831 | 12605183 | 6 | 20111207 | 0 | ||
| 126051831 | 12605183 | 7 | 20110810 | 0 | ||
| 126051831 | 12605183 | 8 | 20110810 | 0 |