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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126255261 | 12625526 | 1 | I | 20110318 | 20110405 | 20160805 | 20160805 | EXP | US-ROCHE-769605 | ROCHE | 54.42 | YR | M | Y | 112.60000 | KG | 20160805 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126255261 | 12625526 | 1 | PS | Vismodegib | VISMODEGIB | 1 | Oral | TOTAL DOSE ADMINISTERED 3000 MG.?ON 29/MAR/2011, 19/APR/2011, 10/MAY/2011, 21/JUN/2011, 02/AUG/2011, | 203388 | 3150 | MG | CAPSULE | QD | ||||||
| 126255261 | 12625526 | 2 | SS | Vismodegib | VISMODEGIB | 1 | Oral | 203388 | 3300 | MG | CAPSULE | QD | |||||||
| 126255261 | 12625526 | 3 | SS | Vismodegib | VISMODEGIB | 1 | Oral | 203388 | 3000 | MG | CAPSULE | QD | |||||||
| 126255261 | 12625526 | 4 | SS | Vismodegib | VISMODEGIB | 1 | Oral | 203388 | 2550 | MG | CAPSULE | QD | |||||||
| 126255261 | 12625526 | 5 | SS | Vismodegib | VISMODEGIB | 1 | Oral | 203388 | 3750 | MG | CAPSULE | QD | |||||||
| 126255261 | 12625526 | 6 | SS | ETOPOSIDE. | ETOPOSIDE | 1 | Intravenous (not otherwise specified) | DOSE FORM: 2 HOUR INFUSION ?DOSE FREQUENCY: DAYS 1-3 OF CYCLES 1-4?TOTAL DOSE RECEIVED 717 MG. | 0 | 100 | MG/M**2 | ||||||||
| 126255261 | 12625526 | 7 | SS | CISPLATIN. | CISPLATIN | 1 | Intravenous (not otherwise specified) | DOSE FORM: 2 HOUR INFUSION?DOSE FREQUENCY: DAY 1 OF CYCLE 1-4?TOTAL DOSE RECEIVED 179.25 MG | 0 | 75 | MG/M**2 | ||||||||
| 126255261 | 12625526 | 8 | C | ASA | ASPIRIN | 1 | 0 | ||||||||||||
| 126255261 | 12625526 | 9 | C | FEXOFENADINE | FEXOFENADINEFEXOFENADINE HYDROCHLORIDE | 1 | 0 | ||||||||||||
| 126255261 | 12625526 | 10 | C | JANUMET | METFORMIN HYDROCHLORIDESITAGLIPTIN PHOSPHATE | 1 | Unknown | DOSE REPORTED : 50/1000MG | 0 | BID | |||||||||
| 126255261 | 12625526 | 11 | C | LANTUS | INSULIN GLARGINE | 1 | Unknown | DOSE : 5 UNITS SQ EVERY NIGHT. | 0 | ||||||||||
| 126255261 | 12625526 | 12 | C | LOMOTIL (UNITED STATES) | 2 | Oral | DOSE FORM:TABLET? DOSE FREQUENCY: 1 TABLET TWICE A DAY AS REQUIRED | 0 | 1 | DF | TABLET | ||||||||
| 126255261 | 12625526 | 13 | C | NASONEX | MOMETASONE FUROATE | 1 | Unknown | DOSE FREQUECY: EVERY 12 HRS IF NEEDED | 0 | 50 | UG | ||||||||
| 126255261 | 12625526 | 14 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | Oral | 0 | 20 | MG | BID | ||||||||
| 126255261 | 12625526 | 15 | C | SINGULAIR | MONTELUKAST SODIUM | 1 | Unknown | DREPORTED AS: SINGULAR | 0 | ||||||||||
| 126255261 | 12625526 | 16 | C | VENTOLIN | ALBUTEROL SULFATE | 1 | Unknown | DOSE FORM: PUFF ?DOSE FREQUENCY ADDED: 1 PUFF EVERY 6 HOURS AS REQUIRED?REPORTED NAME: VENTOUN | 0 | 90 | UG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126255261 | 12625526 | 1 | Small cell lung cancer |
| 126255261 | 12625526 | 6 | Small cell lung cancer |
| 126255261 | 12625526 | 7 | Small cell lung cancer |
| 126255261 | 12625526 | 12 | Diarrhoea |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126255261 | 12625526 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126255261 | 12625526 | Leukocytosis | |
| 126255261 | 12625526 | Lung infection | |
| 126255261 | 12625526 | Neutrophil 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 |
|---|---|---|---|---|---|---|
| 126255261 | 12625526 | 1 | 20110301 | 20130402 | 0 | |
| 126255261 | 12625526 | 6 | 20110401 | 0 | ||
| 126255261 | 12625526 | 7 | 20110401 | 0 |