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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126056061 | 12605606 | 1 | I | 20100310 | 20110311 | 20160729 | 20160729 | EXP | US-ROCHE-772082 | ROCHE | 61.35 | YR | F | Y | 76.40000 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126056061 | 12605606 | 1 | PS | Vismodegib | VISMODEGIB | 1 | Oral | 150 MG, QD CYCLE 21 DAYS, COURSE 1 | 7200 | MG | U | NOT REPORTED | 203388 | CAPSULE | QD | ||||
| 126056061 | 12605606 | 2 | SS | Vismodegib | VISMODEGIB | 1 | Oral | COURSE 2 | 7200 | MG | U | NOT REPORTED | 203388 | CAPSULE | |||||
| 126056061 | 12605606 | 3 | SS | Vismodegib | VISMODEGIB | 1 | Oral | COURSE 3 | 7200 | MG | U | NOT REPORTED | 203388 | CAPSULE | |||||
| 126056061 | 12605606 | 4 | SS | Vismodegib | VISMODEGIB | 1 | Oral | COURSE 4 | 7200 | MG | U | NOT REPORTED | 203388 | CAPSULE | |||||
| 126056061 | 12605606 | 5 | SS | Vismodegib | VISMODEGIB | 1 | Oral | COURSE 5 | 7200 | MG | U | NOT REPORTED | 203388 | CAPSULE | |||||
| 126056061 | 12605606 | 6 | SS | CISPLATIN. | CISPLATIN | 1 | Intravenous (not otherwise specified) | 75 MG/M2, Q21D | U | 0 | 75 | MG/M**2 | |||||||
| 126056061 | 12605606 | 7 | SS | ETOPOSIDE. | ETOPOSIDE | 1 | Intravenous (not otherwise specified) | 100 MG/M2, QDX3D/21DC | U | 0 | 100 | MG/M**2 | |||||||
| 126056061 | 12605606 | 8 | C | EMEND | APREPITANT | 1 | 0 | ||||||||||||
| 126056061 | 12605606 | 9 | C | ALOXI | PALONOSETRON HYDROCHLORIDE | 1 | 0 | ||||||||||||
| 126056061 | 12605606 | 10 | C | DECADRON | DEXAMETHASONE | 1 | 0 | ||||||||||||
| 126056061 | 12605606 | 11 | C | ZOFRAN | ONDANSETRON HYDROCHLORIDE | 1 | Unknown | UNK | 0 | QD | |||||||||
| 126056061 | 12605606 | 12 | C | ZOFRAN | ONDANSETRON HYDROCHLORIDE | 1 | Unknown | 0 | |||||||||||
| 126056061 | 12605606 | 13 | C | ATIVAN | LORAZEPAM | 1 | Unknown | UNK | 0 | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126056061 | 12605606 | 1 | Small cell lung cancer |
| 126056061 | 12605606 | 6 | Small cell lung cancer |
| 126056061 | 12605606 | 7 | Small cell lung cancer |
| 126056061 | 12605606 | 8 | Premedication |
| 126056061 | 12605606 | 9 | Premedication |
| 126056061 | 12605606 | 10 | Premedication |
| 126056061 | 12605606 | 11 | Product used for unknown indication |
| 126056061 | 12605606 | 13 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126056061 | 12605606 | OT |
| 126056061 | 12605606 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126056061 | 12605606 | Abdominal infection | |
| 126056061 | 12605606 | Abdominal pain | |
| 126056061 | 12605606 | Colitis | |
| 126056061 | 12605606 | Decreased appetite | |
| 126056061 | 12605606 | Enterocolitis infectious | |
| 126056061 | 12605606 | Headache | |
| 126056061 | 12605606 | Hyponatraemia | |
| 126056061 | 12605606 | Hypophosphataemia | |
| 126056061 | 12605606 | Nausea | |
| 126056061 | 12605606 | Neutrophil count decreased | |
| 126056061 | 12605606 | Oesophageal spasm | |
| 126056061 | 12605606 | Vomiting | |
| 126056061 | 12605606 | Weight decreased | |
| 126056061 | 12605606 | 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 |
|---|---|---|---|---|---|---|
| 126056061 | 12605606 | 1 | 20100310 | 20100511 | 0 | |
| 126056061 | 12605606 | 5 | 20100623 | 20100708 | 0 | |
| 126056061 | 12605606 | 12 | 20100317 | 20100319 | 0 |