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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127804941 | 12780494 | 1 | I | 20100531 | 20100601 | 20160926 | 20160926 | EXP | PHHO2010IN022013 | NOVARTIS | 64.66 | YR | M | Y | 39.00000 | KG | 20160926 | MD | IN | IN |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127804941 | 12780494 | 1 | PS | PLACEBO | UNSPECIFIED INGREDIENT | 1 | Oral | UNK | D | 0 | |||||||||
| 127804941 | 12780494 | 2 | SS | COMPARATOR CAPECITABINE | CAPECITABINE | 1 | Oral | 1700 MG/M2, BID | D | 0 | 1700 | MG/M**2 | BID | ||||||
| 127804941 | 12780494 | 3 | SS | COMPARATOR OXALIPLATIN | OXALIPLATIN | 1 | Intravenous (not otherwise specified) | 130 MG/M2, CYCLIC | D | 0 | 130 | MG/M**2 | |||||||
| 127804941 | 12780494 | 4 | C | MULTIVIT /07591901/ | 2 | Oral | UNK | D | 0 | ||||||||||
| 127804941 | 12780494 | 5 | C | OROFER /01249901/ | 2 | Oral | UNK | D | 0 | ||||||||||
| 127804941 | 12780494 | 6 | C | ONDANSETRON | ONDANSETRON | 1 | Oral | 8 MG, TID | D | 0 | 8 | MG | TID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127804941 | 12780494 | 1 | Gastric cancer |
| 127804941 | 12780494 | 2 | Gastric cancer |
| 127804941 | 12780494 | 3 | Gastric cancer |
| 127804941 | 12780494 | 4 | Product used for unknown indication |
| 127804941 | 12780494 | 5 | Product used for unknown indication |
| 127804941 | 12780494 | 6 | Vomiting |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127804941 | 12780494 | OT |
| 127804941 | 12780494 | LT |
| 127804941 | 12780494 | HO |
| 127804941 | 12780494 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127804941 | 12780494 | Dehydration | |
| 127804941 | 12780494 | Hyponatraemia | |
| 127804941 | 12780494 | Hypotension | |
| 127804941 | 12780494 | Multiple organ dysfunction syndrome | |
| 127804941 | 12780494 | Neutropenia | |
| 127804941 | 12780494 | Sepsis |
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 |
|---|---|---|---|---|---|---|
| 127804941 | 12780494 | 1 | 20100514 | 0 | ||
| 127804941 | 12780494 | 2 | 20100514 | 0 | ||
| 127804941 | 12780494 | 3 | 20100514 | 0 | ||
| 127804941 | 12780494 | 4 | 20100514 | 0 |