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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126052001 | 12605200 | 1 | I | 20160505 | 20160727 | 20160729 | 20160729 | EXP | US-ROCHE-1803499 | ROCHE | 50.59 | YR | F | Y | 54.93000 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126052001 | 12605200 | 1 | PS | CAPECITABINE. | CAPECITABINE | 1 | Oral | LAST DOSE PRIOR TO SAE: 07/MAY/2016 | 20896 | 2500 | MG | TABLET | |||||||
| 126052001 | 12605200 | 2 | C | MORPHINE | MORPHINE | 1 | Oral | 0 | 15 | MG | BID | ||||||||
| 126052001 | 12605200 | 3 | C | MAGIC MOUTH RINSE (KAOPECTATE, VISCOUS LIDOCAINE, BENADRYL) | 2 | Oral | 0 | 5 | ML | ||||||||||
| 126052001 | 12605200 | 4 | C | ATROPINE SULFATE/DIPHENOXYLATE HYDROCHLORIDE | ATROPINE SULFATEDIPHENOXYLATE HYDROCHLORIDE | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126052001 | 12605200 | 1 | Breast cancer |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126052001 | 12605200 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126052001 | 12605200 | Abdominal pain | |
| 126052001 | 12605200 | Dehydration | |
| 126052001 | 12605200 | Diarrhoea | |
| 126052001 | 12605200 | Enterocolitis | |
| 126052001 | 12605200 | Pleural effusion | |
| 126052001 | 12605200 | Vomiting |
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 |
|---|---|---|---|---|---|---|
| 126052001 | 12605200 | 1 | 20160406 | 20160507 | 0 | |
| 126052001 | 12605200 | 2 | 20160426 | 0 | ||
| 126052001 | 12605200 | 3 | 20160405 | 0 |