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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126417813 | 12641781 | 3 | F | 20160401 | 20160819 | 20160810 | 20160906 | EXP | JP-JNJFOC-20160707571 | JANSSEN | 54.50 | YR | A | F | Y | 0.00000 | 20160906 | MD | JP | JP |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126417813 | 12641781 | 1 | PS | TRAMAL OD | TRAMADOL | 1 | Oral | Y | N | 20281 | 100 | MG | TABLETS | QD | |||||
| 126417813 | 12641781 | 2 | SS | DICLOFENAC SODIUM. | DICLOFENAC SODIUM | 1 | Oral | 0 | 75 | MG | UNSPECIFIED | ||||||||
| 126417813 | 12641781 | 3 | SS | SELBEX | TEPRENONE | 1 | Oral | 0 | 50 | MG | UNSPECIFIED | ||||||||
| 126417813 | 12641781 | 4 | SS | SELBEX | TEPRENONE | 1 | Oral | 0 | 100 | MG | UNSPECIFIED | ||||||||
| 126417813 | 12641781 | 5 | SS | GASTER | FAMOTIDINE | 1 | Oral | 0 | 20 | MG | UNSPECIFIED | ||||||||
| 126417813 | 12641781 | 6 | SS | CYTOTEC | MISOPROSTOL | 1 | Oral | Y | 0 | 100 | MG | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126417813 | 12641781 | 1 | Cancer pain |
| 126417813 | 12641781 | 2 | Cancer pain |
| 126417813 | 12641781 | 3 | Abdominal discomfort |
| 126417813 | 12641781 | 4 | Abdominal discomfort |
| 126417813 | 12641781 | 5 | Abdominal discomfort |
| 126417813 | 12641781 | 6 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126417813 | 12641781 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126417813 | 12641781 | Abdominal discomfort | |
| 126417813 | 12641781 | Constipation | |
| 126417813 | 12641781 | Decreased appetite | |
| 126417813 | 12641781 | Dysgeusia | |
| 126417813 | 12641781 | Gastrooesophageal reflux disease | |
| 126417813 | 12641781 | Somnolence |
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 |
|---|---|---|---|---|---|---|
| 126417813 | 12641781 | 1 | 20160302 | 20160709 | 0 | |
| 126417813 | 12641781 | 2 | 20160219 | 0 | ||
| 126417813 | 12641781 | 3 | 20160405 | 0 | ||
| 126417813 | 12641781 | 4 | 20160219 | 20160404 | 0 | |
| 126417813 | 12641781 | 5 | 20160507 | 0 | ||
| 126417813 | 12641781 | 6 | 20160606 | 20160606 | 0 |