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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126354621 | 12635462 | 1 | I | 2013 | 20160802 | 20160809 | 20160809 | EXP | US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2016-BI-50672BP | BOEHRINGER INGELHEIM | 76.68 | YR | F | Y | 0.00000 | 20160809 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126354621 | 12635462 | 1 | PS | DULCOLAX STOOL SOFTENER | DOCUSATE SODIUM | 1 | Oral | U | 4HE1413A | 0 | 100 | MG | CAPSULE | ||||||
| 126354621 | 12635462 | 2 | C | Calcium | CALCIUM | 1 | Oral | 0 | |||||||||||
| 126354621 | 12635462 | 3 | C | COUMADIN | WARFARIN SODIUM | 1 | Oral | 4 MG | 0 | 4 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126354621 | 12635462 | 1 | Constipation |
| 126354621 | 12635462 | 2 | Product used for unknown indication |
| 126354621 | 12635462 | 3 | Thrombosis prophylaxis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126354621 | 12635462 | HO |
| 126354621 | 12635462 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126354621 | 12635462 | Abnormal loss of weight | |
| 126354621 | 12635462 | Asthenia | |
| 126354621 | 12635462 | Breast cancer | |
| 126354621 | 12635462 | Cervix carcinoma | |
| 126354621 | 12635462 | Constipation | |
| 126354621 | 12635462 | Gait disturbance | |
| 126354621 | 12635462 | Inguinal hernia | |
| 126354621 | 12635462 | Pain in extremity | |
| 126354621 | 12635462 | Precancerous skin lesion | |
| 126354621 | 12635462 | Radiation skin injury | |
| 126354621 | 12635462 | Sinusitis | |
| 126354621 | 12635462 | Squamous cell carcinoma of skin | |
| 126354621 | 12635462 | Thrombosis | |
| 126354621 | 12635462 | Thrombosis in device | |
| 126354621 | 12635462 | Transient ischaemic attack |
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 |
|---|---|---|---|---|---|---|
| 126354621 | 12635462 | 3 | 2015 | 0 |