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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127340841 | 12734084 | 1 | I | 201409 | 20160622 | 20160912 | 20160912 | PER | US-JNJFOC-20160621110 | JANSSEN | 82.30 | YR | E | M | Y | 0.00000 | 20160912 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127340841 | 12734084 | 1 | SS | XARELTO | RIVAROXABAN | 1 | Oral | N | UNKNOWN | 0 | 20 | MG | TABLET | QD | |||||
| 127340841 | 12734084 | 2 | PS | XARELTO | RIVAROXABAN | 1 | Oral | N | UNKNOWN | 202439 | 20 | MG | TABLET | QD | |||||
| 127340841 | 12734084 | 3 | SS | AMIODARONE | AMIODARONE | 1 | Oral | 0 | TABLET | ||||||||||
| 127340841 | 12734084 | 4 | C | VITAMINS C | 2 | Oral | 0 | 2000 | MG | TABLET | QD | ||||||||
| 127340841 | 12734084 | 5 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | Oral | 0 | 20 | MG | TABLET | QD | |||||||
| 127340841 | 12734084 | 6 | C | LIPITOR | ATORVASTATIN CALCIUM | 1 | Oral | 0 | 20 | MG | TABLET | QD | |||||||
| 127340841 | 12734084 | 7 | C | LISINOPRIL. | LISINOPRIL | 1 | Oral | 0 | 20 | MG | TABLET | QD | |||||||
| 127340841 | 12734084 | 8 | C | LISINOPRIL. | LISINOPRIL | 1 | Oral | 0 | 40 | MG | TABLET | QD | |||||||
| 127340841 | 12734084 | 9 | C | METFORMIN | METFORMIN HYDROCHLORIDE | 1 | Oral | 0 | 1000 | MG | TABLET | QD | |||||||
| 127340841 | 12734084 | 10 | C | SYNTHROID | LEVOTHYROXINE SODIUM | 1 | Oral | 0 | .025 | MG | TABLET | QD | |||||||
| 127340841 | 12734084 | 11 | C | SYNTHROID | LEVOTHYROXINE SODIUM | 1 | Oral | 0 | .137 | MG | TABLET | QD | |||||||
| 127340841 | 12734084 | 12 | C | IRON | IRON | 1 | Oral | 0 | 65 | MG | TABLET | QOD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127340841 | 12734084 | 1 | Cerebrovascular accident prophylaxis |
| 127340841 | 12734084 | 2 | Atrial fibrillation |
| 127340841 | 12734084 | 3 | Atrial fibrillation |
| 127340841 | 12734084 | 4 | Supplementation therapy |
| 127340841 | 12734084 | 5 | Gastrooesophageal reflux disease |
| 127340841 | 12734084 | 6 | Blood cholesterol |
| 127340841 | 12734084 | 7 | Blood pressure measurement |
| 127340841 | 12734084 | 8 | Blood pressure measurement |
| 127340841 | 12734084 | 9 | Diabetes mellitus |
| 127340841 | 12734084 | 10 | Thyroid disorder |
| 127340841 | 12734084 | 11 | Thyroid disorder |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127340841 | 12734084 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127340841 | 12734084 | Abdominal distension | |
| 127340841 | 12734084 | Abdominal pain | |
| 127340841 | 12734084 | Agitation | |
| 127340841 | 12734084 | Arthralgia | |
| 127340841 | 12734084 | Asthenia | |
| 127340841 | 12734084 | Blood testosterone decreased | |
| 127340841 | 12734084 | Fatigue | |
| 127340841 | 12734084 | Gingival bleeding | |
| 127340841 | 12734084 | Internal haemorrhage | |
| 127340841 | 12734084 | Thyroid disorder |
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 |
|---|---|---|---|---|---|---|
| 127340841 | 12734084 | 1 | 201409 | 0 | ||
| 127340841 | 12734084 | 2 | 201409 | 0 | ||
| 127340841 | 12734084 | 3 | 201409 | 0 | ||
| 127340841 | 12734084 | 4 | 2011 | 0 | ||
| 127340841 | 12734084 | 5 | 2006 | 0 | ||
| 127340841 | 12734084 | 6 | 1996 | 0 | ||
| 127340841 | 12734084 | 7 | 20160621 | 0 | ||
| 127340841 | 12734084 | 12 | 201607 | 0 |