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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 119193894 | 11919389 | 4 | F | 201205 | 20160708 | 20160115 | 20160912 | PER | US-JNJFOC-20151225703 | JANSSEN | 64.48 | YR | A | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 119193894 | 11919389 | 1 | SS | XARELTO | RIVAROXABAN | 1 | Oral | N | UNKNOWN | 0 | 20 | MG | TABLET | QD | |||||
| 119193894 | 11919389 | 2 | SS | XARELTO | RIVAROXABAN | 1 | Oral | N | UNKNOWN | 0 | 20 | MG | TABLET | QD | |||||
| 119193894 | 11919389 | 3 | PS | XARELTO | RIVAROXABAN | 1 | Oral | N | UNKNOWN | 202439 | 20 | MG | TABLET | QD | |||||
| 119193894 | 11919389 | 4 | SS | PRADAXA | DABIGATRAN ETEXILATE MESYLATE | 1 | 0 | UNSPECIFIED | |||||||||||
| 119193894 | 11919389 | 5 | SS | PRADAXA | DABIGATRAN ETEXILATE MESYLATE | 1 | 0 | UNSPECIFIED | |||||||||||
| 119193894 | 11919389 | 6 | C | PREDNISONE. | PREDNISONE | 1 | Respiratory (inhalation) | 0 | INHALATION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 119193894 | 11919389 | 1 | Anticoagulant therapy |
| 119193894 | 11919389 | 2 | Cerebrovascular accident prophylaxis |
| 119193894 | 11919389 | 3 | Atrial fibrillation |
| 119193894 | 11919389 | 4 | Cerebrovascular accident prophylaxis |
| 119193894 | 11919389 | 5 | Atrial fibrillation |
| 119193894 | 11919389 | 6 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 119193894 | 11919389 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 119193894 | 11919389 | Gastrointestinal haemorrhage |
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 |
|---|---|---|---|---|---|---|
| 119193894 | 11919389 | 1 | 201203 | 201206 | 0 | |
| 119193894 | 11919389 | 2 | 201203 | 201206 | 0 | |
| 119193894 | 11919389 | 3 | 201203 | 201206 | 0 | |
| 119193894 | 11919389 | 4 | 201205 | 0 | ||
| 119193894 | 11919389 | 5 | 201205 | 0 |