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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123134652 | 12313465 | 2 | F | 20160728 | 20160428 | 20160805 | EXP | DE-DRREDDYS-USA/GER/16/0079142 | DR REDDYS | HOELTZENBEIN M, BECK E, MEIXNER K, SCHAEFER C, KREUTZ R. PREGNANCY OUTCOME AFTER EXPOSURE TO THE NOVEL ORAL ANTICOAGULANT RIVAROXABAN IN WOMEN AT SUSPECTED RISK FOR THROMBOEMBOLIC EVENTS: A CASE SERIES FROM THE GERMAN EMBRYOTOX PHARMACOVIGILANCE CENTRE. CLIN RES CARDIOL. 2016;105(2):117-26. | 0.00 | F | Y | 0.00000 | 20160805 | OT | COUNTRY NOT SPECIFIED | DE |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123134652 | 12313465 | 1 | PS | RAMIPRIL. | RAMIPRIL | 1 | Unknown | U | U | UNKNOWN | 78191 | ||||||||
| 123134652 | 12313465 | 2 | SS | pantoprazole | PANTOPRAZOLE SODIUM | 1 | Unknown | U | U | UNKNOWN | 77619 | ||||||||
| 123134652 | 12313465 | 3 | SS | SIMVASTATIN. | SIMVASTATIN | 1 | Unknown | U | U | UNKNOWN | 77752 | ||||||||
| 123134652 | 12313465 | 4 | SS | hydroxychloroquine | HYDROXYCHLOROQUINE | 1 | Unknown | 0 | |||||||||||
| 123134652 | 12313465 | 5 | SS | PREDNISOLONE. | PREDNISOLONE | 1 | Unknown | 0 | |||||||||||
| 123134652 | 12313465 | 6 | SS | torasemide | TORSEMIDE | 1 | Unknown | 0 | |||||||||||
| 123134652 | 12313465 | 7 | SS | TACROLIMUS. | TACROLIMUS | 1 | Unknown | 0 | |||||||||||
| 123134652 | 12313465 | 8 | SS | EZETIMIBE. | EZETIMIBE | 1 | Unknown | 0 | |||||||||||
| 123134652 | 12313465 | 9 | SS | acetylsalicylic acid | ASPIRIN | 1 | Unknown | 0 | |||||||||||
| 123134652 | 12313465 | 10 | SS | salbutamol | ALBUTEROL | 1 | Unknown | 0 | |||||||||||
| 123134652 | 12313465 | 11 | SS | metamizole | METAMIZOLE | 1 | Unknown | 0 | |||||||||||
| 123134652 | 12313465 | 12 | SS | aliskiren | ALISKIREN | 1 | Unknown | 0 | |||||||||||
| 123134652 | 12313465 | 13 | SS | rivaroxaban | RIVAROXABAN | 1 | Unknown | 0 | 10 | MG | QD | ||||||||
| 123134652 | 12313465 | 14 | SS | HEPARIN | HEPARIN SODIUM | 1 | 0 | ||||||||||||
| 123134652 | 12313465 | 15 | SS | rituximab | RITUXIMAB | 1 | 0 | ||||||||||||
| 123134652 | 12313465 | 16 | SS | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123134652 | 12313465 | 1 | Product used for unknown indication |
| 123134652 | 12313465 | 2 | Product used for unknown indication |
| 123134652 | 12313465 | 3 | Product used for unknown indication |
| 123134652 | 12313465 | 4 | Product used for unknown indication |
| 123134652 | 12313465 | 5 | Product used for unknown indication |
| 123134652 | 12313465 | 6 | Product used for unknown indication |
| 123134652 | 12313465 | 7 | Product used for unknown indication |
| 123134652 | 12313465 | 8 | Product used for unknown indication |
| 123134652 | 12313465 | 9 | Product used for unknown indication |
| 123134652 | 12313465 | 10 | Product used for unknown indication |
| 123134652 | 12313465 | 11 | Product used for unknown indication |
| 123134652 | 12313465 | 12 | Product used for unknown indication |
| 123134652 | 12313465 | 13 | Embolism venous |
| 123134652 | 12313465 | 14 | Product used for unknown indication |
| 123134652 | 12313465 | 15 | Product used for unknown indication |
| 123134652 | 12313465 | 16 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123134652 | 12313465 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123134652 | 12313465 | Abortion induced | |
| 123134652 | 12313465 | Exposure during pregnancy | |
| 123134652 | 12313465 | Thrombosis | |
| 123134652 | 12313465 | Vena cava thrombosis |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |