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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127335791 | 12733579 | 1 | I | 20160829 | 20160912 | 20160912 | EXP | NO-AUROBINDO-AUR-APL-2016-11308 | AUROBINDO | 51.00 | YR | F | Y | 0.00000 | 20160912 | CN | NO | NO |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127335791 | 12733579 | 1 | PS | NAPROXEN. | NAPROXEN | 1 | Unknown | U | U | 200629 | |||||||||
| 127335791 | 12733579 | 2 | SS | ESOMEPRAZOLE | ESOMEPRAZOLE | 1 | Unknown | U | U | 0 | |||||||||
| 127335791 | 12733579 | 3 | SS | XARELTO | RIVAROXABAN | 1 | Unknown | U | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127335791 | 12733579 | 1 | Product used for unknown indication |
| 127335791 | 12733579 | 2 | Product used for unknown indication |
| 127335791 | 12733579 | 3 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127335791 | 12733579 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127335791 | 12733579 | Arthralgia | |
| 127335791 | 12733579 | Back pain | |
| 127335791 | 12733579 | Bone graft | |
| 127335791 | 12733579 | Cervical vertebral fracture | |
| 127335791 | 12733579 | Deep vein thrombosis | |
| 127335791 | 12733579 | Extradural haematoma | |
| 127335791 | 12733579 | Fall | |
| 127335791 | 12733579 | Fibrin D dimer increased | |
| 127335791 | 12733579 | Joint swelling | |
| 127335791 | 12733579 | Limb discomfort | |
| 127335791 | 12733579 | Neurosurgery | |
| 127335791 | 12733579 | Osteosynthesis | |
| 127335791 | 12733579 | Spinal decompression | |
| 127335791 | 12733579 | Vertebral column mass |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |