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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118811534 | 11881153 | 4 | F | 20160229 | 20160720 | 20151231 | 20160726 | EXP | US-UCBSA-2015042925 | UCB | 78.00 | YR | F | Y | 0.00000 | 20160727 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118811534 | 11881153 | 1 | PS | CIMZIA | CERTOLIZUMAB PEGOL | 1 | Subcutaneous | STRENGTH-200 MG/ML, PFS, 400 MG, EV 4 WEEKS | U | U | 125160 | 400 | MG | SOLUTION FOR INJECTION | |||||
| 118811534 | 11881153 | 2 | C | ALTACE | RAMIPRIL | 1 | UNK | U | U | 0 | |||||||||
| 118811534 | 11881153 | 3 | C | ASPIRIN. | ASPIRIN | 1 | UNK | U | U | 0 | |||||||||
| 118811534 | 11881153 | 4 | C | CELEXA | CITALOPRAM HYDROBROMIDE | 1 | UNK | U | U | 0 | |||||||||
| 118811534 | 11881153 | 5 | C | CIPRO | CIPROFLOXACIN HYDROCHLORIDE | 1 | UNK | U | U | 0 | |||||||||
| 118811534 | 11881153 | 6 | C | FLONASE | FLUTICASONE PROPIONATE | 1 | UNK | U | U | 0 | |||||||||
| 118811534 | 11881153 | 7 | C | Vancomycin hcl | VANCOMYCIN HYDROCHLORIDE | 1 | UNK | U | U | 0 | |||||||||
| 118811534 | 11881153 | 8 | C | VITAMIN D | CHOLECALCIFEROL | 1 | UNK | U | U | 0 | |||||||||
| 118811534 | 11881153 | 9 | C | XARELTO | RIVAROXABAN | 1 | UNK | N | U | 0 | |||||||||
| 118811534 | 11881153 | 10 | C | ZOCOR | SIMVASTATIN | 1 | UNK | U | U | 0 | |||||||||
| 118811534 | 11881153 | 11 | C | Hypromellose | HYPROMELLOSES | 1 | UNK | U | U | 0 | |||||||||
| 118811534 | 11881153 | 12 | C | Metformin hcl | METFORMIN HYDROCHLORIDE | 1 | UNK | U | U | 0 | |||||||||
| 118811534 | 11881153 | 13 | C | VOLTAREN | DICLOFENAC SODIUM | 1 | UNK | U | 0 | ||||||||||
| 118811534 | 11881153 | 14 | C | LOZOL | INDAPAMIDE | 1 | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 118811534 | 11881153 | 1 | Crohn's disease |
| 118811534 | 11881153 | 2 | Product used for unknown indication |
| 118811534 | 11881153 | 3 | Product used for unknown indication |
| 118811534 | 11881153 | 4 | Product used for unknown indication |
| 118811534 | 11881153 | 5 | Product used for unknown indication |
| 118811534 | 11881153 | 6 | Product used for unknown indication |
| 118811534 | 11881153 | 7 | Product used for unknown indication |
| 118811534 | 11881153 | 8 | Product used for unknown indication |
| 118811534 | 11881153 | 9 | Product used for unknown indication |
| 118811534 | 11881153 | 10 | Product used for unknown indication |
| 118811534 | 11881153 | 11 | Product used for unknown indication |
| 118811534 | 11881153 | 12 | Product used for unknown indication |
| 118811534 | 11881153 | 13 | Product used for unknown indication |
| 118811534 | 11881153 | 14 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 118811534 | 11881153 | HO |
| 118811534 | 11881153 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 118811534 | 11881153 | Alopecia | |
| 118811534 | 11881153 | Cervical vertebral fracture | |
| 118811534 | 11881153 | Clostridium difficile infection | |
| 118811534 | 11881153 | Contusion | |
| 118811534 | 11881153 | Depressed mood | |
| 118811534 | 11881153 | Fall | |
| 118811534 | 11881153 | Sinusitis | |
| 118811534 | 11881153 | Thrombosis |
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 |
|---|---|---|---|---|---|---|
| 118811534 | 11881153 | 9 | 20151022 | 20160220 | 0 |