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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125941421 | 12594142 | 1 | I | 20160711 | 20160726 | 20160726 | EXP | GB-AUROBINDO-AUR-APL-2016-09128 | AUROBINDO | 0.00 | M | Y | 0.00000 | 20160725 | OT | GB | GB |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125941421 | 12594142 | 1 | PS | Mirtazapine Film-coated Tablet | MIRTAZAPINE | 1 | Oral | UNK | U | U | 76921 | FILM-COATED TABLET | |||||||
| 125941421 | 12594142 | 2 | SS | AMITRIPTYLINE | AMITRIPTYLINE | 1 | Oral | UNK | U | U | 0 | TABLET | |||||||
| 125941421 | 12594142 | 3 | SS | SIMPONI | GOLIMUMAB | 1 | Subcutaneous | 50 MG, UNK | U | U | 0 | 50 | MG | SUSPENSION FOR INJECTION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125941421 | 12594142 | 1 | Product used for unknown indication |
| 125941421 | 12594142 | 2 | Product used for unknown indication |
| 125941421 | 12594142 | 3 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125941421 | 12594142 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125941421 | 12594142 | Depression | |
| 125941421 | 12594142 | Erectile dysfunction | |
| 125941421 | 12594142 | Headache | |
| 125941421 | 12594142 | Heart rate irregular | |
| 125941421 | 12594142 | Osteoarthritis | |
| 125941421 | 12594142 | Psoriatic arthropathy |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |