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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125944761 | 12594476 | 1 | I | 201604 | 20160713 | 20160726 | 20160726 | EXP | GB-AUROBINDO-AUR-APL-2016-09296 | AUROBINDO | 0.00 | Y | 0.00000 | 20160726 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125944761 | 12594476 | 1 | PS | RAMIPRIL. | RAMIPRIL | 1 | Unknown | DOSAGE FORM: UNSPECIFIED | U | U | 91604 | ||||||||
| 125944761 | 12594476 | 2 | SS | SIMPONI | GOLIMUMAB | 1 | Subcutaneous | 50 MG, UNK | UNKNOWN | 0 | 50 | MG | SOLUTION FOR INJECTION | ||||||
| 125944761 | 12594476 | 3 | C | CETIRIZINE | CETIRIZINE HYDROCHLORIDE | 1 | Unknown | DOSAGE FORM: UNSPECIFIED | U | 0 | |||||||||
| 125944761 | 12594476 | 4 | C | DICLOFENAC | DICLOFENAC | 1 | Unknown | 50 MG, UNK | U | 0 | 50 | MG | |||||||
| 125944761 | 12594476 | 5 | C | FOLIC ACID. | FOLIC ACID | 1 | Unknown | 5 MG, UNK | U | 0 | 5 | MG | |||||||
| 125944761 | 12594476 | 6 | C | METHOTREXATE. | METHOTREXATE | 1 | Unknown | 20 MG, UNK | U | 0 | 20 | MG | |||||||
| 125944761 | 12594476 | 7 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | Unknown | DOSAGE FORM: UNSPECIFIED | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125944761 | 12594476 | 1 | Product used for unknown indication |
| 125944761 | 12594476 | 2 | Psoriatic arthropathy |
| 125944761 | 12594476 | 3 | Seasonal allergy |
| 125944761 | 12594476 | 4 | Pain |
| 125944761 | 12594476 | 5 | Product used for unknown indication |
| 125944761 | 12594476 | 6 | Psoriatic arthropathy |
| 125944761 | 12594476 | 7 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125944761 | 12594476 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125944761 | 12594476 | Adenovirus infection | |
| 125944761 | 12594476 | Cough | |
| 125944761 | 12594476 | Fatigue | |
| 125944761 | 12594476 | Hyperkalaemia | |
| 125944761 | 12594476 | Influenza like illness |
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 |
|---|---|---|---|---|---|---|
| 125944761 | 12594476 | 2 | 201603 | 0 | ||
| 125944761 | 12594476 | 5 | 20110310 | 0 | ||
| 125944761 | 12594476 | 6 | 20110310 | 0 |