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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121425643 | 12142564 | 3 | F | 2016 | 20160819 | 20160303 | 20160831 | EXP | GB-ABBVIE-16K-167-1557182-00 | ABBVIE | 35.38 | YR | F | Y | 0.00000 | 20160831 | OT | COUNTRY NOT SPECIFIED | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121425643 | 12142564 | 1 | PS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | N | 1049349 | 125057 | 40 | MG | SOLUTION FOR INJECTION | QOW | |||||
| 121425643 | 12142564 | 2 | SS | HUMIRA | ADALIMUMAB | 1 | N | 1049349 | 125057 | ||||||||||
| 121425643 | 12142564 | 3 | C | LEFLUNOMIDE. | LEFLUNOMIDE | 1 | Oral | 0 | 10 | MG | QD | ||||||||
| 121425643 | 12142564 | 4 | C | PREDNISOLONE. | PREDNISOLONE | 1 | Oral | 0 | 5 | MG | QD | ||||||||
| 121425643 | 12142564 | 5 | C | IBUPROFEN. | IBUPROFEN | 1 | Oral | 0 | 400 | MG | BID | ||||||||
| 121425643 | 12142564 | 6 | C | PARACETAMOL | ACETAMINOPHEN | 1 | Oral | 0 | 1 | G | QID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 121425643 | 12142564 | 1 | Rheumatoid arthritis |
| 121425643 | 12142564 | 2 | Arthritis |
| 121425643 | 12142564 | 3 | Arthritis |
| 121425643 | 12142564 | 4 | Product used for unknown indication |
| 121425643 | 12142564 | 5 | Product used for unknown indication |
| 121425643 | 12142564 | 6 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 121425643 | 12142564 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 121425643 | 12142564 | Alopecia | |
| 121425643 | 12142564 | Anaphylactic reaction | |
| 121425643 | 12142564 | Contusion | |
| 121425643 | 12142564 | Epistaxis | |
| 121425643 | 12142564 | Hair growth abnormal | |
| 121425643 | 12142564 | Headache | |
| 121425643 | 12142564 | Mouth ulceration | |
| 121425643 | 12142564 | Nasal ulcer | |
| 121425643 | 12142564 | Paraesthesia | |
| 121425643 | 12142564 | Pruritus | |
| 121425643 | 12142564 | Rash | |
| 121425643 | 12142564 | Urticaria |
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 |
|---|---|---|---|---|---|---|
| 121425643 | 12142564 | 1 | 20160125 | 0 | ||
| 121425643 | 12142564 | 3 | 2014 | 0 | ||
| 121425643 | 12142564 | 4 | 2012 | 0 | ||
| 121425643 | 12142564 | 5 | 2007 | 0 |