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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121662972 | 12166297 | 2 | F | 2014 | 20160624 | 20160309 | 20160701 | EXP | BR-ABBVIE-16K-020-1575573-00 | ABBVIE | 0.00 | F | Y | 59.00000 | KG | 20160701 | CN | COUNTRY NOT SPECIFIED | BR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121662972 | 12166297 | 1 | PS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | UNKNOWN | 125057 | 40 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | |||||||
| 121662972 | 12166297 | 2 | SS | ISONIAZID. | ISONIAZID | 1 | Oral | UNKNOWN | 0 | TABLET | |||||||||
| 121662972 | 12166297 | 3 | C | LEFLUNOMIDE. | LEFLUNOMIDE | 1 | Oral | 0 | 1 | DF | TABLET | ||||||||
| 121662972 | 12166297 | 4 | C | METHOTREXATE. | METHOTREXATE | 1 | Oral | 0 | 2 | DF | TABLET | /wk | |||||||
| 121662972 | 12166297 | 5 | C | FOLIC ACID. | FOLIC ACID | 1 | Oral | 0 | 1 | DF | TABLET | /wk | |||||||
| 121662972 | 12166297 | 6 | C | IBUPROFEN. | IBUPROFEN | 1 | Oral | 2 TABLETS PER DAY, AS NEEDED | 0 | TABLET | |||||||||
| 121662972 | 12166297 | 7 | C | PARACETAMOL | ACETAMINOPHEN | 1 | Oral | 2 TABLETS PER DAY, AS NEEDED | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 121662972 | 12166297 | 1 | Rheumatoid arthritis |
| 121662972 | 12166297 | 2 | Product used for unknown indication |
| 121662972 | 12166297 | 3 | Arthritis |
| 121662972 | 12166297 | 4 | Arthritis |
| 121662972 | 12166297 | 5 | Anaemia prophylaxis |
| 121662972 | 12166297 | 6 | Pain |
| 121662972 | 12166297 | 7 | Pain |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 121662972 | 12166297 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 121662972 | 12166297 | Abdominal pain upper | |
| 121662972 | 12166297 | Cataract | |
| 121662972 | 12166297 | Corneal perforation | |
| 121662972 | 12166297 | Gastric disorder | |
| 121662972 | 12166297 | Gastric mucosal lesion | |
| 121662972 | 12166297 | Ocular hyperaemia | |
| 121662972 | 12166297 | Ulcerative keratitis | |
| 121662972 | 12166297 | Visual impairment |
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 |
|---|---|---|---|---|---|---|
| 121662972 | 12166297 | 1 | 20130101 | 2013 | 0 | |
| 121662972 | 12166297 | 2 | 201508 | 20160229 | 0 | |
| 121662972 | 12166297 | 3 | 201511 | 0 | ||
| 121662972 | 12166297 | 4 | 2015 | 0 | ||
| 121662972 | 12166297 | 5 | 2015 | 0 |