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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 120610852 | 12061085 | 2 | F | 20110824 | 20160805 | 20160210 | 20160812 | EXP | BR-ABBVIE-16K-020-1554327-00 | ABBVIE | 56.43 | YR | F | Y | 78.00000 | KG | 20160812 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 120610852 | 12061085 | 1 | PS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | UNKNOWN | 125057 | 40 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | |||||||
| 120610852 | 12061085 | 2 | C | METHOTREXATE. | METHOTREXATE | 1 | Oral | 0 | 2 | DF | TABLET | /wk | |||||||
| 120610852 | 12061085 | 3 | C | FOLIC ACID. | FOLIC ACID | 1 | Oral | 0 | 1 | DF | TABLET | /wk | |||||||
| 120610852 | 12061085 | 4 | C | FOLIC ACID. | FOLIC ACID | 1 | 0 | ||||||||||||
| 120610852 | 12061085 | 5 | C | FOLIC ACID. | FOLIC ACID | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 120610852 | 12061085 | 1 | Ankylosing spondylitis |
| 120610852 | 12061085 | 2 | Spondylitis |
| 120610852 | 12061085 | 3 | Spondylitis |
| 120610852 | 12061085 | 4 | Gastrointestinal injury |
| 120610852 | 12061085 | 5 | Prophylaxis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 120610852 | 12061085 | HO |
| 120610852 | 12061085 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 120610852 | 12061085 | Bile duct stenosis | |
| 120610852 | 12061085 | Feeling hot | |
| 120610852 | 12061085 | Finger deformity | |
| 120610852 | 12061085 | Hypersensitivity | |
| 120610852 | 12061085 | Inflammation | |
| 120610852 | 12061085 | Injection site erythema | |
| 120610852 | 12061085 | Injection site pain | |
| 120610852 | 12061085 | Injection site papule | |
| 120610852 | 12061085 | Injection site swelling | |
| 120610852 | 12061085 | Injection site warmth | |
| 120610852 | 12061085 | Intestinal obstruction | |
| 120610852 | 12061085 | Local swelling | |
| 120610852 | 12061085 | Mouth swelling | |
| 120610852 | 12061085 | Neck pain | |
| 120610852 | 12061085 | Oral pruritus | |
| 120610852 | 12061085 | Pain | |
| 120610852 | 12061085 | Pruritus | |
| 120610852 | 12061085 | Stomatitis | |
| 120610852 | 12061085 | Swelling face | |
| 120610852 | 12061085 | Wound |
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 |
|---|---|---|---|---|---|---|
| 120610852 | 12061085 | 1 | 20110824 | 0 | ||
| 120610852 | 12061085 | 2 | 2011 | 0 | ||
| 120610852 | 12061085 | 3 | 2011 | 0 |