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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118894372 | 11889437 | 2 | F | 201506 | 20160908 | 20160105 | 20160916 | EXP | BR-ABBVIE-15K-020-1530561-00 | ABBVIE | 62.19 | YR | F | Y | 44.00000 | KG | 20160916 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118894372 | 11889437 | 1 | PS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | N | 46034XH01 | 125057 | 40 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | ||||||
| 118894372 | 11889437 | 2 | SS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | N | 46034XH01 | 125057 | 40 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | ||||||
| 118894372 | 11889437 | 3 | SS | METHOTREXATE. | METHOTREXATE | 1 | Unknown | N | UNKNOWN | 0 | TABLET | ||||||||
| 118894372 | 11889437 | 4 | SS | METHOTREXATE. | METHOTREXATE | 1 | Unknown | DOSAGE DECREASED | N | UNKNOWN | 0 | 2 | DF | TABLET | /wk | ||||
| 118894372 | 11889437 | 5 | C | VERAPAMIL | VERAPAMIL HYDROCHLORIDE | 1 | Oral | 0 | 80 | MG | TABLET | QD | |||||||
| 118894372 | 11889437 | 6 | C | VALSARTAN. | VALSARTAN | 1 | Oral | 0 | 1 | DF | TABLET | QD | |||||||
| 118894372 | 11889437 | 7 | C | CLORANA | HYDROCHLOROTHIAZIDE | 1 | Oral | 0 | 1 | DF | TABLET | QD | |||||||
| 118894372 | 11889437 | 8 | C | METICORTEN | PREDNISONE | 1 | Oral | 0 | 10 | MG | TABLET | QD | |||||||
| 118894372 | 11889437 | 9 | C | METICORTEN | PREDNISONE | 1 | Oral | 0 | 5 | MG | TABLET | QD | |||||||
| 118894372 | 11889437 | 10 | C | SYMBICORT | BUDESONIDEFORMOTEROL FUMARATE DIHYDRATE | 1 | Oral | DAILY DOSE: 1 PUFF ONCE OR TWICE | 0 | ||||||||||
| 118894372 | 11889437 | 11 | C | SYMBICORT | BUDESONIDEFORMOTEROL FUMARATE DIHYDRATE | 1 | 0 | ||||||||||||
| 118894372 | 11889437 | 12 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | Oral | 0 | TABLET | ||||||||||
| 118894372 | 11889437 | 13 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | 0 | ||||||||||||
| 118894372 | 11889437 | 14 | C | TECNOMET | METHOTREXATE | 1 | Oral | 0 | TABLET | /wk |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 118894372 | 11889437 | 1 | Rheumatoid arthritis |
| 118894372 | 11889437 | 3 | Product used for unknown indication |
| 118894372 | 11889437 | 5 | Hypertension |
| 118894372 | 11889437 | 6 | Hypertension |
| 118894372 | 11889437 | 7 | Fluid retention |
| 118894372 | 11889437 | 8 | Rheumatic disorder |
| 118894372 | 11889437 | 10 | Bronchitis |
| 118894372 | 11889437 | 11 | Dyspnoea |
| 118894372 | 11889437 | 12 | Gastric disorder |
| 118894372 | 11889437 | 13 | Prophylaxis |
| 118894372 | 11889437 | 14 | Rheumatic disorder |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 118894372 | 11889437 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 118894372 | 11889437 | Cataract | |
| 118894372 | 11889437 | Corneal graft rejection | |
| 118894372 | 11889437 | Face injury | |
| 118894372 | 11889437 | Foot deformity | |
| 118894372 | 11889437 | Gait disturbance | |
| 118894372 | 11889437 | Headache | |
| 118894372 | 11889437 | Hyperkeratosis | |
| 118894372 | 11889437 | Liver disorder | |
| 118894372 | 11889437 | Localised infection | |
| 118894372 | 11889437 | Lower limb fracture | |
| 118894372 | 11889437 | Rash pustular | |
| 118894372 | 11889437 | Vision blurred | |
| 118894372 | 11889437 | 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 |
|---|---|---|---|---|---|---|
| 118894372 | 11889437 | 1 | 20150130 | 201511 | 0 | |
| 118894372 | 11889437 | 5 | 201511 | 0 | ||
| 118894372 | 11889437 | 6 | 201509 | 0 | ||
| 118894372 | 11889437 | 7 | 2013 | 0 | ||
| 118894372 | 11889437 | 9 | 1998 | 0 | ||
| 118894372 | 11889437 | 10 | 2008 | 0 | ||
| 118894372 | 11889437 | 12 | 2008 | 0 | ||
| 118894372 | 11889437 | 14 | 201603 | 0 |