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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117839103 | 11783910 | 3 | F | 2010 | 20160711 | 20151128 | 20160721 | EXP | US-ABBVIE-15K-163-1506380-00 | ABBVIE | 0.00 | M | Y | 81.72000 | KG | 20160721 | MD | COUNTRY NOT SPECIFIED | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117839103 | 11783910 | 1 | PS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | U | 1045620,1053315 | 125057 | 40 | MG | SOLUTION FOR INJECTION IN PRE-FILLED PEN | QOW | |||||
| 117839103 | 11783910 | 2 | SS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | U | 1045620,1053315 | 125057 | 40 | MG | SOLUTION FOR INJECTION IN PRE-FILLED PEN | /wk | |||||
| 117839103 | 11783910 | 3 | C | MORPHINE | MORPHINE | 1 | 0 | ||||||||||||
| 117839103 | 11783910 | 4 | C | OXYCODONE | OXYCODONE | 1 | 0 | ||||||||||||
| 117839103 | 11783910 | 5 | C | GABAPENTIN. | GABAPENTIN | 1 | 0 | ||||||||||||
| 117839103 | 11783910 | 6 | C | LIPITOR | ATORVASTATIN CALCIUM | 1 | 0 | ||||||||||||
| 117839103 | 11783910 | 7 | C | NABUMETONE. | NABUMETONE | 1 | 0 | ||||||||||||
| 117839103 | 11783910 | 8 | C | NABUMETONE. | NABUMETONE | 1 | 0 | ||||||||||||
| 117839103 | 11783910 | 9 | C | LIDOCAINE. | LIDOCAINE | 1 | Topical | 0 | |||||||||||
| 117839103 | 11783910 | 10 | C | CHLORAZEPAM | 2 | 0 | |||||||||||||
| 117839103 | 11783910 | 11 | C | ROBAXIN | METHOCARBAMOL | 1 | 0 | ||||||||||||
| 117839103 | 11783910 | 12 | C | PREDNISONE. | PREDNISONE | 1 | 0 | ||||||||||||
| 117839103 | 11783910 | 13 | C | ATORVASTATIN | ATORVASTATIN | 1 | 0 | ||||||||||||
| 117839103 | 11783910 | 14 | C | VITAMIN D | CHOLECALCIFEROL | 1 | 0 | ||||||||||||
| 117839103 | 11783910 | 15 | C | METHOTREXATE. | METHOTREXATE | 1 | 0 | ||||||||||||
| 117839103 | 11783910 | 16 | C | FOLIC ACID. | FOLIC ACID | 1 | 0 | ||||||||||||
| 117839103 | 11783910 | 17 | C | LEVOTHYROXINE. | LEVOTHYROXINE | 1 | 0 | ||||||||||||
| 117839103 | 11783910 | 18 | C | ASPIRIN. | ASPIRIN | 1 | 0 | 81 | MG | ||||||||||
| 117839103 | 11783910 | 19 | C | PREDNISONE. | PREDNISONE | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 117839103 | 11783910 | 1 | Ankylosing spondylitis |
| 117839103 | 11783910 | 3 | Pain |
| 117839103 | 11783910 | 4 | Pain |
| 117839103 | 11783910 | 5 | Product used for unknown indication |
| 117839103 | 11783910 | 6 | Product used for unknown indication |
| 117839103 | 11783910 | 7 | Ankylosing spondylitis |
| 117839103 | 11783910 | 8 | Inflammation |
| 117839103 | 11783910 | 9 | Pain |
| 117839103 | 11783910 | 10 | Product used for unknown indication |
| 117839103 | 11783910 | 11 | Hypotonia |
| 117839103 | 11783910 | 12 | Ankylosing spondylitis |
| 117839103 | 11783910 | 13 | Blood cholesterol increased |
| 117839103 | 11783910 | 14 | Product used for unknown indication |
| 117839103 | 11783910 | 15 | Product used for unknown indication |
| 117839103 | 11783910 | 16 | Product used for unknown indication |
| 117839103 | 11783910 | 17 | Product used for unknown indication |
| 117839103 | 11783910 | 18 | Product used for unknown indication |
| 117839103 | 11783910 | 19 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 117839103 | 11783910 | OT |
| 117839103 | 11783910 | HO |
| 117839103 | 11783910 | DS |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 117839103 | 11783910 | Ankylosing spondylitis | |
| 117839103 | 11783910 | Bacterial infection | |
| 117839103 | 11783910 | Blister | |
| 117839103 | 11783910 | Blister infected | |
| 117839103 | 11783910 | Blood blister | |
| 117839103 | 11783910 | Cellulitis | |
| 117839103 | 11783910 | Cervical radiculopathy | |
| 117839103 | 11783910 | Gangrene | |
| 117839103 | 11783910 | Headache | |
| 117839103 | 11783910 | Hip arthroplasty | |
| 117839103 | 11783910 | Infection | |
| 117839103 | 11783910 | Localised infection | |
| 117839103 | 11783910 | Musculoskeletal disorder | |
| 117839103 | 11783910 | Nerve injury | |
| 117839103 | 11783910 | Peripheral swelling | |
| 117839103 | 11783910 | Pruritus | |
| 117839103 | 11783910 | Sepsis | |
| 117839103 | 11783910 | Skin injury | |
| 117839103 | 11783910 | Spinal column stenosis | |
| 117839103 | 11783910 | Spinal operation | |
| 117839103 | 11783910 | Wound infection |
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 |
|---|---|---|---|---|---|---|
| 117839103 | 11783910 | 1 | 2009 | 2013 | 0 | |
| 117839103 | 11783910 | 2 | 2013 | 0 |