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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125464811 | 12546481 | 1 | I | 2016 | 20160630 | 20160711 | 20160711 | EXP | BR-ABBVIE-16K-020-1667312-00 | ABBVIE | 0.00 | F | Y | 0.00000 | 20160711 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125464811 | 12546481 | 1 | PS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | UNKNOWN | 125057 | 40 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | |||||||
| 125464811 | 12546481 | 2 | SS | MORPHINE | MORPHINE | 1 | Unknown | U | UNKNOWN | 0 | |||||||||
| 125464811 | 12546481 | 3 | C | NEOZINE | LEVOMEPROMAZINE | 1 | Oral | 0 | TABLET | ||||||||||
| 125464811 | 12546481 | 4 | C | DIAZEPAM. | DIAZEPAM | 1 | Oral | 0 | TABLET | ||||||||||
| 125464811 | 12546481 | 5 | C | CYCLOBENZAPRINE | CYCLOBENZAPRINE | 1 | Oral | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125464811 | 12546481 | 1 | Ankylosing spondylitis |
| 125464811 | 12546481 | 2 | Product used for unknown indication |
| 125464811 | 12546481 | 3 | Sleep disorder therapy |
| 125464811 | 12546481 | 4 | Sedative therapy |
| 125464811 | 12546481 | 5 | Pain |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125464811 | 12546481 | DS |
| 125464811 | 12546481 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125464811 | 12546481 | Abdominal pain upper | |
| 125464811 | 12546481 | Arthralgia | |
| 125464811 | 12546481 | Back pain | |
| 125464811 | 12546481 | Blood cholesterol increased | |
| 125464811 | 12546481 | Drug effect decreased | |
| 125464811 | 12546481 | Dyspnoea | |
| 125464811 | 12546481 | Headache | |
| 125464811 | 12546481 | Injury | |
| 125464811 | 12546481 | Mobility decreased | |
| 125464811 | 12546481 | Muscle spasms | |
| 125464811 | 12546481 | Musculoskeletal pain | |
| 125464811 | 12546481 | Musculoskeletal stiffness | |
| 125464811 | 12546481 | Nasal pruritus | |
| 125464811 | 12546481 | Pain | |
| 125464811 | 12546481 | Pain in extremity | |
| 125464811 | 12546481 | Peripheral swelling | |
| 125464811 | 12546481 | Protein total increased | |
| 125464811 | 12546481 | Rhinitis | |
| 125464811 | 12546481 | Sensitivity to weather change | |
| 125464811 | 12546481 | Spleen scan abnormal |
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 |
|---|---|---|---|---|---|---|
| 125464811 | 12546481 | 1 | 20160301 | 0 | ||
| 125464811 | 12546481 | 3 | 201603 | 0 | ||
| 125464811 | 12546481 | 5 | 2015 | 0 |