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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 119380536 | 11938053 | 6 | F | 20130920 | 20160728 | 20160122 | 20160801 | EXP | JP-ABBVIE-16K-087-1542987-00 | ABBVIE | 58.38 | YR | M | Y | 57.50000 | KG | 20160801 | MD | JP | JP |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 119380536 | 11938053 | 1 | PS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | UNKNOWN | 125057 | 40 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | QOW | ||||||
| 119380536 | 11938053 | 2 | SS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | UNKNOWN | 125057 | 40 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | Q3W | ||||||
| 119380536 | 11938053 | 3 | SS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | UNKNOWN | 125057 | 40 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | |||||||
| 119380536 | 11938053 | 4 | SS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | UNKNOWN | 125057 | 40 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | |||||||
| 119380536 | 11938053 | 5 | SS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | UNKNOWN | 125057 | 40 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | |||||||
| 119380536 | 11938053 | 6 | SS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | UNKNOWN | 125057 | 40 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | QOW | ||||||
| 119380536 | 11938053 | 7 | SS | RHEUMATREX | METHOTREXATE SODIUM | 1 | Oral | Y | UNKNOWN | 0 | 6 | MG | CAPSULE | /wk | |||||
| 119380536 | 11938053 | 8 | C | CALCIPOTRIOL HYDRATE/BETAMETHASONE DIPROPIONATE | 2 | Topical | 0 | .5 | G | OINTMENT | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 119380536 | 11938053 | 1 | Psoriasis |
| 119380536 | 11938053 | 7 | Arthralgia |
| 119380536 | 11938053 | 8 | Psoriasis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 119380536 | 11938053 | HO |
| 119380536 | 11938053 | DS |
| 119380536 | 11938053 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 119380536 | 11938053 | Arthralgia | |
| 119380536 | 11938053 | Bone erosion | |
| 119380536 | 11938053 | Cardiac murmur | |
| 119380536 | 11938053 | Coagulopathy | |
| 119380536 | 11938053 | Diverticulitis | |
| 119380536 | 11938053 | Endocarditis | |
| 119380536 | 11938053 | Immunodeficiency | |
| 119380536 | 11938053 | Impaired healing | |
| 119380536 | 11938053 | Infective aneurysm | |
| 119380536 | 11938053 | Inguinal hernia | |
| 119380536 | 11938053 | Joint swelling | |
| 119380536 | 11938053 | Mitral valve incompetence | |
| 119380536 | 11938053 | Mitral valve prolapse | |
| 119380536 | 11938053 | Nasopharyngitis | |
| 119380536 | 11938053 | Rheumatoid factor positive | |
| 119380536 | 11938053 | Subarachnoid haemorrhage |
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 |
|---|---|---|---|---|---|---|
| 119380536 | 11938053 | 1 | 20130305 | 20140619 | 0 | |
| 119380536 | 11938053 | 2 | 20140710 | 20150618 | 0 | |
| 119380536 | 11938053 | 3 | 20150730 | 20150903 | 0 | |
| 119380536 | 11938053 | 4 | 20150917 | 20151027 | 0 | |
| 119380536 | 11938053 | 5 | 20151028 | 20151223 | 0 | |
| 119380536 | 11938053 | 6 | 20151224 | 20160107 | 0 | |
| 119380536 | 11938053 | 7 | 20151224 | 20160112 | 0 | |
| 119380536 | 11938053 | 8 | 20150917 | 20160112 | 0 |