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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125706081 | 12570608 | 1 | I | 20160708 | 20160719 | 20160719 | EXP | GB-JNJFOC-20160707505 | JANSSEN | 35.00 | YR | A | F | Y | 0.00000 | 20160719 | MD | GB | GB |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125706081 | 12570608 | 1 | PS | INFLIXIMAB, RECOMBINANT | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | U | U | 103772 | LYOPHILIZED POWDER | ||||||||
| 125706081 | 12570608 | 2 | SS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | 0 | UNSPECIFIED | ||||||||||
| 125706081 | 12570608 | 3 | SS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | /0.8ML | 0 | 40 | MG | UNSPECIFIED | QOW | ||||||
| 125706081 | 12570608 | 4 | SS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | 0 | UNSPECIFIED | ||||||||||
| 125706081 | 12570608 | 5 | SS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | 0 | UNSPECIFIED | ||||||||||
| 125706081 | 12570608 | 6 | SS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | /0.8ML | 0 | 40 | MG | UNSPECIFIED | QOW | ||||||
| 125706081 | 12570608 | 7 | SS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | 0 | UNSPECIFIED | ||||||||||
| 125706081 | 12570608 | 8 | SS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | 0 | UNSPECIFIED | ||||||||||
| 125706081 | 12570608 | 9 | SS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | /0.8ML | 0 | 40 | MG | UNSPECIFIED | QOW | ||||||
| 125706081 | 12570608 | 10 | SS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | 0 | UNSPECIFIED | ||||||||||
| 125706081 | 12570608 | 11 | SS | METHOTREXATE. | METHOTREXATE | 1 | Unknown | U | 0 | 5 | MG | UNSPECIFIED | /wk |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125706081 | 12570608 | 1 | Product used for unknown indication |
| 125706081 | 12570608 | 2 | Arthritis |
| 125706081 | 12570608 | 3 | Arthritis |
| 125706081 | 12570608 | 4 | Arthritis |
| 125706081 | 12570608 | 5 | Psoriasis |
| 125706081 | 12570608 | 6 | Psoriasis |
| 125706081 | 12570608 | 7 | Psoriasis |
| 125706081 | 12570608 | 8 | Colitis |
| 125706081 | 12570608 | 9 | Colitis |
| 125706081 | 12570608 | 10 | Colitis |
| 125706081 | 12570608 | 11 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125706081 | 12570608 | OT |
| 125706081 | 12570608 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125706081 | 12570608 | Condition aggravated | |
| 125706081 | 12570608 | Lupus-like syndrome |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |