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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126215931 | 12621593 | 1 | I | 201602 | 20160720 | 20160804 | 20160804 | EXP | US-JNJFOC-20160719038 | JOHNSON AND JOHNSON | 17.06 | YR | T | F | Y | 0.00000 | 20160804 | CN | US | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126215931 | 12621593 | 1 | PS | MOTRIN | IBUPROFEN | 1 | Unknown | U | U | 19012 | UNSPECIFIED | ||||||||
| 126215931 | 12621593 | 2 | SS | MOTRIN | IBUPROFEN | 1 | Unknown | RECEIVED HIGH DOSES OF IBUPROFEN | U | U | 19012 | UNSPECIFIED | |||||||
| 126215931 | 12621593 | 3 | SS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | DOSE (40 MG, 1) | 0 | 40 | MG | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126215931 | 12621593 | 2 | Back injury |
| 126215931 | 12621593 | 3 | Crohn's disease |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126215931 | 12621593 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126215931 | 12621593 | Abdominal pain | |
| 126215931 | 12621593 | Constipation | |
| 126215931 | 12621593 | Decreased appetite | |
| 126215931 | 12621593 | Diarrhoea | |
| 126215931 | 12621593 | Gastrointestinal haemorrhage | |
| 126215931 | 12621593 | Insomnia | |
| 126215931 | 12621593 | Rectal haemorrhage | |
| 126215931 | 12621593 | Weight decreased |
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 |
|---|---|---|---|---|---|---|
| 126215931 | 12621593 | 3 | 201512 | 0 |