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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1161761411 | 11617614 | 11 | F | 2010 | 20160706 | 20151009 | 20160713 | EXP | CA-ABBVIE-15K-028-1475259-00 | ABBVIE | 28.84 | YR | M | Y | 46.00000 | KG | 20160713 | MD | COUNTRY NOT SPECIFIED | CA |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1161761411 | 11617614 | 1 | PS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | 6054523,6055115,6058740,6058854,606 | 125057 | 40 | MG | SOLUTION FOR INJECTION IN PRE-FILLED PEN | QOW | ||||||
| 1161761411 | 11617614 | 2 | SS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | 6054523,6055115,6058740,6058854,606 | 125057 | SOLUTION FOR INJECTION IN PRE-FILLED PEN | QOW | ||||||||
| 1161761411 | 11617614 | 3 | SS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | 6054523,6055115,6058740,6058854,606 | 125057 | SOLUTION FOR INJECTION IN PRE-FILLED PEN | |||||||||
| 1161761411 | 11617614 | 4 | SS | DILANTIN | PHENYTOIN | 1 | Unknown | Y | UNKNOWN | 0 | |||||||||
| 1161761411 | 11617614 | 5 | C | DEMEROL | MEPERIDINE HYDROCHLORIDE | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 1161761411 | 11617614 | 1 | Crohn's disease |
| 1161761411 | 11617614 | 4 | Seizure |
| 1161761411 | 11617614 | 5 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 1161761411 | 11617614 | HO |
| 1161761411 | 11617614 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 1161761411 | 11617614 | Brain neoplasm | |
| 1161761411 | 11617614 | Central nervous system lesion | |
| 1161761411 | 11617614 | Decreased appetite | |
| 1161761411 | 11617614 | Dizziness | |
| 1161761411 | 11617614 | Drug dose omission | |
| 1161761411 | 11617614 | Drug level decreased | |
| 1161761411 | 11617614 | Epilepsy | |
| 1161761411 | 11617614 | Head injury | |
| 1161761411 | 11617614 | Infection | |
| 1161761411 | 11617614 | Memory impairment | |
| 1161761411 | 11617614 | Seizure | |
| 1161761411 | 11617614 | Tongue injury | |
| 1161761411 | 11617614 | Vomiting |
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 |
|---|---|---|---|---|---|---|
| 1161761411 | 11617614 | 1 | 20080101 | 20150930 | 0 | |
| 1161761411 | 11617614 | 2 | 20151029 | 20160107 | 0 | |
| 1161761411 | 11617614 | 3 | 20160112 | 0 |