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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 110442782 | 11044278 | 2 | F | 20150408 | 20160810 | 20150417 | 20160818 | EXP | CA-JNJFOC-20150409092 | JANSSEN | 51.54 | YR | A | F | Y | 99.70000 | KG | 20160818 | CN | CA | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 110442782 | 11044278 | 1 | PS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | GAM08013 | 103772 | 500 | MG | LYOPHILIZED POWDER | ||||||
| 110442782 | 11044278 | 2 | C | METHOTREXATE. | METHOTREXATE | 1 | Oral | 8 TABS | 0 | 20 | MG | TABLET | /wk | ||||||
| 110442782 | 11044278 | 3 | C | VENLAFAXINE | VENLAFAXINE HYDROCHLORIDE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 110442782 | 11044278 | 4 | C | RAMIPRIL. | RAMIPRIL | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 110442782 | 11044278 | 5 | C | LEVOTHYROXINE SODIUM. | LEVOTHYROXINE SODIUM | 1 | Unknown | U | 0 | UNSPECIFIED | |||||||||
| 110442782 | 11044278 | 6 | C | METFORMINE | METFORMIN HYDROCHLORIDE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 110442782 | 11044278 | 7 | C | FOLIC ACID. | FOLIC ACID | 1 | Unknown | 0 | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 110442782 | 11044278 | 1 | Crohn's disease |
| 110442782 | 11044278 | 2 | Crohn's disease |
| 110442782 | 11044278 | 3 | Hot flush |
| 110442782 | 11044278 | 4 | Hypertension |
| 110442782 | 11044278 | 5 | Hypothyroidism |
| 110442782 | 11044278 | 6 | Diabetes mellitus |
| 110442782 | 11044278 | 7 | Prophylaxis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 110442782 | 11044278 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 110442782 | 11044278 | Abdominal pain | |
| 110442782 | 11044278 | Frequent bowel movements | |
| 110442782 | 11044278 | General physical health deterioration | |
| 110442782 | 11044278 | Hypothyroidism | |
| 110442782 | 11044278 | Off label use | |
| 110442782 | 11044278 | Product use issue | |
| 110442782 | 11044278 | Thyroid cancer |
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 |
|---|---|---|---|---|---|---|
| 110442782 | 11044278 | 1 | 200905 | 0 | ||
| 110442782 | 11044278 | 2 | 2008 | 0 |