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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 110928112 | 11092811 | 2 | F | 20150327 | 20160901 | 20150506 | 20160908 | EXP | BR-JNJFOC-20150423876 | JANSSEN | 37.57 | YR | A | F | Y | 0.00000 | 20160908 | CN | BR | BR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 110928112 | 11092811 | 1 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | N | 0 | LYOPHILIZED POWDER | ||||||||
| 110928112 | 11092811 | 2 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | N | 0 | LYOPHILIZED POWDER | ||||||||
| 110928112 | 11092811 | 3 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | N | 0 | LYOPHILIZED POWDER | ||||||||
| 110928112 | 11092811 | 4 | PS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | N | 103772 | LYOPHILIZED POWDER | ||||||||
| 110928112 | 11092811 | 5 | C | ALLURENE | DIENOGEST | 1 | Unknown | 0 | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 110928112 | 11092811 | 1 | Crohn's disease |
| 110928112 | 11092811 | 2 | Crohn's disease |
| 110928112 | 11092811 | 3 | Colitis |
| 110928112 | 11092811 | 4 | Colitis |
| 110928112 | 11092811 | 5 | Endometriosis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 110928112 | 11092811 | HO |
| 110928112 | 11092811 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 110928112 | 11092811 | Facial paralysis | |
| 110928112 | 11092811 | Herpes ophthalmic | |
| 110928112 | 11092811 | Nephrolithiasis | |
| 110928112 | 11092811 | Pain | |
| 110928112 | 11092811 | Pneumonia |
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 |
|---|---|---|---|---|---|---|
| 110928112 | 11092811 | 1 | 20150205 | 0 | ||
| 110928112 | 11092811 | 2 | 20140624 | 0 | ||
| 110928112 | 11092811 | 3 | 20140624 | 0 | ||
| 110928112 | 11092811 | 4 | 20150205 | 0 |