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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125215171 | 12521517 | 1 | I | 201512 | 20160623 | 20160701 | 20160701 | EXP | US-JNJFOC-20160622822 | JANSSEN | 54.97 | YR | A | F | Y | 58.97000 | KG | 20160701 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125215171 | 12521517 | 1 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | 0 | 3 | MG/KG | LYOPHILIZED POWDER | |||||||
| 125215171 | 12521517 | 2 | PS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | 103772 | 3 | MG/KG | LYOPHILIZED POWDER | |||||||
| 125215171 | 12521517 | 3 | C | SALINE | SODIUM CHLORIDE | 1 | Unknown | 0 | UNKNOWN | ||||||||||
| 125215171 | 12521517 | 4 | C | XOLAIR | OMALIZUMAB | 1 | Unknown | 3 INJECTIONS EVERY OTHER WEEK | 0 | SOLUTION | |||||||||
| 125215171 | 12521517 | 5 | C | DEXILANT | DEXLANSOPRAZOLE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 125215171 | 12521517 | 6 | C | SOLU-MEDROL | METHYLPREDNISOLONE SODIUM SUCCINATE | 1 | Unknown | 0 | UNKNOWN | ||||||||||
| 125215171 | 12521517 | 7 | C | PREDNISONE. | PREDNISONE | 1 | Unknown | 125 | 0 | UNKNOWN |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125215171 | 12521517 | 1 | Colitis ulcerative |
| 125215171 | 12521517 | 2 | Colitis ulcerative |
| 125215171 | 12521517 | 3 | Premedication |
| 125215171 | 12521517 | 4 | Asthma |
| 125215171 | 12521517 | 5 | Oesophageal disorder |
| 125215171 | 12521517 | 6 | Premedication |
| 125215171 | 12521517 | 7 | Premedication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125215171 | 12521517 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125215171 | 12521517 | Hypersensitivity | |
| 125215171 | 12521517 | Infusion related reaction | |
| 125215171 | 12521517 | Malaise | |
| 125215171 | 12521517 | Oropharyngeal pain | |
| 125215171 | 12521517 | Rash | |
| 125215171 | 12521517 | Surgery | |
| 125215171 | 12521517 | Throat tightness | |
| 125215171 | 12521517 | Viral infection |
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 |
|---|---|---|---|---|---|---|
| 125215171 | 12521517 | 1 | 201512 | 0 | ||
| 125215171 | 12521517 | 2 | 2016 | 0 | ||
| 125215171 | 12521517 | 3 | 2016 | 0 | ||
| 125215171 | 12521517 | 6 | 2016 | 0 | ||
| 125215171 | 12521517 | 7 | 2016 | 0 |