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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 98304614 | 9830461 | 4 | F | 20101228 | 20160825 | 20140120 | 20160829 | EXP | FR-JNJFOC-20140104638 | JANSSEN | 84.00 | YR | E | M | Y | 90.00000 | KG | 20160829 | MD | FR | FR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 98304614 | 9830461 | 1 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | 2 AND 3RD INJECTION (DOSAGE FORM 10 MG/KG | Y | Y | 0 | 800 | MG | LYOPHILIZED POWDER | |||||
| 98304614 | 9830461 | 2 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | Y | 0 | LYOPHILIZED POWDER | ||||||||
| 98304614 | 9830461 | 3 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | 2 AND 3RD INJECTION (DOSAGE FORM 10 MG/KG | Y | Y | 0 | 800 | MG | LYOPHILIZED POWDER | |||||
| 98304614 | 9830461 | 4 | PS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | Y | 103772 | LYOPHILIZED POWDER | ||||||||
| 98304614 | 9830461 | 5 | C | SOTALOL. | SOTALOL | 1 | Unknown | 0 | 80 | MG | UNSPECIFIED | ||||||||
| 98304614 | 9830461 | 6 | C | AMLOR | AMLODIPINE BESYLATE | 1 | Unknown | 0 | 5 | MG | UNSPECIFIED | ||||||||
| 98304614 | 9830461 | 7 | C | SERETIDE | FLUTICASONE PROPIONATESALMETEROL XINAFOATE | 1 | Unknown | 0 | 500 | MG | UNSPECIFIED | ||||||||
| 98304614 | 9830461 | 8 | C | SPIRIVA | TIOTROPIUM BROMIDE MONOHYDRATE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 98304614 | 9830461 | 9 | C | PENTASA | MESALAMINE | 1 | Unknown | 0 | 3 | G | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 98304614 | 9830461 | 1 | Ankylosing spondylitis |
| 98304614 | 9830461 | 2 | Ankylosing spondylitis |
| 98304614 | 9830461 | 3 | Colitis ulcerative |
| 98304614 | 9830461 | 4 | Colitis ulcerative |
| 98304614 | 9830461 | 5 | Cardiac disorder |
| 98304614 | 9830461 | 6 | Cardiac disorder |
| 98304614 | 9830461 | 7 | Chronic obstructive pulmonary disease |
| 98304614 | 9830461 | 8 | Chronic obstructive pulmonary disease |
| 98304614 | 9830461 | 9 | Colitis ulcerative |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 98304614 | 9830461 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 98304614 | 9830461 | Bronchospasm | Bronchospasm |
| 98304614 | 9830461 | Infusion related reaction | Infusion related reaction |
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 |
|---|---|---|---|---|---|---|
| 98304614 | 9830461 | 1 | 20101228 | 20101229 | 0 | |
| 98304614 | 9830461 | 2 | 20101207 | 0 | ||
| 98304614 | 9830461 | 3 | 20101228 | 20101229 | 0 | |
| 98304614 | 9830461 | 4 | 20101207 | 0 |