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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124802172 | 12480217 | 2 | F | 2016 | 20160712 | 20160620 | 20160718 | EXP | US-JNJFOC-20160527539 | JANSSEN | 86.46 | YR | E | M | Y | 88.00000 | KG | 20160718 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124802172 | 12480217 | 1 | PS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | N | 103772 | LYOPHILIZED POWDER | ||||||||
| 124802172 | 12480217 | 2 | SS | PACERONE | AMIODARONE HYDROCHLORIDE | 1 | Unknown | Y | 0 | UNSPECIFIED | |||||||||
| 124802172 | 12480217 | 3 | C | BUDESONIDE. | BUDESONIDE | 1 | Unknown | 0 | 9 | MG | UNSPECIFIED | ||||||||
| 124802172 | 12480217 | 4 | C | PENTASA | MESALAMINE | 1 | Unknown | 0 | 1 | MG | UNSPECIFIED | QID | |||||||
| 124802172 | 12480217 | 5 | C | BENICAR | OLMESARTAN MEDOXOMIL | 1 | Unknown | 0 | 40 | MG | UNSPECIFIED | ||||||||
| 124802172 | 12480217 | 6 | C | HYDROCHLOROTHIAZIDE. | HYDROCHLOROTHIAZIDE | 1 | Unknown | 0 | 25 | MG | UNSPECIFIED | ||||||||
| 124802172 | 12480217 | 7 | C | SPIRIVA | TIOTROPIUM BROMIDE MONOHYDRATE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 124802172 | 12480217 | 8 | C | ADVAIR HFA | FLUTICASONE PROPIONATESALMETEROL XINAFOATE | 1 | Unknown | 0 | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124802172 | 12480217 | 1 | Crohn's disease |
| 124802172 | 12480217 | 2 | Product used for unknown indication |
| 124802172 | 12480217 | 3 | Crohn's disease |
| 124802172 | 12480217 | 4 | Crohn's disease |
| 124802172 | 12480217 | 5 | Hypertension |
| 124802172 | 12480217 | 6 | Hypertension |
| 124802172 | 12480217 | 7 | Chronic obstructive pulmonary disease |
| 124802172 | 12480217 | 8 | Chronic obstructive pulmonary disease |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124802172 | 12480217 | OT |
| 124802172 | 12480217 | HO |
| 124802172 | 12480217 | DS |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124802172 | 12480217 | Bradycardia | |
| 124802172 | 12480217 | Cardiac failure | |
| 124802172 | 12480217 | Crohn's disease | |
| 124802172 | 12480217 | Fatigue | |
| 124802172 | 12480217 | Pneumonia | |
| 124802172 | 12480217 | Pseudomonas infection | |
| 124802172 | 12480217 | Weight decreased |
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 |
|---|---|---|---|---|---|---|
| 124802172 | 12480217 | 1 | 201602 | 20160423 | 0 |