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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126300945 | 12630094 | 5 | F | 2016 | 20160927 | 20160808 | 20160929 | EXP | US-JNJFOC-20160723318 | JANSSEN | 76.15 | YR | E | F | Y | 76.66000 | KG | 20160929 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126300945 | 12630094 | 1 | SS | SIMPONI ARIA | GOLIMUMAB | 1 | Intravenous (not otherwise specified) | Y | U | UNKNOWN;UNKNOWN | 0 | INJECTION | |||||||
| 126300945 | 12630094 | 2 | SS | SIMPONI ARIA | GOLIMUMAB | 1 | Intravenous (not otherwise specified) | Y | U | UNKNOWN;UNKNOWN | 0 | 150 | MG | INJECTION | |||||
| 126300945 | 12630094 | 3 | SS | SIMPONI ARIA | GOLIMUMAB | 1 | Intravenous (not otherwise specified) | Y | U | UNKNOWN;UNKNOWN | 0 | INJECTION | |||||||
| 126300945 | 12630094 | 4 | SS | SIMPONI ARIA | GOLIMUMAB | 1 | Intravenous (not otherwise specified) | Y | U | UNKNOWN;UNKNOWN | 0 | 150 | MG | INJECTION | |||||
| 126300945 | 12630094 | 5 | SS | SIMPONI ARIA | GOLIMUMAB | 1 | Intravenous (not otherwise specified) | Y | U | UNKNOWN;UNKNOWN | 0 | INJECTION | |||||||
| 126300945 | 12630094 | 6 | PS | SIMPONI ARIA | GOLIMUMAB | 1 | Intravenous (not otherwise specified) | Y | U | UNKNOWN;UNKNOWN | 125433 | INJECTION | |||||||
| 126300945 | 12630094 | 7 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | 1 A.M | D | 0 | 10 | MG | TABLET | QD | |||||
| 126300945 | 12630094 | 8 | C | BUPROPION HCL | BUPROPION HYDROCHLORIDE | 1 | Unknown | 1 A.M | D | 0 | 100 | MG | TABLET | QD | |||||
| 126300945 | 12630094 | 9 | C | BUPROPION HCL | BUPROPION HYDROCHLORIDE | 1 | Unknown | 1 A.M | D | 0 | 100 | MG | TABLET | QD | |||||
| 126300945 | 12630094 | 10 | C | FENTANYL. | FENTANYL | 1 | Unknown | D | 0 | 25 | UG | PATCH | |||||||
| 126300945 | 12630094 | 11 | C | IBANDRONATE SODIUM. | IBANDRONATE SODIUM | 1 | Unknown | D | 0 | 150 | MG | TABLET | /wk | ||||||
| 126300945 | 12630094 | 12 | C | METHOTREXATE. | METHOTREXATE | 1 | Unknown | 5 TABLETS A.M AND 5 TABLETS P.M WEEKLY | D | 0 | 2.5 | MG | TABLET | ||||||
| 126300945 | 12630094 | 13 | C | NEXIUM | ESOMEPRAZOLE MAGNESIUM | 1 | Unknown | 1 A.M | D | 0 | 40 | MG | UNSPECIFIED | QD | |||||
| 126300945 | 12630094 | 14 | C | SIMVASTATIN. | SIMVASTATIN | 1 | Unknown | D | 0 | 20 | MG | UNSPECIFIED | QD | ||||||
| 126300945 | 12630094 | 15 | C | LOSARTAN. | LOSARTAN | 1 | Unknown | 1 A.M | D | 0 | 50 | MG | UNSPECIFIED | QD | |||||
| 126300945 | 12630094 | 16 | C | HYDROMORPHONE | HYDROMORPHONE | 1 | Unknown | WHEN NEEDED (PRN) | D | 0 | 2 | MG | TABLET | TID | |||||
| 126300945 | 12630094 | 17 | C | AMLODIPINE | AMLODIPINE BESYLATE | 1 | Unknown | 1/2 A.M | D | 0 | 10 | MG | UNSPECIFIED | QD | |||||
| 126300945 | 12630094 | 18 | C | BACTROBAN | MUPIROCINMUPIROCIN CALCIUM | 1 | Unknown | D | 0 | UNSPECIFIED | |||||||||
| 126300945 | 12630094 | 19 | C | ECONAZOLE | ECONAZOLE | 1 | Unknown | D | 0 | 1 | PCT | UNSPECIFIED | |||||||
| 126300945 | 12630094 | 20 | C | TRIAMCINOLONE | TRIAMCINOLONE | 1 | Unknown | D | 0 | UNSPECIFIED | |||||||||
| 126300945 | 12630094 | 21 | C | FISH OIL | FISH OIL | 1 | Unknown | 1 A.M - 1 P.M | D | 0 | 1000 | MG | UNSPECIFIED | TID | |||||
| 126300945 | 12630094 | 22 | C | CALCIUM | CALCIUM | 1 | Unknown | 1 A.M - 1 P.M | D | 0 | 600 | MG | UNSPECIFIED | BID | |||||
| 126300945 | 12630094 | 23 | C | IBUPROFEN. | IBUPROFEN | 1 | Unknown | 2 TO 3 IN AM?? 2 A.M - 2 P.M | D | 0 | 200 | MG | UNSPECIFIED | ||||||
| 126300945 | 12630094 | 24 | C | CRANBERRY. | CRANBERRY | 1 | Unknown | 2 P.M | D | 0 | 84 | MG | TABLET | QD | |||||
| 126300945 | 12630094 | 25 | C | OCUVITE | VITAMINS | 1 | Unknown | D | 0 | UNSPECIFIED | |||||||||
| 126300945 | 12630094 | 26 | C | ATORVASTATIN | ATORVASTATIN | 1 | Unknown | 1 P.M | D | 0 | 40 | MG | UNSPECIFIED | ||||||
| 126300945 | 12630094 | 27 | C | FOLIC ACID. | FOLIC ACID | 1 | Unknown | 1 A.M | D | 0 | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126300945 | 12630094 | 1 | Rheumatoid arthritis |
| 126300945 | 12630094 | 2 | Rheumatoid arthritis |
| 126300945 | 12630094 | 3 | Rheumatoid arthritis |
| 126300945 | 12630094 | 4 | Palindromic rheumatism |
| 126300945 | 12630094 | 5 | Palindromic rheumatism |
| 126300945 | 12630094 | 6 | Palindromic rheumatism |
| 126300945 | 12630094 | 7 | Product used for unknown indication |
| 126300945 | 12630094 | 8 | Pain |
| 126300945 | 12630094 | 9 | Depression |
| 126300945 | 12630094 | 10 | Pain |
| 126300945 | 12630094 | 11 | Bone development abnormal |
| 126300945 | 12630094 | 12 | Arthritis |
| 126300945 | 12630094 | 14 | Blood cholesterol |
| 126300945 | 12630094 | 19 | Fungal skin infection |
| 126300945 | 12630094 | 25 | Vitamin supplementation |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126300945 | 12630094 | HO |
| 126300945 | 12630094 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126300945 | 12630094 | Fatigue | |
| 126300945 | 12630094 | Influenza like illness | |
| 126300945 | 12630094 | Macular degeneration | |
| 126300945 | 12630094 | Nausea | |
| 126300945 | 12630094 | Off label use | |
| 126300945 | 12630094 | Palindromic rheumatism | |
| 126300945 | 12630094 | Product use issue | |
| 126300945 | 12630094 | Rheumatoid arthritis | |
| 126300945 | 12630094 | Skin exfoliation | |
| 126300945 | 12630094 | Urinary tract infection | |
| 126300945 | 12630094 | Weight increased |
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 |
|---|---|---|---|---|---|---|
| 126300945 | 12630094 | 1 | 20160526 | 0 | ||
| 126300945 | 12630094 | 2 | 20160425 | 0 | ||
| 126300945 | 12630094 | 3 | 20160718 | 0 | ||
| 126300945 | 12630094 | 4 | 20160425 | 0 | ||
| 126300945 | 12630094 | 5 | 20160526 | 0 | ||
| 126300945 | 12630094 | 6 | 20160718 | 0 | ||
| 126300945 | 12630094 | 10 | 2013 | 0 |