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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 98125195 | 9812519 | 5 | F | 2011 | 20160704 | 20140113 | 20160712 | EXP | BR-JNJFOC-20140103718 | JANSSEN | 0.00 | A | M | Y | 87.00000 | KG | 20160712 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 98125195 | 9812519 | 1 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | U | UNKNOWN;UNKNOWN | 0 | LYOPHILIZED POWDER | |||||||
| 98125195 | 9812519 | 2 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | U | UNKNOWN;UNKNOWN | 0 | LYOPHILIZED POWDER | |||||||
| 98125195 | 9812519 | 3 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | U | UNKNOWN;UNKNOWN | 0 | LYOPHILIZED POWDER | |||||||
| 98125195 | 9812519 | 4 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | U | UNKNOWN;UNKNOWN | 0 | LYOPHILIZED POWDER | |||||||
| 98125195 | 9812519 | 5 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | 4 VIALS PER INFUSION | Y | U | UNKNOWN;UNKNOWN | 0 | LYOPHILIZED POWDER | ||||||
| 98125195 | 9812519 | 6 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | U | UNKNOWN;UNKNOWN | 0 | 400 | MG | LYOPHILIZED POWDER | |||||
| 98125195 | 9812519 | 7 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | U | UNKNOWN;UNKNOWN | 0 | 400 | MG | LYOPHILIZED POWDER | |||||
| 98125195 | 9812519 | 8 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | U | UNKNOWN;UNKNOWN | 0 | 400 | MG | LYOPHILIZED POWDER | |||||
| 98125195 | 9812519 | 9 | PS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | U | UNKNOWN;UNKNOWN | 103772 | LYOPHILIZED POWDER | |||||||
| 98125195 | 9812519 | 10 | C | SULFASALAZINE. | SULFASALAZINE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 98125195 | 9812519 | 11 | C | ACETAMINOPHEN. | ACETAMINOPHEN | 1 | Unknown | 0 | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 98125195 | 9812519 | 1 | Ankylosing spondylitis |
| 98125195 | 9812519 | 2 | Ankylosing spondylitis |
| 98125195 | 9812519 | 3 | Ankylosing spondylitis |
| 98125195 | 9812519 | 4 | Ankylosing spondylitis |
| 98125195 | 9812519 | 5 | Ankylosing spondylitis |
| 98125195 | 9812519 | 6 | Ankylosing spondylitis |
| 98125195 | 9812519 | 7 | Ankylosing spondylitis |
| 98125195 | 9812519 | 8 | Ankylosing spondylitis |
| 98125195 | 9812519 | 9 | Ankylosing spondylitis |
| 98125195 | 9812519 | 10 | Ankylosing spondylitis |
| 98125195 | 9812519 | 11 | Pain |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 98125195 | 9812519 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 98125195 | 9812519 | Ankylosing spondylitis | |
| 98125195 | 9812519 | Arthralgia | |
| 98125195 | 9812519 | Arthritis | |
| 98125195 | 9812519 | Cyst | |
| 98125195 | 9812519 | Diabetes mellitus | |
| 98125195 | 9812519 | Drug ineffective | |
| 98125195 | 9812519 | Haemorrhage | |
| 98125195 | 9812519 | Hypersensitivity | |
| 98125195 | 9812519 | Incorrect drug administration rate | |
| 98125195 | 9812519 | Incorrect product storage | |
| 98125195 | 9812519 | Intestinal haemorrhage | |
| 98125195 | 9812519 | Joint effusion | |
| 98125195 | 9812519 | Lymphadenopathy | |
| 98125195 | 9812519 | Medication error | |
| 98125195 | 9812519 | Off label use | |
| 98125195 | 9812519 | Pain | |
| 98125195 | 9812519 | Product use issue | |
| 98125195 | 9812519 | Pruritus generalised | |
| 98125195 | 9812519 | Psoriasis | |
| 98125195 | 9812519 | Skin disorder | |
| 98125195 | 9812519 | Urticaria | |
| 98125195 | 9812519 | Varicella |
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 |
|---|---|---|---|---|---|---|
| 98125195 | 9812519 | 1 | 20160223 | 0 | ||
| 98125195 | 9812519 | 2 | 201409 | 0 | ||
| 98125195 | 9812519 | 3 | 20150826 | 201510 | 0 | |
| 98125195 | 9812519 | 4 | 201512 | 0 | ||
| 98125195 | 9812519 | 5 | 201401 | 0 | ||
| 98125195 | 9812519 | 6 | 2007 | 2011 | 0 | |
| 98125195 | 9812519 | 7 | 2011 | 2012 | 0 | |
| 98125195 | 9812519 | 8 | 2008 | 2013 | 0 | |
| 98125195 | 9812519 | 9 | 2006 | 0 |