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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 120051209 | 12005120 | 9 | F | 2016 | 20160913 | 20160204 | 20160919 | EXP | CA-JNJFOC-20160121098 | JANSSEN | 40.82 | YR | A | F | Y | 54.00000 | KG | 20160919 | OT | CA | CA |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 120051209 | 12005120 | 1 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | N | FGM59011;FIM79013;FIM76014 +MORE | 0 | 300 | MG | LYOPHILIZED POWDER | |||||
| 120051209 | 12005120 | 2 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | N | FGM59011;FIM79013;FIM76014 +MORE | 0 | 300 | MG | LYOPHILIZED POWDER | |||||
| 120051209 | 12005120 | 3 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | N | FGM59011;FIM79013;FIM76014 +MORE | 0 | 300 | MG | LYOPHILIZED POWDER | |||||
| 120051209 | 12005120 | 4 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | N | FGM59011;FIM79013;FIM76014 +MORE | 0 | 300 | MG | LYOPHILIZED POWDER | |||||
| 120051209 | 12005120 | 5 | PS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | N | FGM59011;FIM79013;FIM76014 +MORE | 103772 | 300 | MG | LYOPHILIZED POWDER | |||||
| 120051209 | 12005120 | 6 | C | SYMBICORT | BUDESONIDEFORMOTEROL FUMARATE DIHYDRATE | 1 | Unknown | D | 0 | 2 | DF | UNSPECIFIED | |||||||
| 120051209 | 12005120 | 7 | C | PENTASA | MESALAMINE | 1 | Unknown | D | 0 | 4 | DF | UNSPECIFIED | BID | ||||||
| 120051209 | 12005120 | 8 | C | ZOFRAN | ONDANSETRON HYDROCHLORIDE | 1 | Unknown | D | 0 | PATCH | |||||||||
| 120051209 | 12005120 | 9 | C | PERCOCET | ACETAMINOPHENOXYCODONE HYDROCHLORIDE | 1 | Unknown | D | 0 | UNSPECIFIED | |||||||||
| 120051209 | 12005120 | 10 | C | VENTOLIN | ALBUTEROL SULFATE | 1 | Unknown | D | 0 | 2 | DF | UNSPECIFIED | |||||||
| 120051209 | 12005120 | 11 | C | PARACETAMOL | ACETAMINOPHEN | 1 | Oral | D | 0 | 600 | MG | UNSPECIFIED | |||||||
| 120051209 | 12005120 | 12 | C | PARACETAMOL | ACETAMINOPHEN | 1 | Oral | D | 0 | 600 | MG | UNSPECIFIED | |||||||
| 120051209 | 12005120 | 13 | C | PARACETAMOL | ACETAMINOPHEN | 1 | Oral | D | 0 | 600 | MG | UNSPECIFIED | |||||||
| 120051209 | 12005120 | 14 | C | DIPHENHYDRAMINE. | DIPHENHYDRAMINE | 1 | Intravenous (not otherwise specified) | D | 0 | 50 | MG | UNSPECIFIED | |||||||
| 120051209 | 12005120 | 15 | C | DIPHENHYDRAMINE. | DIPHENHYDRAMINE | 1 | Intravenous (not otherwise specified) | D | 0 | 50 | MG | UNSPECIFIED | |||||||
| 120051209 | 12005120 | 16 | C | HYDROCORTISONE. | HYDROCORTISONE | 1 | Intravenous (not otherwise specified) | D | 0 | 200 | MG | UNSPECIFIED | |||||||
| 120051209 | 12005120 | 17 | C | HYDROCORTISONE. | HYDROCORTISONE | 1 | Intravenous (not otherwise specified) | D | 0 | 200 | MG | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 120051209 | 12005120 | 1 | Crohn's disease |
| 120051209 | 12005120 | 2 | Crohn's disease |
| 120051209 | 12005120 | 3 | Crohn's disease |
| 120051209 | 12005120 | 4 | Crohn's disease |
| 120051209 | 12005120 | 5 | Crohn's disease |
| 120051209 | 12005120 | 11 | Premedication |
| 120051209 | 12005120 | 12 | Premedication |
| 120051209 | 12005120 | 13 | Premedication |
| 120051209 | 12005120 | 14 | Premedication |
| 120051209 | 12005120 | 15 | Premedication |
| 120051209 | 12005120 | 16 | Premedication |
| 120051209 | 12005120 | 17 | Premedication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 120051209 | 12005120 | HO |
| 120051209 | 12005120 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 120051209 | 12005120 | Crohn's disease | |
| 120051209 | 12005120 | Fungal infection | |
| 120051209 | 12005120 | General physical health deterioration | |
| 120051209 | 12005120 | Haematemesis | |
| 120051209 | 12005120 | Infrequent bowel movements | |
| 120051209 | 12005120 | Infusion related reaction | |
| 120051209 | 12005120 | Pneumonia | |
| 120051209 | 12005120 | Pruritus | |
| 120051209 | 12005120 | Vomiting |
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 |
|---|---|---|---|---|---|---|
| 120051209 | 12005120 | 1 | 20160112 | 0 | ||
| 120051209 | 12005120 | 2 | 20160126 | 0 | ||
| 120051209 | 12005120 | 3 | 20160226 | 0 | ||
| 120051209 | 12005120 | 4 | 20160421 | 0 | ||
| 120051209 | 12005120 | 5 | 20160616 | 0 | ||
| 120051209 | 12005120 | 11 | 20160126 | 0 | ||
| 120051209 | 12005120 | 12 | 20160226 | 0 | ||
| 120051209 | 12005120 | 13 | 20160421 | 0 | ||
| 120051209 | 12005120 | 14 | 20160226 | 0 | ||
| 120051209 | 12005120 | 15 | 20160422 | 0 | ||
| 120051209 | 12005120 | 16 | 20160226 | 0 | ||
| 120051209 | 12005120 | 17 | 20160422 | 0 |