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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 98744605 | 9874460 | 5 | F | 201312 | 20140917 | 20140206 | 20141001 | EXP | US-BIOGENIDEC-2014BI011478 | BIOGEN | 36.00 | YR | F | Y | 39.00000 | KG | 20141001 | N | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 98744605 | 9874460 | 1 | PS | TYSABRI | NATALIZUMAB | 1 | INTRAVENOUS | D | 125104 | 300 | MG | INTRAVENOUS INFUSION | /month | ||||||
| 98744605 | 9874460 | 2 | SS | TYSABRI | NATALIZUMAB | 1 | INTRAVENOUS | D | 125104 | 300 | MG | INTRAVENOUS INFUSION | /month | ||||||
| 98744605 | 9874460 | 3 | SS | TYSABRI | NATALIZUMAB | 1 | INTRAVENOUS | D | 125104 | 300 | MG | INTRAVENOUS INFUSION | /month | ||||||
| 98744605 | 9874460 | 4 | C | REMICADE | INFLIXIMAB | 1 | D | 0 | |||||||||||
| 98744605 | 9874460 | 5 | C | HUMIRA | ADALIMUMAB | 1 | D | 0 | |||||||||||
| 98744605 | 9874460 | 6 | C | CIMZIA | CERTOLIZUMAB PEGOL | 1 | D | 0 | |||||||||||
| 98744605 | 9874460 | 7 | C | METHOTREXATE | METHOTREXATE | 1 | D | 0 | |||||||||||
| 98744605 | 9874460 | 8 | C | METHOTREXATE | METHOTREXATE | 1 | SUBCUTANEOUS | D | 0 | 25 | MG | /wk | |||||||
| 98744605 | 9874460 | 9 | C | VEDOLIZUMAB | VEDOLIZUMAB | 1 | INTRAVENOUS | D | 0 | ||||||||||
| 98744605 | 9874460 | 10 | C | NEXIUM | ESOMEPRAZOLE MAGNESIUM | 1 | ORAL | D | 0 | 40 | MG | CAPSULE | QD | ||||||
| 98744605 | 9874460 | 11 | C | NEXIUM | ESOMEPRAZOLE MAGNESIUM | 1 | D | 0 | 40 | MG | CAPSULE | BID | |||||||
| 98744605 | 9874460 | 12 | C | FOLIC ACID. | FOLIC ACID | 1 | ORAL | D | 0 | 1 | MG | TABLET | QD | ||||||
| 98744605 | 9874460 | 13 | C | PREDNISONE. | PREDNISONE | 1 | D | 0 | |||||||||||
| 98744605 | 9874460 | 14 | C | ALPRAZOLAM. | ALPRAZOLAM | 1 | ORAL | D | 0 | 1 | MG | TABLET | QD | ||||||
| 98744605 | 9874460 | 15 | C | CLINDAMYCIN | CLINDAMYCINCLINDAMYCIN PHOSPHATE | 1 | ORAL | D | 0 | 300 | MG | CAPSULE | BID | ||||||
| 98744605 | 9874460 | 16 | C | CYPROHEPTADINE. | CYPROHEPTADINE | 1 | ORAL | D | 0 | 4 | MG | TABLET | TID | ||||||
| 98744605 | 9874460 | 17 | C | DEXTROSE. | DEXTROSE | 1 | INTRAVENOUS | D | 0 | 50 | PCT | ||||||||
| 98744605 | 9874460 | 18 | C | DICYCLOMINE | DICYCLOMINE HYDROCHLORIDE | 1 | ORAL | D | 0 | 10 | MG | CAPSULE | |||||||
| 98744605 | 9874460 | 19 | C | ALORA | ESTRADIOL | 1 | TRANSDERMAL | D | 0 | 0 | MG | ||||||||
| 98744605 | 9874460 | 20 | C | ESTRACE | ESTRADIOL | 1 | ORAL | D | 0 | 2 | MG | TABLET | QD | ||||||
| 98744605 | 9874460 | 21 | C | FENTANYL. | FENTANYL | 1 | TRANSDERMAL | D | 0 | 50 | UG | TRANSDERMAL PATCH | |||||||
| 98744605 | 9874460 | 22 | C | GABAPENTIN. | GABAPENTIN | 1 | ORAL | D | 0 | 600 | MG | TABLET | TID | ||||||
| 98744605 | 9874460 | 23 | C | LEVOTHYROXINE | LEVOTHYROXINE | 1 | INTRAVENOUS | D | 0 | 100 | UG | QD | |||||||
| 98744605 | 9874460 | 24 | C | LEVOTHYROXINE | LEVOTHYROXINE | 1 | ORAL | D | 0 | 75 | UG | TABLET | QD | ||||||
| 98744605 | 9874460 | 25 | C | MUPIROCIN. | MUPIROCIN | 1 | D | 0 | 2 | PCT | OINTMENT | ||||||||
| 98744605 | 9874460 | 26 | C | PERCOCET | ACETAMINOPHENOXYCODONE HYDROCHLORIDE | 1 | ORAL | D | 0 | 10 | MG | TABLET | |||||||
| 98744605 | 9874460 | 27 | C | TRIAMCINOLONE | TRIAMCINOLONE | 1 | D | 0 | 0 | PCT | OINTMENT | BID | |||||||
| 98744605 | 9874460 | 28 | C | TRAZODONE | TRAZODONE HYDROCHLORIDE | 1 | ORAL | D | 0 | 100 | MG | TABLET | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 98744605 | 9874460 | 1 | Crohn's disease |
| 98744605 | 9874460 | 2 | Crohn's disease |
| 98744605 | 9874460 | 3 | Crohn's disease |
| 98744605 | 9874460 | 26 | Pain |
| 98744605 | 9874460 | 27 | Rash |
| 98744605 | 9874460 | 28 | Insomnia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 98744605 | 9874460 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 98744605 | 9874460 | Abdominal pain | |
| 98744605 | 9874460 | Acute respiratory distress syndrome | |
| 98744605 | 9874460 | Crohn's disease | |
| 98744605 | 9874460 | Dyspnoea | |
| 98744605 | 9874460 | Gastrointestinal disorder | |
| 98744605 | 9874460 | Gastrointestinal disorder postoperative | |
| 98744605 | 9874460 | Hysterectomy | |
| 98744605 | 9874460 | Intestinal perforation | |
| 98744605 | 9874460 | Pyrexia | |
| 98744605 | 9874460 | Sepsis | |
| 98744605 | 9874460 | Volvulus |
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 |
|---|---|---|---|---|---|---|
| 98744605 | 9874460 | 1 | 20121206 | 201306 | 0 | |
| 98744605 | 9874460 | 2 | 20131204 | 20131204 | 0 | |
| 98744605 | 9874460 | 3 | 2014 | 0 | ||
| 98744605 | 9874460 | 7 | 201301 | 201306 | 0 | |
| 98744605 | 9874460 | 8 | 20140714 | 20140813 | 0 | |
| 98744605 | 9874460 | 11 | 20140714 | 0 | ||
| 98744605 | 9874460 | 12 | 20140714 | 0 |