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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125494994 | 12549499 | 4 | F | 201212 | 20160915 | 20160712 | 20160919 | EXP | PT-ABBVIE-16K-130-1671886-00 | ABBVIE | 61.00 | YR | F | Y | 53.00000 | KG | 20160919 | CN | COUNTRY NOT SPECIFIED | PT |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125494994 | 12549499 | 1 | PS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | D | N | UNKNOWN | 125057 | 40 | MG | SOLUTION FOR INJECTION IN PRE-FILLED PEN | /wk | ||||
| 125494994 | 12549499 | 2 | SS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | LOADING DOSE ONE(WEEK ZERO) | D | UNKNOWN | 125057 | 160 | MG | SOLUTION FOR INJECTION | |||||
| 125494994 | 12549499 | 3 | SS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | WEEK TWO, LOADING DOSE 2 | D | UNKNOWN | 125057 | 80 | MG | SOLUTION FOR INJECTION | |||||
| 125494994 | 12549499 | 4 | SS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | WEEK FOUR, MAINTENANCE DOSE | D | UNKNOWN | 125057 | 40 | MG | SOLUTION FOR INJECTION | /wk | ||||
| 125494994 | 12549499 | 5 | SS | TRASTUZUMAB | TRASTUZUMAB | 1 | Unknown | 4 ADMINISTRATIONS | D | UNKNOWN | 0 | ||||||||
| 125494994 | 12549499 | 6 | C | VENLAFAXINE | VENLAFAXINE HYDROCHLORIDE | 1 | Oral | 0 | TABLET | ||||||||||
| 125494994 | 12549499 | 7 | C | ADT | AMITRIPTYLINE HYDROCHLORIDE | 1 | Oral | 0 | TABLET | ||||||||||
| 125494994 | 12549499 | 8 | C | VIGANTOL | 2 | Oral | 0 | ORAL DROPS | |||||||||||
| 125494994 | 12549499 | 9 | C | VIGANTOL | 2 | Oral | 0 | ORAL DROPS |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125494994 | 12549499 | 1 | Crohn's disease |
| 125494994 | 12549499 | 2 | Crohn's disease |
| 125494994 | 12549499 | 5 | Breast cancer |
| 125494994 | 12549499 | 6 | Anxiety |
| 125494994 | 12549499 | 7 | Anxiety |
| 125494994 | 12549499 | 8 | Anxiety |
| 125494994 | 12549499 | 9 | Anxiety |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125494994 | 12549499 | HO |
| 125494994 | 12549499 | LT |
| 125494994 | 12549499 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125494994 | 12549499 | Anxiety | |
| 125494994 | 12549499 | Breast cancer female | |
| 125494994 | 12549499 | Crohn's disease | |
| 125494994 | 12549499 | Dizziness | |
| 125494994 | 12549499 | Frequent bowel movements | |
| 125494994 | 12549499 | Post procedural fistula | |
| 125494994 | 12549499 | Vomiting | |
| 125494994 | 12549499 | Wound complication |
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 |
|---|---|---|---|---|---|---|
| 125494994 | 12549499 | 1 | 2010 | 201212 | 0 | |
| 125494994 | 12549499 | 2 | 20160615 | 20160615 | 0 | |
| 125494994 | 12549499 | 3 | 20160629 | 20160629 | 0 | |
| 125494994 | 12549499 | 4 | 20160713 | 0 | ||
| 125494994 | 12549499 | 5 | 201405 | 0 | ||
| 125494994 | 12549499 | 7 | 2015 | 0 | ||
| 125494994 | 12549499 | 8 | 2015 | 0 | ||
| 125494994 | 12549499 | 9 | 2015 | 0 |