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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126684001 | 12668400 | 1 | I | 2015 | 20160610 | 20160819 | 20160819 | EXP | US-ABBVIE-16K-163-1651352-00 | ABBVIE | 0.00 | F | Y | 72.64000 | KG | 20160819 | CN | COUNTRY NOT SPECIFIED | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126684001 | 12668400 | 1 | PS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | LOADING DOSE | UNKNOWN | 125057 | 160 | MG | SOLUTION FOR INJECTION IN PRE-FILLED PEN | ||||||
| 126684001 | 12668400 | 2 | SS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | LOADING DOSE, TWO WEEKS AFTER 160MG DOSE | UNKNOWN | 125057 | 80 | MG | SOLUTION FOR INJECTION IN PRE-FILLED PEN | ||||||
| 126684001 | 12668400 | 3 | SS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | TWO WEEKS AFTER 80MG DOSE | UNKNOWN | 125057 | 40 | MG | SOLUTION FOR INJECTION IN PRE-FILLED PEN | QOW | |||||
| 126684001 | 12668400 | 4 | SS | ALBUTEROL. | ALBUTEROL | 1 | Unknown | UNKNOWN | 0 | ||||||||||
| 126684001 | 12668400 | 5 | C | PENTASA | MESALAMINE | 1 | 0 | ||||||||||||
| 126684001 | 12668400 | 6 | C | PRENATAL VITAMINS | VITAMINS | 1 | 0 | ||||||||||||
| 126684001 | 12668400 | 7 | C | BIOTIN | BIOTIN | 1 | 0 | ||||||||||||
| 126684001 | 12668400 | 8 | C | CLARITIN | LORATADINE | 1 | 0 | ||||||||||||
| 126684001 | 12668400 | 9 | C | BENADRYL | DIPHENHYDRAMINE HYDROCHLORIDE | 1 | 0 | ||||||||||||
| 126684001 | 12668400 | 10 | C | XANAX | ALPRAZOLAM | 1 | 0 | ||||||||||||
| 126684001 | 12668400 | 11 | C | MELATONIN | MELATONIN | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126684001 | 12668400 | 1 | Crohn's disease |
| 126684001 | 12668400 | 4 | Asthma |
| 126684001 | 12668400 | 5 | Crohn's disease |
| 126684001 | 12668400 | 6 | Product used for unknown indication |
| 126684001 | 12668400 | 7 | Product used for unknown indication |
| 126684001 | 12668400 | 8 | Hypersensitivity |
| 126684001 | 12668400 | 9 | Hypersensitivity |
| 126684001 | 12668400 | 10 | Anxiety |
| 126684001 | 12668400 | 11 | Sleep disorder therapy |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126684001 | 12668400 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126684001 | 12668400 | Abortion spontaneous | |
| 126684001 | 12668400 | Bronchitis | |
| 126684001 | 12668400 | Candida infection | |
| 126684001 | 12668400 | Exposure during pregnancy | |
| 126684001 | 12668400 | Hot flush | |
| 126684001 | 12668400 | Nausea | |
| 126684001 | 12668400 | Pyrexia | |
| 126684001 | 12668400 | Vomiting in pregnancy |
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 |
|---|---|---|---|---|---|---|
| 126684001 | 12668400 | 1 | 20150916 | 20150916 | 0 | |
| 126684001 | 12668400 | 2 | 2015 | 2015 | 0 | |
| 126684001 | 12668400 | 3 | 2015 | 0 |