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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122977393 | 12297739 | 3 | F | 201307 | 20160630 | 20160422 | 20160707 | EXP | US-ABBVIE-16K-163-1610326-00 | ABBVIE | 55.22 | YR | M | Y | 92.62000 | KG | 20160707 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122977393 | 12297739 | 1 | PS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | LOADING DOSE | 1053312 | 125057 | 160 | MG | SOLUTION FOR INJECTION IN PRE-FILLED PEN | ||||||
| 122977393 | 12297739 | 2 | SS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | TWO WEEKS AFTER 160 MG DOSE | 1053312 | 125057 | 80 | MG | SOLUTION FOR INJECTION IN PRE-FILLED PEN | ||||||
| 122977393 | 12297739 | 3 | SS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | FOUR WEEKS AFTER 160 MG DOSE | 1053312 | 125057 | 40 | MG | SOLUTION FOR INJECTION IN PRE-FILLED PEN | QOW | |||||
| 122977393 | 12297739 | 4 | SS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | FOUR WEEKS AFTER 160 MG DOSE | 1053312 | 125057 | 40 | MG | SOLUTION FOR INJECTION IN PRE-FILLED PEN | QOW | |||||
| 122977393 | 12297739 | 5 | SS | SYNTHROID | LEVOTHYROXINE SODIUM | 1 | Oral | Y | UNKNOWN | 21402 | 125 | UG | TABLET | QD | |||||
| 122977393 | 12297739 | 6 | SS | SYNTHROID | LEVOTHYROXINE SODIUM | 1 | Oral | TOOK ONE HALF TAB | Y | UNKNOWN | 21402 | 62.5 | UG | TABLET | QD | ||||
| 122977393 | 12297739 | 7 | SS | CRESTOR | ROSUVASTATIN CALCIUM | 1 | Oral | 0 | |||||||||||
| 122977393 | 12297739 | 8 | C | ATENOLOL. | ATENOLOL | 1 | 0 | ||||||||||||
| 122977393 | 12297739 | 9 | C | AMLODIPINE | AMLODIPINE BESYLATE | 1 | 0 | ||||||||||||
| 122977393 | 12297739 | 10 | C | IMURAN | AZATHIOPRINE | 1 | 0 | ||||||||||||
| 122977393 | 12297739 | 11 | C | ZOFRAN | ONDANSETRON HYDROCHLORIDE | 1 | 0 | ||||||||||||
| 122977393 | 12297739 | 12 | C | TEMAZEPAM. | TEMAZEPAM | 1 | 0 | ||||||||||||
| 122977393 | 12297739 | 13 | C | TRAMADOL. | TRAMADOL | 1 | 0 | ||||||||||||
| 122977393 | 12297739 | 14 | C | HYOSCYAMINE. | HYOSCYAMINE | 1 | 0 | ||||||||||||
| 122977393 | 12297739 | 15 | C | DICYCLOMINE | DICYCLOMINE HYDROCHLORIDE | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 122977393 | 12297739 | 1 | Crohn's disease |
| 122977393 | 12297739 | 5 | Hypothyroidism |
| 122977393 | 12297739 | 7 | Blood cholesterol increased |
| 122977393 | 12297739 | 8 | Hypertension |
| 122977393 | 12297739 | 9 | Hypertension |
| 122977393 | 12297739 | 10 | Crohn's disease |
| 122977393 | 12297739 | 11 | Nausea |
| 122977393 | 12297739 | 12 | Insomnia |
| 122977393 | 12297739 | 13 | Product used for unknown indication |
| 122977393 | 12297739 | 14 | Abdominal pain |
| 122977393 | 12297739 | 15 | Abdominal pain |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 122977393 | 12297739 | HO |
| 122977393 | 12297739 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 122977393 | 12297739 | Abdominal pain | |
| 122977393 | 12297739 | Blood thyroid stimulating hormone increased | |
| 122977393 | 12297739 | Dysuria | |
| 122977393 | 12297739 | Faecaloma | |
| 122977393 | 12297739 | Feeling abnormal | |
| 122977393 | 12297739 | Hernia | |
| 122977393 | 12297739 | Incorrect dose administered | |
| 122977393 | 12297739 | Intestinal stenosis | |
| 122977393 | 12297739 | Pain in extremity | |
| 122977393 | 12297739 | Postoperative adhesion | |
| 122977393 | 12297739 | Rectal discharge |
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 |
|---|---|---|---|---|---|---|
| 122977393 | 12297739 | 1 | 20130411 | 20130411 | 0 | |
| 122977393 | 12297739 | 2 | 2013 | 2013 | 0 | |
| 122977393 | 12297739 | 3 | 2013 | 201307 | 0 | |
| 122977393 | 12297739 | 4 | 2013 | 0 | ||
| 122977393 | 12297739 | 5 | 201604 | 0 | ||
| 122977393 | 12297739 | 6 | 201604 | 0 | ||
| 122977393 | 12297739 | 7 | 201412 | 0 |