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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125634461 | 12563446 | 1 | I | 2016 | 20160708 | 20160715 | 20160715 | EXP | US-ABBVIE-16K-163-1672168-00 | ABBVIE | 62.59 | YR | M | Y | 0.00000 | 20160715 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125634461 | 12563446 | 1 | PS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | UNKNOWN | 125057 | SOLUTION FOR INJECTION IN PRE-FILLED PEN | |||||||||
| 125634461 | 12563446 | 2 | SS | OMEPRAZOLE. | OMEPRAZOLE | 1 | Oral | N | UNKNOWN | 0 | |||||||||
| 125634461 | 12563446 | 3 | C | OLANZAPINE. | OLANZAPINE | 1 | 0 | ||||||||||||
| 125634461 | 12563446 | 4 | C | SUBOXONE | BUPRENORPHINE HYDROCHLORIDENALOXONE HYDROCHLORIDE | 1 | 0 | ||||||||||||
| 125634461 | 12563446 | 5 | C | GRALISE | GABAPENTIN | 1 | 0 | ||||||||||||
| 125634461 | 12563446 | 6 | C | AMBIEN | ZOLPIDEM TARTRATE | 1 | 0 | ||||||||||||
| 125634461 | 12563446 | 7 | C | TESTOSTERONE. | TESTOSTERONE | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125634461 | 12563446 | 1 | Colitis |
| 125634461 | 12563446 | 2 | Product used for unknown indication |
| 125634461 | 12563446 | 3 | Product used for unknown indication |
| 125634461 | 12563446 | 4 | Product used for unknown indication |
| 125634461 | 12563446 | 5 | Product used for unknown indication |
| 125634461 | 12563446 | 6 | Product used for unknown indication |
| 125634461 | 12563446 | 7 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125634461 | 12563446 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125634461 | 12563446 | Body temperature decreased | |
| 125634461 | 12563446 | Chills | |
| 125634461 | 12563446 | Hyperhidrosis | |
| 125634461 | 12563446 | Impaired gastric emptying | |
| 125634461 | 12563446 | Intestinal metaplasia | |
| 125634461 | 12563446 | Nausea | |
| 125634461 | 12563446 | Precancerous cells present |
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 |
|---|---|---|---|---|---|---|
| 125634461 | 12563446 | 1 | 201510 | 0 | ||
| 125634461 | 12563446 | 2 | 201607 | 0 |