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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 100501704 | 10050170 | 4 | F | 200907 | 20160630 | 20140401 | 20160707 | EXP | US-ABBVIE-10P-163-0637793-00 | ABBVIE | 25.70 | YR | F | Y | 61.29000 | KG | 20160707 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 100501704 | 10050170 | 1 | PS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | Y | UNKNOWN | 125057 | SOLUTION FOR INJECTION IN PRE-FILLED PEN | QOW | |||||||
| 100501704 | 10050170 | 2 | SS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | Y | UNKNOWN | 125057 | 40 | MG | /wk | ||||||
| 100501704 | 10050170 | 3 | SS | VALIUM | DIAZEPAM | 1 | Oral | Y | UNKNOWN | 0 | 10 | MG | TID | ||||||
| 100501704 | 10050170 | 4 | SS | VALIUM | DIAZEPAM | 1 | Y | UNKNOWN | 0 | ||||||||||
| 100501704 | 10050170 | 5 | C | PROTONIX | PANTOPRAZOLE SODIUM | 1 | 0 | 40 | MG | QD | |||||||||
| 100501704 | 10050170 | 6 | C | PREDNISONE. | PREDNISONE | 1 | Oral | 0 | 10 | MG | |||||||||
| 100501704 | 10050170 | 7 | C | PHENERGAN | PROMETHAZINE HYDROCHLORIDE | 1 | 0 | 25 | MG | ||||||||||
| 100501704 | 10050170 | 8 | C | PHENERGAN | PROMETHAZINE HYDROCHLORIDE | 1 | 0 | ||||||||||||
| 100501704 | 10050170 | 9 | C | PRENATAL VITAMINS | VITAMINS | 1 | Oral | 0 | 1 | DF | TABLET | QD | |||||||
| 100501704 | 10050170 | 10 | C | FOLIC ACID. | FOLIC ACID | 1 | Oral | 0 | 1 | DF | TABLET | QD | |||||||
| 100501704 | 10050170 | 11 | C | INFLUENZA | INFLUENZA VIRUS VACCINE | 1 | Other | 1 SHOT | 0 | 1 | DF | ||||||||
| 100501704 | 10050170 | 12 | C | TYLENOL | ACETAMINOPHEN | 1 | 2 TABS 3.4 DAY | 0 | 1 | DF | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 100501704 | 10050170 | 1 | Crohn's disease |
| 100501704 | 10050170 | 2 | Psoriasis |
| 100501704 | 10050170 | 3 | Crohn's disease |
| 100501704 | 10050170 | 4 | Anxiety |
| 100501704 | 10050170 | 5 | Gastrooesophageal reflux disease |
| 100501704 | 10050170 | 6 | Crohn's disease |
| 100501704 | 10050170 | 7 | Nausea |
| 100501704 | 10050170 | 8 | Crohn's disease |
| 100501704 | 10050170 | 9 | Product used for unknown indication |
| 100501704 | 10050170 | 10 | Product used for unknown indication |
| 100501704 | 10050170 | 11 | Influenza immunisation |
| 100501704 | 10050170 | 12 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 100501704 | 10050170 | OT |
| 100501704 | 10050170 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 100501704 | 10050170 | Anal fistula | |
| 100501704 | 10050170 | Cardiac murmur | |
| 100501704 | 10050170 | Cough | |
| 100501704 | 10050170 | Dizziness | |
| 100501704 | 10050170 | Fall | |
| 100501704 | 10050170 | Fistula | |
| 100501704 | 10050170 | Gastrointestinal infection | |
| 100501704 | 10050170 | Hyperthermia | |
| 100501704 | 10050170 | Malaise | |
| 100501704 | 10050170 | Migraine | |
| 100501704 | 10050170 | Nasopharyngitis | |
| 100501704 | 10050170 | Nausea | |
| 100501704 | 10050170 | Palpitations | |
| 100501704 | 10050170 | Placenta praevia | |
| 100501704 | 10050170 | Premature labour | |
| 100501704 | 10050170 | Premature separation of placenta | |
| 100501704 | 10050170 | Pyrexia | |
| 100501704 | 10050170 | Respiratory tract infection | |
| 100501704 | 10050170 | Road traffic accident | |
| 100501704 | 10050170 | Staphylococcal infection |
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 |
|---|---|---|---|---|---|---|
| 100501704 | 10050170 | 1 | 200811 | 200902 | 0 | |
| 100501704 | 10050170 | 2 | 20090206 | 20100321 | 0 | |
| 100501704 | 10050170 | 3 | 20090706 | 20100321 | 0 | |
| 100501704 | 10050170 | 5 | 20090706 | 20100321 | 0 | |
| 100501704 | 10050170 | 7 | 20090706 | 20100321 | 0 | |
| 100501704 | 10050170 | 9 | 20090706 | 20100321 | 0 | |
| 100501704 | 10050170 | 10 | 20090714 | 20090716 | 0 | |
| 100501704 | 10050170 | 11 | 20091008 | 20091008 | 0 | |
| 100501704 | 10050170 | 12 | 20100213 | 20100217 | 0 |