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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 120292532 | 12029253 | 2 | F | 2014 | 20160629 | 20160207 | 20160707 | EXP | US-ABBVIE-15K-163-1499187-00 | ABBVIE | 45.38 | YR | F | Y | 99.88000 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 120292532 | 12029253 | 1 | PS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | Y | UNKNOWN | 125057 | 40 | MG | SOLUTION FOR INJECTION IN PRE-FILLED PEN | QOW | |||||
| 120292532 | 12029253 | 2 | SS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | Y | UNKNOWN | 125057 | SOLUTION FOR INJECTION IN PRE-FILLED PEN | QOW | |||||||
| 120292532 | 12029253 | 3 | SS | CIMZIA | CERTOLIZUMAB PEGOL | 1 | Unknown | UNKNOWN | 0 | ||||||||||
| 120292532 | 12029253 | 4 | C | HYDROCORTISONE. | HYDROCORTISONE | 1 | 0 | ||||||||||||
| 120292532 | 12029253 | 5 | C | AZATHIOPRINE. | AZATHIOPRINE | 1 | 0 | ||||||||||||
| 120292532 | 12029253 | 6 | C | TOPAMAX | TOPIRAMATE | 1 | 0 | ||||||||||||
| 120292532 | 12029253 | 7 | C | VITAMIN B12 | CYANOCOBALAMIN | 1 | 0 | ||||||||||||
| 120292532 | 12029253 | 8 | C | CALCIUM | CALCIUM | 1 | 0 | ||||||||||||
| 120292532 | 12029253 | 9 | C | VITAMIN D | CHOLECALCIFEROL | 1 | 0 | ||||||||||||
| 120292532 | 12029253 | 10 | C | HYDROCORTISONE. | HYDROCORTISONE | 1 | 0 | ||||||||||||
| 120292532 | 12029253 | 11 | C | HYDROCODONE | HYDROCODONE | 1 | 0 | ||||||||||||
| 120292532 | 12029253 | 12 | C | IMITREX | SUMATRIPTAN SUCCINATE | 1 | 0 | ||||||||||||
| 120292532 | 12029253 | 13 | C | LEVOTHYROXINE. | LEVOTHYROXINE | 1 | 0 | ||||||||||||
| 120292532 | 12029253 | 14 | C | METHADONE | METHADONE HYDROCHLORIDE | 1 | 0 | ||||||||||||
| 120292532 | 12029253 | 15 | C | PROCHLORPERAZINE. | PROCHLORPERAZINE | 1 | 0 | ||||||||||||
| 120292532 | 12029253 | 16 | C | ACIPHEX | RABEPRAZOLE SODIUM | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 120292532 | 12029253 | 1 | Crohn's disease |
| 120292532 | 12029253 | 3 | Crohn's disease |
| 120292532 | 12029253 | 4 | Product used for unknown indication |
| 120292532 | 12029253 | 5 | Crohn's disease |
| 120292532 | 12029253 | 6 | Product used for unknown indication |
| 120292532 | 12029253 | 7 | Product used for unknown indication |
| 120292532 | 12029253 | 8 | Product used for unknown indication |
| 120292532 | 12029253 | 9 | Immune system disorder |
| 120292532 | 12029253 | 10 | Product used for unknown indication |
| 120292532 | 12029253 | 11 | Pain |
| 120292532 | 12029253 | 12 | Migraine |
| 120292532 | 12029253 | 13 | Cushing's syndrome |
| 120292532 | 12029253 | 14 | Pain |
| 120292532 | 12029253 | 15 | Nausea |
| 120292532 | 12029253 | 16 | Gastrooesophageal reflux disease |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 120292532 | 12029253 | HO |
| 120292532 | 12029253 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 120292532 | 12029253 | Abdominal pain | |
| 120292532 | 12029253 | Anxiety | |
| 120292532 | 12029253 | Asthenia | |
| 120292532 | 12029253 | Balance disorder | |
| 120292532 | 12029253 | Blood iron decreased | |
| 120292532 | 12029253 | Cyst | |
| 120292532 | 12029253 | Depression | |
| 120292532 | 12029253 | Dysarthria | |
| 120292532 | 12029253 | Dysphonia | |
| 120292532 | 12029253 | Endometriosis | |
| 120292532 | 12029253 | Fatigue | |
| 120292532 | 12029253 | Hospitalisation | |
| 120292532 | 12029253 | Ileus paralytic | |
| 120292532 | 12029253 | Incorrect dose administered | |
| 120292532 | 12029253 | Influenza like illness | |
| 120292532 | 12029253 | Injection site pain | |
| 120292532 | 12029253 | Malaise | |
| 120292532 | 12029253 | Nasopharyngitis | |
| 120292532 | 12029253 | Neuralgia | |
| 120292532 | 12029253 | Paranoia | |
| 120292532 | 12029253 | Pyrexia | |
| 120292532 | 12029253 | Surgery | |
| 120292532 | 12029253 | Tremor | |
| 120292532 | 12029253 | Weight increased | |
| 120292532 | 12029253 | White blood cell count decreased | |
| 120292532 | 12029253 | Wrong technique in product usage process |
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 |
|---|---|---|---|---|---|---|
| 120292532 | 12029253 | 1 | 2011 | 2014 | 0 | |
| 120292532 | 12029253 | 2 | 2014 | 0 | ||
| 120292532 | 12029253 | 3 | 2014 | 2014 | 0 |