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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126164051 | 12616405 | 1 | I | 2005 | 20160726 | 20160802 | 20160802 | EXP | FR-ABBVIE-16P-056-1690415-00 | ABBVIE | 45.05 | YR | M | Y | 0.00000 | 20160802 | MD | FR | FR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126164051 | 12616405 | 1 | PS | NORVIR | RITONAVIR | 1 | Unknown | Y | UNKNOWN | 20945 | |||||||||
| 126164051 | 12616405 | 2 | SS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | 160MG OF LOAD DOSE; 80MG AFTER 2 WEEKS THEN 40MG EOW | Y | UNKNOWN | 125057 | 40 | MG | SOLUTION FOR INJECTION IN PRE-FILLED PEN | QOW | ||||
| 126164051 | 12616405 | 3 | SS | ORBENINE | CLOXACILLIN SODIUM | 1 | Intravenous (not otherwise specified) | Y | UNKNOWN | 0 | 12 | G | QD | ||||||
| 126164051 | 12616405 | 4 | SS | ORBENINE | CLOXACILLIN SODIUM | 1 | Intravenous (not otherwise specified) | Y | UNKNOWN | 0 | 8 | G | QD | ||||||
| 126164051 | 12616405 | 5 | SS | PREZISTA | DARUNAVIR ETHANOLATE | 1 | Oral | UNKNOWN | 0 | ||||||||||
| 126164051 | 12616405 | 6 | SS | TRUVADA | EMTRICITABINETENOFOVIR DISOPROXIL FUMARATE | 1 | Oral | UNKNOWN | 0 | ||||||||||
| 126164051 | 12616405 | 7 | SS | REMICADE | INFLIXIMAB | 1 | Unknown | Y | UNKNOWN | 0 | |||||||||
| 126164051 | 12616405 | 8 | SS | REMICADE | INFLIXIMAB | 1 | Unknown | Y | UNKNOWN | 0 | |||||||||
| 126164051 | 12616405 | 9 | SS | REMICADE | INFLIXIMAB | 1 | Unknown | Y | UNKNOWN | 0 | |||||||||
| 126164051 | 12616405 | 10 | SS | REMICADE | INFLIXIMAB | 1 | Unknown | Y | UNKNOWN | 0 | |||||||||
| 126164051 | 12616405 | 11 | SS | ISENTRESS | RALTEGRAVIR POTASSIUM | 1 | Unknown | U | UNKNOWN | 0 | |||||||||
| 126164051 | 12616405 | 12 | SS | METHOTREXATE. | METHOTREXATE | 1 | Subcutaneous | Y | UNKNOWN | 0 | 25 | MG | /wk | ||||||
| 126164051 | 12616405 | 13 | SS | STELARA | USTEKINUMAB | 1 | Unknown | 90MG AT WEEK0, WEEK2 AND WEEK4 THEN EVERY 8 WEEKS | Y | UNKNOWN | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126164051 | 12616405 | 1 | HIV infection |
| 126164051 | 12616405 | 2 | Crohn's disease |
| 126164051 | 12616405 | 3 | Product used for unknown indication |
| 126164051 | 12616405 | 5 | HIV infection |
| 126164051 | 12616405 | 6 | HIV infection |
| 126164051 | 12616405 | 7 | Product used for unknown indication |
| 126164051 | 12616405 | 11 | Product used for unknown indication |
| 126164051 | 12616405 | 12 | Product used for unknown indication |
| 126164051 | 12616405 | 13 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126164051 | 12616405 | HO |
| 126164051 | 12616405 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126164051 | 12616405 | Acute kidney injury | |
| 126164051 | 12616405 | Anal abscess | |
| 126164051 | 12616405 | Colitis ulcerative | |
| 126164051 | 12616405 | Crohn's disease | |
| 126164051 | 12616405 | Cytomegalovirus infection | |
| 126164051 | 12616405 | Dermatitis exfoliative | |
| 126164051 | 12616405 | Dermo-hypodermitis | |
| 126164051 | 12616405 | Diarrhoea | |
| 126164051 | 12616405 | Enterocolonic fistula | |
| 126164051 | 12616405 | Enterocutaneous fistula | |
| 126164051 | 12616405 | Intestinal ulcer | |
| 126164051 | 12616405 | Myalgia | |
| 126164051 | 12616405 | Neutropenia | |
| 126164051 | 12616405 | Perineal abscess | |
| 126164051 | 12616405 | Prostatitis | |
| 126164051 | 12616405 | Pyrexia | |
| 126164051 | 12616405 | Scrotal abscess | |
| 126164051 | 12616405 | Sepsis | |
| 126164051 | 12616405 | Skin ulcer | |
| 126164051 | 12616405 | Stoma site abscess | |
| 126164051 | 12616405 | Subcutaneous abscess | |
| 126164051 | 12616405 | Testicular abscess | |
| 126164051 | 12616405 | Thrombocytopenia | |
| 126164051 | 12616405 | Urethral fistula |
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 |
|---|---|---|---|---|---|---|
| 126164051 | 12616405 | 2 | 201405 | 0 | ||
| 126164051 | 12616405 | 3 | 20160701 | 0 | ||
| 126164051 | 12616405 | 4 | 20160708 | 20160711 | 0 | |
| 126164051 | 12616405 | 7 | 2006 | 0 | ||
| 126164051 | 12616405 | 8 | 201210 | 0 | ||
| 126164051 | 12616405 | 9 | 201211 | 0 | ||
| 126164051 | 12616405 | 10 | 201301 | 201312 | 0 | |
| 126164051 | 12616405 | 11 | 201501 | 0 | ||
| 126164051 | 12616405 | 12 | 201506 | 20160524 | 0 | |
| 126164051 | 12616405 | 13 | 201508 | 20160419 | 0 |